Trial Outcomes & Findings for Effects of Walkasins on Gait Speed of Individuals With Mild Cognitive Impairments (NCT NCT05723822)
NCT ID: NCT05723822
Last Updated: 2023-06-05
Results Overview
The 4-meter gait speed test measures the number of seconds it takes a person to walk four meters on a level surface. Gait speed measures are a significant indicator of a person's functional mobility. Higher gait speeds (meters/second) are better than lower gait speeds and are indicative of better functional mobility. (Generally, gait speeds less than 1m/second are considered slow.)
COMPLETED
NA
12 participants
3 Times During 1 Session <1.5 Hours (Screening + Walkasins Off Condition then Walkasins On Condition)
2023-06-05
Participant Flow
Participant milestones
| Measure |
Walkasins and PhySens-IMM System--Single Arm
Participants who meet the eligibility criteria will don a pair of Walkasins and the PhySens-IMM System. They will perform some brief balance exercises (i.e., sensory integration exercises) and then complete the outcome assessments first with their Walkasins turned off and without the use of an assistive device. After a rest period of about five minutes, they will repeat the outcome assessments with their Walkasins turned on.
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|---|---|
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
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12
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Walkasins on Gait Speed of Individuals With Mild Cognitive Impairments
Baseline characteristics by cohort
| Measure |
Walkasins and PhySens-IMM System--Single Arm
n=12 Participants
Participants who meet the eligibility criteria will don a pair of Walkasins and the PhySens-IMM System. They will perform some brief balance exercises (i.e., sensory integration exercises) and then complete the outcome assessments first with their Walkasins turned off and without the use of an assistive device. After a rest period of about five minutes, they will repeat the outcome assessments with their Walkasins turned on.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=99 Participants
|
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Age, Categorical
>=65 years
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12 Participants
n=99 Participants
|
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Age, Continuous
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84.8 Years
STANDARD_DEVIATION 7.4 • n=99 Participants
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Sex: Female, Male
Female
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9 Participants
n=99 Participants
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Sex: Female, Male
Male
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3 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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11 Participants
n=99 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
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Region of Enrollment
United States
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12 participants
n=99 Participants
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Saint Louis University Mental Status (SLUMS) Test
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23.5 Score on a Scale
STANDARD_DEVIATION 2.6 • n=99 Participants
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PRIMARY outcome
Timeframe: 3 Times During 1 Session <1.5 Hours (Screening + Walkasins Off Condition then Walkasins On Condition)The 4-meter gait speed test measures the number of seconds it takes a person to walk four meters on a level surface. Gait speed measures are a significant indicator of a person's functional mobility. Higher gait speeds (meters/second) are better than lower gait speeds and are indicative of better functional mobility. (Generally, gait speeds less than 1m/second are considered slow.)
Outcome measures
| Measure |
Walkasins and PhySens-IMM System--Single Arm
n=12 Participants
Participants who meet the eligibility criteria will don a pair of Walkasins and the PhySens-IMM System. They will perform some brief balance exercises (i.e., sensory integration exercises) and then complete the outcome assessments first with their Walkasins turned off and without the use of an assistive device. After a rest period of about five minutes, they will repeat the outcome assessments with their Walkasins turned on.
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|---|---|
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Change in 4-Meter Gait Speed (Section 2 of the Short Physical Performance Battery)
Baseline Assessment for Eligibility
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0.79 Meters/Second
Standard Deviation 0.16
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Change in 4-Meter Gait Speed (Section 2 of the Short Physical Performance Battery)
Walkasins OFF
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0.82 Meters/Second
Standard Deviation 0.18
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Change in 4-Meter Gait Speed (Section 2 of the Short Physical Performance Battery)
Walkasins ON
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0.79 Meters/Second
Standard Deviation 0.20
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SECONDARY outcome
Timeframe: Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)The Short Physical Performance Battery measures walking speed, standing balance, and sit-to-stand performance. Scores on balance, gait speed, and chair-stand tests are added (summed) for a total score. (Scores on balance, gait speed, and chair-stand tests are not reported separately since they are not "subscales" per se.) SPPB scores may range from 0 to 12. Higher total scores indicate better balance and gait.
