Trial Outcomes & Findings for Fall-recovery Training for Those With Chronic Stroke and Low Falls Self-efficacy (NCT NCT04112173)
NCT ID: NCT04112173
Last Updated: 2023-09-25
Results Overview
The number of participants who end participation due to adverse events
TERMINATED
NA
1 participants
6 months
2023-09-25
Participant Flow
One participant recruited on 2/21/2020 at University of Delaware campus.
Participant milestones
| Measure |
Perturbation-based Balance Training
perturbation-based balance training
perturbation-based fall-recovery training: Participants will attempt to recover from treadmill-induced balance perturbations as they walk or stand. The size of the perturbations is progressively challenging and dependent upon participant performance.
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|---|---|
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Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
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Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Perturbation-based Balance Training
perturbation-based balance training
perturbation-based fall-recovery training: Participants will attempt to recover from treadmill-induced balance perturbations as they walk or stand. The size of the perturbations is progressively challenging and dependent upon participant performance.
|
|---|---|
|
Overall Study
Study terminated due to COVID-19 pandemic
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1
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Baseline Characteristics
Fall-recovery Training for Those With Chronic Stroke and Low Falls Self-efficacy
Baseline characteristics by cohort
| Measure |
Intervention
n=1 Participants
perturbation-based balance training
perturbation-based fall-recovery training: Participants will attempt to recover from treadmill-induced balance perturbations as they walk or stand. The size of the perturbations is progressively challenging and dependent upon participant performance.
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|---|---|
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Age, Continuous
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56 years
n=99 Participants
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Sex: Female, Male
Female
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0 Participants
n=99 Participants
|
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Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
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
|
1 Participants
n=99 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
0 Participants
n=99 Participants
|
|
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
|
1 Participants
n=99 Participants
|
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Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
|
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Balance Confidence
|
52 units on a scale
n=99 Participants
|
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Lower Extremity Fugl-Meyer
|
20 units on a scale
n=99 Participants
|
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Stroke Impact Scale
Strength
|
12.5 units on a scale
n=99 Participants
|
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Stroke Impact Scale
Memory and Thinking
|
83.3 units on a scale
n=99 Participants
|
|
Stroke Impact Scale
Emotions
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83.3 units on a scale
n=99 Participants
|
|
Stroke Impact Scale
Communication
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64.3 units on a scale
n=99 Participants
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Stroke Impact Scale
ADL/IADL
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70 units on a scale
n=99 Participants
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Stroke Impact Scale
Mobility
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66.7 units on a scale
n=99 Participants
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Stroke Impact Scale
Hand Function
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0 units on a scale
n=99 Participants
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Stroke Impact Scale
Participation/Role
|
68.8 units on a scale
n=99 Participants
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|
Anteroposterior stepping thresholds
Anterior
|
1 m/s^2
n=99 Participants
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|
Anteroposterior stepping thresholds
Posterior
|
2.5 m/s^2
n=99 Participants
|
|
Falls Efficacy Scale
|
38 units on a scale
n=99 Participants
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PRIMARY outcome
Timeframe: 6 monthsPopulation: The study was terminated prior to reaching the pre-specified time frame for recording this data. This outcome measure was not recorded.
The number of participants who end participation due to adverse events
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 monthsPopulation: The study was terminated prior to reaching the pre-specified time frame for recording this data. This outcome measure was not recorded.
Balance confidence, as measured by the Activities Specific Balance Confidence questionnaire. Scores range from 0 to 100, and represent the average rating of each question. Higher scores indicate more confidence. Range 0-100 Higher values represent a better outcome.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 monthsPopulation: The study was terminated prior to reaching the pre-specified time frame for recording this data. This outcome measure was not recorded.
Falls Self-Efficacy, as measured by the Falls Self-Efficacy Scale. Scores are totaled, ranging from 16-64, with higher scores representing worse self-efficacy.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 monthsPopulation: The study was terminated prior to reaching the pre-specified time frame for recording this data. This outcome measure was not recorded.
Average steps/day, as measured by a step monitor
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: The study was terminated prior to reaching the pre-specified time frame for recording this data. This outcome measure was not recorded.
Stepping thresholds are the treadmill-induced, standing perturbation magnitudes that elicit anterior, posterior, or lateral steps. These thresholds are determined from a series of progressively challenging perturbations, delivered as participants stand on a computer-controlled treadmill. The thresholds are the size of the perturbation (measured as acceleration) that results in a step for four trial. Participants are instructed to try not to step. One progression consists of forward and backward perturbations to determine anterior and posterior thresholds. A second progression is done with participants facing the side of the treadmill, with the progression identifying left and right stepping thresholds. Anterior, posterior, left, and right thresholds are considered independently (i.e. not averaged or summed).
Outcome measures
Outcome data not reported
Adverse Events
Intervention
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