Trial Outcomes & Findings for Sensory Augmentation Methods in Stroke (NCT NCT03988400)
NCT ID: NCT03988400
Last Updated: 2024-09-19
Results Overview
The investigators will monitor the safety of the intervention by quantifying the percentage of participants who experience an adverse event potentially related to the intervention (e.g. skin irritation; falls) or any serious adverse event (e.g. hospitalization; death). This information is gathered through participant self-report, or through communication with participant caregiver if necessary.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
44 participants
Primary outcome timeframe
Cumulative over the course of the 4-week intervention
Results posted on
2024-09-19
Participant Flow
Participants were recruited and enrolled into this study between April of 2022 and March of 2023. All participants were recruited from the RESTORE database at the Medical University of South Carolina.
Participants completed an initial assessment session prior to their assignment to a study arm/group. No qualified participants were enrolled into the study, but then excluded from the study before group assignment.
Participant milestones
| Measure |
Sensory Augmentation
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
Sensory Augmentation: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
|
Random Vibration
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
Random Vibration: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Sensory Augmentation
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
Sensory Augmentation: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
|
Random Vibration
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
Random Vibration: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Macular degeneration, unrelated to study procedures.
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Sensory Augmentation Methods in Stroke
Baseline characteristics by cohort
| Measure |
Sensory Augmentation
n=22 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
Sensory Augmentation: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
|
Random Vibration
n=22 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
Random Vibration: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 12 • n=99 Participants
|
57 years
STANDARD_DEVIATION 12 • n=107 Participants
|
60 years
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Mechanics-dependent Adjustment of Paretic Foot Placement
|
-.145 Unitless (correlation coefficient)
STANDARD_DEVIATION .253 • n=99 Participants
|
-.043 Unitless (correlation coefficient)
STANDARD_DEVIATION .236 • n=107 Participants
|
-.094 Unitless (correlation coefficient)
STANDARD_DEVIATION .247 • n=206 Participants
|
|
Mechanics-dependent adjustment of Non-paretic Foot Placement
|
-.192 Unitless (correlation coefficient)
STANDARD_DEVIATION .231 • n=99 Participants
|
-.075 Unitless (correlation coefficient)
STANDARD_DEVIATION .254 • n=107 Participants
|
-.134 Unitless (correlation coefficient)
STANDARD_DEVIATION .247 • n=206 Participants
|
|
Fear of Falling
|
8 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Functional Gait Assessment score
|
15.27 units on a scale
STANDARD_DEVIATION 5.81 • n=99 Participants
|
15.23 units on a scale
STANDARD_DEVIATION 4.66 • n=107 Participants
|
15.25 units on a scale
STANDARD_DEVIATION 5.20 • n=206 Participants
|
|
Activities-specific Balance Confidence scale score
|
65.0 units on a scale
STANDARD_DEVIATION 20.0 • n=99 Participants
|
64.2 units on a scale
STANDARD_DEVIATION 19.7 • n=107 Participants
|
64.6 units on a scale
STANDARD_DEVIATION 19.6 • n=206 Participants
|
|
Self-selected overground walking speed
|
0.82 meter per second
STANDARD_DEVIATION 0.30 • n=99 Participants
|
0.75 meter per second
STANDARD_DEVIATION 0.27 • n=107 Participants
|
0.79 meter per second
STANDARD_DEVIATION 0.29 • n=206 Participants
|
PRIMARY outcome
Timeframe: Cumulative over the course of the 4-week interventionPopulation: Analysis was performed on all participants who began the intervention.
The investigators will monitor the safety of the intervention by quantifying the percentage of participants who experience an adverse event potentially related to the intervention (e.g. skin irritation; falls) or any serious adverse event (e.g. hospitalization; death). This information is gathered through participant self-report, or through communication with participant caregiver if necessary.
Outcome measures
| Measure |
Sensory Augmentation
n=22 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
Sensory Augmentation: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
|
Random Vibration
n=22 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
Random Vibration: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
|
|---|---|---|
|
Percentage of Participants With Related or Serious Adverse Events
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Cumulative over the course of the 4-week interventionPopulation: Data was analyzed for all participants who completed the final assessment session.
The investigators will assess participant adherence as the number of training sessions attended (out of a maximum possible number of 8).
Outcome measures
| Measure |
Sensory Augmentation
n=20 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
Sensory Augmentation: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
|
Random Vibration
n=21 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
Random Vibration: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
|
|---|---|---|
|
Number of Training Sessions Attended
|
7 Visits attended
Interval 3.0 to 8.0
|
8 Visits attended
Interval 6.0 to 8.0
|
PRIMARY outcome
Timeframe: 4-weeksPopulation: Data from all participants enrolled in this study was analyzed.
The investigators will assess participant drop-out as the number of participants who do not attend the final Assessment Session.
Outcome measures
| Measure |
Sensory Augmentation
n=22 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
Sensory Augmentation: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
|
Random Vibration
n=22 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
Random Vibration: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
|
|---|---|---|
|
Intervention Feasibility (Drop-out)
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 4-weeksPopulation: Analyses included participants who completed the final assessment session.
The primary effectiveness measure will be the change in participants' gait stabilization strategy over the course of the 4-week intervention. This will be quantified as the partial correlation between paretic mediolateral foot placement and mediolateral pelvis displacement at the start of the step over a 2-minute period of walking. The investigators will calculate the change in this metric from the initial (Week 0) assessment session to the final (Week 4) assessment session.