Outcome measures
| Measure |
Walkasins and PhySens-IMM System--Single Arm
n=12 Participants
Participants who meet the eligibility criteria will don a pair of Walkasins and the PhySens-IMM System. They will perform some brief balance exercises (i.e., sensory integration exercises) and then complete the outcome assessments first with their Walkasins turned off and without the use of an assistive device. After a rest period of about five minutes, they will repeat the outcome assessments with their Walkasins turned on.
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|---|---|
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Short Physical Performance Battery (SPPB)
Walkasins OFF
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8.2 Score on a Scale
Standard Deviation 1.9
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Short Physical Performance Battery (SPPB)
.Walkasins ON
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7.5 Score on a Scale
Standard Deviation 2.1
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SECONDARY outcome
Timeframe: Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)The Timed Up and Go Test is part of the Centers for Disease Control (CDC)-recommended STEADI test protocol for balance function. From a seated position in a standard armchair, the participant is asked to stand up from the chair, walk to a line on the floor 10 feet away at normal pace, turn, walk back to the chair at normal pace, and sit down again. The tester records the time taken from the command "Go" until the subject sits down again. Lower times indicate better/faster performance.
Outcome measures
| Measure |
Walkasins and PhySens-IMM System--Single Arm
n=12 Participants
Participants who meet the eligibility criteria will don a pair of Walkasins and the PhySens-IMM System. They will perform some brief balance exercises (i.e., sensory integration exercises) and then complete the outcome assessments first with their Walkasins turned off and without the use of an assistive device. After a rest period of about five minutes, they will repeat the outcome assessments with their Walkasins turned on.
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|---|---|
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Timed Up and Go (TUG)
Walkasins OFF
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15.46 Seconds
Standard Deviation 5.4
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Timed Up and Go (TUG)
Walkasins ON
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15.83 Seconds
Standard Deviation 5.66
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SECONDARY outcome
Timeframe: Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)The TUG-COG is performed similarly to the TUG; however, the participant is also asked to count backwards by 3 from a randomly selected number between 20 and 100 while performing the TUG (standing up from the chair, walking to a line on the floor 10 feet away, turning, walking back to the chair at a normal pace, and sitting down again). Lower times indicate better/faster performance.
Outcome measures
| Measure |
Walkasins and PhySens-IMM System--Single Arm
n=12 Participants
Participants who meet the eligibility criteria will don a pair of Walkasins and the PhySens-IMM System. They will perform some brief balance exercises (i.e., sensory integration exercises) and then complete the outcome assessments first with their Walkasins turned off and without the use of an assistive device. After a rest period of about five minutes, they will repeat the outcome assessments with their Walkasins turned on.
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|---|---|
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Timed Up and Go Cognitive (TUG-COG)
Walkasins OFF
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21.64 Seconds
Standard Deviation 7.10
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Timed Up and Go Cognitive (TUG-COG)
Walkasins ON
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18.85 Seconds
Standard Deviation 6.96
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SECONDARY outcome
Timeframe: Once During 1 Session <1.5 HoursThe Falls Efficacy Scale is a 16-item questionnaire that measures an individual's fear of falling or concerns about falling during activities of daily living. Scores may range from 16 (not at all concerned) to 64 (very concerned). Lower scores are better than higher scores because they indicate less concern about falling.
Outcome measures
| Measure |
Walkasins and PhySens-IMM System--Single Arm
n=12 Participants
Participants who meet the eligibility criteria will don a pair of Walkasins and the PhySens-IMM System. They will perform some brief balance exercises (i.e., sensory integration exercises) and then complete the outcome assessments first with their Walkasins turned off and without the use of an assistive device. After a rest period of about five minutes, they will repeat the outcome assessments with their Walkasins turned on.
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|---|---|
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Falls Efficacy Scale
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32.2 Score on a Scale
Standard Deviation 7.6
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Adverse Events
Walkasins and PhySens-IMM System--Single Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place