Trial Outcomes & Findings for Evaluating Wearable Robotic Assistance on Gait (NCT NCT04119063)
NCT ID: NCT04119063
Last Updated: 2024-01-10
Results Overview
The change in the metabolic energy required to walk will be measured using a portable metabolic measurement system (Cosmed K5). Units: change in % difference post vs pre gait training.
COMPLETED
EARLY_PHASE1
6 participants
Measured at the pre (day 1) and post (day 4) gait training assessments
2024-01-10
Participant Flow
All participants first completed higher frequency gait training followed by a washout period and then lower frequency gait training.
Participant milestones
| Measure |
Gait Training With Exoskeleton Assistance
All participants received high frequency gait training followed by a washout period then low frequency gait training
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating Wearable Robotic Assistance on Gait
Baseline characteristics by cohort
| Measure |
Exoskeleton Assistance
n=6 Participants
Gait training with exoskeleton assistance at higher and lower frequencies.
powered orthosis: Novel powered leg brace to provide assistance during walking.
|
|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at the pre (day 1) and post (day 4) gait training assessmentsThe change in the metabolic energy required to walk will be measured using a portable metabolic measurement system (Cosmed K5). Units: change in % difference post vs pre gait training.
Outcome measures
| Measure |
Exoskeleton Gait Training High Frequency
n=6 Participants
Gait training with ankle exoskeleton assistance at the higher frequency.
|
Exoskeleton Gait Training Low Frequency
n=6 Participants
Gait training with ankle exoskeleton assistance at the lower frequency.
|
|---|---|---|
|
The Metabolic Energy Required to Walk
|
2.42 % change pre vs post gait training
Standard Deviation 16.87
|
-2.14 % change pre vs post gait training
Standard Deviation 10.59
|
PRIMARY outcome
Timeframe: Measured at the pre (day 1) and post (day 4) gait training assessmentsThe change in the walking speed will be measured over-ground using a stop watch. Units: % change between post vs pre assessments
Outcome measures
| Measure |
Exoskeleton Gait Training High Frequency
n=6 Participants
Gait training with ankle exoskeleton assistance at the higher frequency.
|
Exoskeleton Gait Training Low Frequency
n=6 Participants
Gait training with ankle exoskeleton assistance at the lower frequency.
|
|---|---|---|
|
Change in Walking Speed
|
25.39 % change post vs pre training
Standard Deviation 14.65
|
8.09 % change post vs pre training
Standard Deviation 7.10
|
SECONDARY outcome
Timeframe: Measured at the pre (day 1) and post (day 4) gait training assessmentsThe change in the stride length will be measured by dividing the number of steps by distance traveled. Units: % change between post vs pre assessments.
Outcome measures
| Measure |
Exoskeleton Gait Training High Frequency
n=6 Participants
Gait training with ankle exoskeleton assistance at the higher frequency.
|
Exoskeleton Gait Training Low Frequency
n=6 Participants
Gait training with ankle exoskeleton assistance at the lower frequency.
|
|---|---|---|
|
Change in Stride Length
|
16.28 % change post vs pre training
Standard Deviation 9.90
|
3.87 % change post vs pre training
Standard Deviation 5.00
|
SECONDARY outcome
Timeframe: Measured at the pre (day 1) and post (day 4) gait training assessmentsThe change in the number of steps taken per minute will be measured using a counter. Units: % change between post vs pre assessments.
Outcome measures
| Measure |
Exoskeleton Gait Training High Frequency
n=6 Participants
Gait training with ankle exoskeleton assistance at the higher frequency.
|
Exoskeleton Gait Training Low Frequency
n=6 Participants
Gait training with ankle exoskeleton assistance at the lower frequency.
|
|---|---|---|
|
Change in Cadence
|
22.47 % change post vs pre training
Standard Deviation 35.18
|
4.04 % change post vs pre training
Standard Deviation 3.32
|
SECONDARY outcome
Timeframe: Measured at the pre (day 1) and post (day 4) gait training assessmentsThe change in the muscle activity variance ratio of the soleus during walking will be measured using electromyography electrodes. Units: % change between post vs pre assessments.
Outcome measures
| Measure |
Exoskeleton Gait Training High Frequency
n=6 Participants
Gait training with ankle exoskeleton assistance at the higher frequency.
|
Exoskeleton Gait Training Low Frequency
n=6 Participants
Gait training with ankle exoskeleton assistance at the lower frequency.
|
|---|---|---|
|
Change in Muscle Activity Variance Ratio
|
-47.24 % change post vs pre training
Standard Deviation 17.44
|
18.80 % change post vs pre training
Standard Deviation 29.97
|
Adverse Events
Gait Training With Exoskeleton Assistance High Frequency
Gait Training With Exoskeleton Assistance Low Frequency
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Zach Lerner, Associate Professor
Northern Arizona University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place