Outcome measures
| Measure |
Sensory Augmentation
n=20 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
Sensory Augmentation: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
|
Random Vibration
n=21 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
Random Vibration: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
|
|---|---|---|
|
Change in Mechanics-dependent Adjustment of Paretic Foot Placement
|
0.078 Unitless (correlation coefficient)
Interval 0.002 to 0.154
|
0.054 Unitless (correlation coefficient)
Interval -0.053 to 0.16
|
SECONDARY outcome
Timeframe: Cumulative over the course of the 4-week interventionPopulation: Data was analyzed for all participants who completed the final assessment session.
The investigators will quantify the total walking time across all training sessions (out of a maximum possible 312 minutes).
Outcome measures
| Measure |
Sensory Augmentation
n=20 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
Sensory Augmentation: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
|
Random Vibration
n=21 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
Random Vibration: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
|
|---|---|---|
|
Intervention Feasibility (Walking Time)
|
144 Minutes of walking
Interval 72.0 to 297.0
|
255 Minutes of walking
Interval 75.0 to 312.0
|
SECONDARY outcome
Timeframe: 4-weeksPopulation: Analysis was performed for all participants who completed the final assessment session.
The investigators will assess the change in fear of falling (identified using a yes/no question of "do you have a fear of falling?") from the initial (Week 0) assessment session to the final (Week 4) assessment session.
Outcome measures
| Measure |
Sensory Augmentation
n=20 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
Sensory Augmentation: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
|
Random Vibration
n=21 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
Random Vibration: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
|
|---|---|---|
|
Change in Fear of Falling
Fear of falling in initial assessment session
|
8 Participants
|
10 Participants
|
|
Change in Fear of Falling
Fear of falling in final assessment session
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 4-weeksThe investigators will quantify the change in Functional Gait Assessment score from the initial (Week 0) assessment session to the final (Week 4) assessment session. The initial score will be subtracted from the final score. The minimum value is 0, the maximum value is 30, and higher scores indicate a better outcome.
Outcome measures
| Measure |
Sensory Augmentation
n=20 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
Sensory Augmentation: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
|
Random Vibration
n=21 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
Random Vibration: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
|
|---|---|---|
|
Change in Functional Gait Assessment Score
|
0.8 score on a scale
Interval -0.5 to 2.0
|
1.7 score on a scale
Interval 0.7 to 2.7
|
SECONDARY outcome
Timeframe: 4-weeksPopulation: Data was analyzed for participants who completed the final assessment session.
The investigators will quantify the change in Activity-specific Balance Confidence score from the initial (Week 0) assessment session to the final (Week 4) assessment session. The initial score will be subtracted from the final score. The minimum value is 0, the maximum value is 100, and higher scores indicate a better outcome.
Outcome measures
| Measure |
Sensory Augmentation
n=20 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
Sensory Augmentation: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
|
Random Vibration
n=21 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
Random Vibration: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
|
|---|---|---|
|
Change in Activity-specific Balance Confidence Score
|
1.0 score on a scale
Interval -3.2 to 5.1
|
2.1 score on a scale
Interval -1.8 to 6.0
|
SECONDARY outcome
Timeframe: 4-weeksPopulation: Data was analyzed for participants who completed the final assessment session.
The investigators will quantify the change in overground self-selected gait speed from the initial (Week 0) assessment session to the final (Week 4) assessment session. The initial score will be subtracted from the final score.
Outcome measures
| Measure |
Sensory Augmentation
n=20 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
Sensory Augmentation: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
|
Random Vibration
n=21 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
Random Vibration: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
|
|---|---|---|
|
Change in Overground Self-selected Gait Speed
|
0.01 meters per second
Interval -0.04 to 0.05
|
0.05 meters per second
Interval 0.0 to 0.1
|
POST_HOC outcome
Timeframe: 4-weeksPopulation: Analyses included participants who completed the final assessment session.
This not pre-planned effectiveness measure is the change in participant's gait stabilization over the course of the 4-week intervention for steps taken with the non-paretic leg. This was quantified as the partial correlation between non-paretic mediolateral foot placement and mediolateral pelvis displacement at the start of the step over a 2-minute period of walking. The change in this metric was calculated from the initial (Week 0) assessment session to the final (Week 4) assessment session. The initial score was subtracted from the final score.
Outcome measures
| Measure |
Sensory Augmentation
n=20 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
Sensory Augmentation: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
|
Random Vibration
n=21 Participants
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
Random Vibration: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
|
|---|---|---|
|
Change in Mechanics-dependent Adjustment of Non-paretic Foot Placement
|
0.073 Unitless (correlation coefficient)
Interval -0.02 to 0.167
|
0.037 Unitless (correlation coefficient)
Interval -0.067 to 0.141
|
Adverse Events
Sensory Augmentation
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Random Vibration
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sensory Augmentation
n=22 participants at risk
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
Sensory Augmentation: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
|
Random Vibration
n=22 participants at risk
Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
Random Vibration: Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
|
|---|---|---|
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Vascular disorders
Stroke
|
4.5%
1/22 • Number of events 1 • Adverse event data were collected over the period spanning from the participant's initial assessment session through their final assessment session. This duration was approximately 5 weeks (initial assessment session; 4 weeks of training; final assessment session).
The investigators followed the Clinicaltrials.gov definition.
|
0.00%
0/22 • Adverse event data were collected over the period spanning from the participant's initial assessment session through their final assessment session. This duration was approximately 5 weeks (initial assessment session; 4 weeks of training; final assessment session).
The investigators followed the Clinicaltrials.gov definition.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place