Trial Outcomes & Findings for Ankle Assistance and Resistance in Older Adults (NCT NCT06284525)
NCT ID: NCT06284525
Last Updated: 2025-10-01
Results Overview
Change (post - baseline) in six minute walk test distance (distance in meters)
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
9 participants
Primary outcome timeframe
Baseline assessment and 1-week post training assessment (at 5 weeks)
Results posted on
2025-10-01
Participant Flow
Participant milestones
| Measure |
Gait Training With Exoskeleton Resistance
Participants will complete 20-30 minutes of ankle resistance training on each visit. This will involve walking on a treadmill with stance phase ankle resistance and biofeedback.
Ankle resistance and biofeedback: An ankle exoskeleton will provide stance phase resistance and a plantar pressure biofeedback system will encourage late stance push-off.
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|---|---|
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Overall Study
STARTED
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9
|
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Overall Study
COMPLETED
|
8
|
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Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Gait Training With Exoskeleton Resistance
Participants will complete 20-30 minutes of ankle resistance training on each visit. This will involve walking on a treadmill with stance phase ankle resistance and biofeedback.
Ankle resistance and biofeedback: An ankle exoskeleton will provide stance phase resistance and a plantar pressure biofeedback system will encourage late stance push-off.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Gait Training With Exoskeleton Resistance
n=8 Participants
Participants will complete 20-30 minutes of ankle resistance training on each visit. This will involve walking on a treadmill with stance phase ankle resistance and biofeedback.
Ankle resistance and biofeedback: An ankle exoskeleton will provide stance phase resistance and a plantar pressure biofeedback system will encourage late stance push-off.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
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0 Participants
n=8 Participants
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Age, Categorical
>=65 years
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8 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=8 Participants
|
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Sex: Female, Male
Male
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4 Participants
n=8 Participants
|
|
Region of Enrollment
United States
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8 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline assessment and 1-week post training assessment (at 5 weeks)Change (post - baseline) in six minute walk test distance (distance in meters)
Outcome measures
| Measure |
Gait Training With Exoskeleton Resistance
n=8 Participants
Participants will complete 20-30 minutes of ankle resistance training on each visit. This will involve walking on a treadmill with stance phase ankle resistance and biofeedback.
Ankle resistance and biofeedback: An ankle exoskeleton will provide stance phase resistance and a plantar pressure biofeedback system will encourage late stance push-off.
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|---|---|
|
Change in 6MWT
|
48.3 m
Standard Deviation 50.5
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PRIMARY outcome
Timeframe: Baseline assessment and 1-week post training assessment (at 5 weeks)Change (post - baseline) in metabolic power measured in J/(kgm)
Outcome measures
| Measure |
Gait Training With Exoskeleton Resistance
n=8 Participants
Participants will complete 20-30 minutes of ankle resistance training on each visit. This will involve walking on a treadmill with stance phase ankle resistance and biofeedback.
Ankle resistance and biofeedback: An ankle exoskeleton will provide stance phase resistance and a plantar pressure biofeedback system will encourage late stance push-off.
|
|---|---|
|
Change in Metabolic Power
|
-0.09 J/(kgm)
Standard Deviation 0.58
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PRIMARY outcome
Timeframe: Baseline assessment and 1-week post training assessment (at 5 weeks)Change (post - baseline) in manual muscle testing plantar flexor force production measured in N/kg
Outcome measures
| Measure |
Gait Training With Exoskeleton Resistance
n=8 Participants
Participants will complete 20-30 minutes of ankle resistance training on each visit. This will involve walking on a treadmill with stance phase ankle resistance and biofeedback.
Ankle resistance and biofeedback: An ankle exoskeleton will provide stance phase resistance and a plantar pressure biofeedback system will encourage late stance push-off.
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|---|---|
|
Change in Plantar Flexor Force Production
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0.6 N/kg
Standard Deviation 0.2
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Adverse Events
Gait Training With Exoskeleton Resistance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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