Trial Outcomes & Findings for Optimizing Ankle Exoskeleton Assistance for Walking Across the Life Span (NCT NCT04033146)
NCT ID: NCT04033146
Last Updated: 2024-06-21
Results Overview
The rate of metabolic energy that participants expend during a short walking bout in each of the experimental conditions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
3rd session, up to 2 weeks
Results posted on
2024-06-21
Participant Flow
Participants were enrolled and participated in the study from 2/4/2020 to 5/23/2023.
Participant milestones
| Measure |
Young Adult Exoskeleton Users
Study participants who are 18-45 year old.
|
Older Adult Exoskeleton Users
Study participants who are \>65 years old
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
|
Overall Study
COMPLETED
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Young Adult Exoskeleton Users
n=10 Participants
Study participants who are 18-45 year old.
|
Older Adult Exoskeleton Users
n=6 Participants
Study participants who are \>65 years old
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=16 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
10 Participants
n=16 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=16 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=10 Participants
|
5 Participants
n=6 Participants
|
8 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=10 Participants
|
1 Participants
n=6 Participants
|
8 Participants
n=16 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 3rd session, up to 2 weeksThe rate of metabolic energy that participants expend during a short walking bout in each of the experimental conditions.
Outcome measures
| Measure |
Young Adult Exoskeleton Users
n=10 Participants
Study participants who are 18-45 year old.
Ankle Exoskeleton Assistance: The investigators will use ankle-exoskeletons to modulate the amount of mechanical power generated by the user's ankle joint. That is, participants will walk in a robotic device that either (a) adds a spring or (b) a motor in parallel with their calf muscles to help them generate a stronger propulsive push-off that could reduce the effort of walking.
|
Older Adult Exoskeleton Users
n=6 Participants
Study participants who are greater than 65 years of age.
Ankle Exoskeleton Assistance: The investigators will use ankle-exoskeletons to modulate the amount of mechanical power generated by the user's ankle joint. That is, participants will walk in a robotic device that either (a) adds a spring or (b) a motor in parallel with their calf muscles to help them generate a stronger propulsive push-off that could reduce the effort of walking.
|
|---|---|---|
|
Net Metabolic Rate (Watts/kg)
No Exoskeleton
|
3.30 watts/kg
Standard Deviation 0.66
|
3.47 watts/kg
Standard Deviation 0.31
|
|
Net Metabolic Rate (Watts/kg)
No Torque
|
3.86 watts/kg
Standard Deviation 0.62
|
4.18 watts/kg
Standard Deviation 0.62
|
|
Net Metabolic Rate (Watts/kg)
Spring-like Torque
|
3.72 watts/kg
Standard Deviation 0.78
|
4.34 watts/kg
Standard Deviation 0.57
|
|
Net Metabolic Rate (Watts/kg)
Motor-like Low Torque
|
3.51 watts/kg
Standard Deviation 0.83
|
3.68 watts/kg
Standard Deviation 0.65
|
|
Net Metabolic Rate (Watts/kg)
Motor-like Medium Torque
|
3.13 watts/kg
Standard Deviation 0.70
|
3.46 watts/kg
Standard Deviation 0.56
|
|
Net Metabolic Rate (Watts/kg)
Motor-like High Torque
|
3.24 watts/kg
Standard Deviation 0.65
|
3.20 watts/kg
Standard Deviation 0.52
|
Adverse Events
Young Adult Exoskeleton Users
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Older Adult Exoskeleton Users
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
Dr. Gregory S. Sawicki; Professor Mechanical Engineering
Georgia Insitute of Technology
Phone: 919 448 5099
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place