Trial Outcomes & Findings for NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations) (NCT NCT06269367)
NCT ID: NCT06269367
Last Updated: 2025-12-23
Results Overview
Changes in gait speed (from baseline) as measured using the 10 Meter Walk Test between the experimental (NewGait) and control conditions. Participants were timed during the 10 Meter Walk Test to determine their self-selected gait speed while walking overground in a hallway. In this test, participants walked down a 14 meter walkway, and a stopwatch was used to time how long it took participants to cross the intermediate 10 meter distance. The baseline measure for the first device was taken immediately prior to the intervention. Participants then wore the first device, and the during-training measure was taken immediately. After this, participants received training with the device for about 15 minutes, following which, the device was removed and the post-intervention measure was taken immediately for the first device. Participants then rested for 20-30 minutes. This entire process was repeated with the second device. All measures were obtained on the same day.
COMPLETED
NA
20 participants
Up to 2 hours
2025-12-23
Participant Flow
Participant milestones
| Measure |
NewGait/Control
Participants will put on the NewGait device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training.
NewGait: wearable limb orthotic device
Following this, participants will put on the Control device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training.
Control wearable limb orthotic device: wearable limb orthotic device
|
Control/NewGait
Participants will put on the Control device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training.
Control wearable limb orthotic device: wearable limb orthotic device
Following this, participants will put on the NewGait device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training.
NewGait: wearable limb orthotic device
|
|---|---|---|
|
Phase I
STARTED
|
10
|
10
|
|
Phase I
COMPLETED
|
9
|
9
|
|
Phase I
NOT COMPLETED
|
1
|
1
|
|
Phase II
STARTED
|
9
|
9
|
|
Phase II
COMPLETED
|
9
|
9
|
|
Phase II
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
NewGait/Control
Participants will put on the NewGait device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training.
NewGait: wearable limb orthotic device
Following this, participants will put on the Control device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training.
Control wearable limb orthotic device: wearable limb orthotic device
|
Control/NewGait
Participants will put on the Control device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training.
Control wearable limb orthotic device: wearable limb orthotic device
Following this, participants will put on the NewGait device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training.
NewGait: wearable limb orthotic device
|
|---|---|---|
|
Phase I
Unable to perform study procedures
|
0
|
1
|
|
Phase I
Could not continue study for personal reasons.
|
1
|
0
|
Baseline Characteristics
NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations)
Baseline characteristics by cohort
| Measure |
NewGait/Control
n=10 Participants
Participants will put on the NewGait device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training.
NewGait: wearable limb orthotic device
Following this, participants will put on the Control device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training.
Control wearable limb orthotic device: wearable limb orthotic device
|
Control/NewGait
n=10 Participants
Participants will put on the Control device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training.
Control wearable limb orthotic device: wearable limb orthotic device
Following this, participants will put on the NewGait device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training.
NewGait: wearable limb orthotic device
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 7.8 • n=68 Participants
|
64.6 years
STANDARD_DEVIATION 7.2 • n=4 Participants
|
64.1 years
STANDARD_DEVIATION 7.3 • n=219 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=68 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=219 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=68 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=219 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=68 Participants
|
10 Participants
n=4 Participants
|
20 Participants
n=219 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=68 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=219 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=68 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=219 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
|
Mini-mental state examination score
|
28.9 units on a scale
STANDARD_DEVIATION 1.9 • n=68 Participants
|
28.0 units on a scale
STANDARD_DEVIATION 1.9 • n=4 Participants
|
28.5 units on a scale
STANDARD_DEVIATION 1.9 • n=219 Participants
|
|
Time since stroke
|
102.3 months
STANDARD_DEVIATION 47.8 • n=68 Participants
|
136.2 months
STANDARD_DEVIATION 94.9 • n=4 Participants
|
119.3 months
STANDARD_DEVIATION 75.2 • n=219 Participants
|
|
Lower extremity Fugl-Meyer score
|
21.8 units on a scale
STANDARD_DEVIATION 3.4 • n=68 Participants
|
22.3 units on a scale
STANDARD_DEVIATION 4.3 • n=4 Participants
|
22.1 units on a scale
STANDARD_DEVIATION 3.8 • n=219 Participants
|
|
Gait speed
|
0.9 meters per second
STANDARD_DEVIATION 0.4 • n=68 Participants
|
0.9 meters per second
STANDARD_DEVIATION 0.3 • n=4 Participants
|
0.9 meters per second
STANDARD_DEVIATION 0.4 • n=219 Participants
|
PRIMARY outcome
Timeframe: Up to 2 hoursPopulation: Data was only analyzed on participants who completed the study.
Changes in gait speed (from baseline) as measured using the 10 Meter Walk Test between the experimental (NewGait) and control conditions. Participants were timed during the 10 Meter Walk Test to determine their self-selected gait speed while walking overground in a hallway. In this test, participants walked down a 14 meter walkway, and a stopwatch was used to time how long it took participants to cross the intermediate 10 meter distance. The baseline measure for the first device was taken immediately prior to the intervention. Participants then wore the first device, and the during-training measure was taken immediately. After this, participants received training with the device for about 15 minutes, following which, the device was removed and the post-intervention measure was taken immediately for the first device. Participants then rested for 20-30 minutes. This entire process was repeated with the second device. All measures were obtained on the same day.
Outcome measures
| Measure |
Control
n=18 Participants
Participants will put on the Control device and walk on the treadmill and over ground. Participants may receive biofeedback of their gait patterns to engage them in the training.
Control wearable limb orthotic device: wearable limb orthotic device
|
NewGait
n=18 Participants
Participants will put on the NewGait device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training.
NewGait: wearable limb orthotic device
|
|---|---|---|
|
Gait Speed
Baseline
|
0.92 meters per second
Standard Error 0.08
|
0.90 meters per second
Standard Error 0.09
|
|
Gait Speed
During training
|
0.87 meters per second
Standard Error 0.08
|
0.88 meters per second
Standard Error 0.08
|
|
Gait Speed
Post-intervention
|
0.92 meters per second
Standard Error 0.09
|
0.91 meters per second
Standard Error 0.09
|
PRIMARY outcome
Timeframe: Up to 2 hoursPopulation: Data was only analyzed on participants who completed the study.
Changes in ankle muscle activation of the leg muscles as measured using surface electromyography between the experimental (NewGait) and control conditions. Muscle activation ranges from 0 to no upper limit, and higher activation meant that the muscle was being used more. The baseline measure for the first device was taken immediately prior to the intervention. Participants then wore the first device, and the during-training measure was taken immediately. After this, participants received training with the device for about 15 minutes, following which, the device was removed, and the post-intervention measure was taken immediately for the first device. Participants then rested for 20-30 minutes. This entire process was repeated with the second device. All measures were obtained on the same day.
Outcome measures
| Measure |
Control
n=18 Participants
Participants will put on the Control device and walk on the treadmill and over ground. Participants may receive biofeedback of their gait patterns to engage them in the training.
Control wearable limb orthotic device: wearable limb orthotic device
|
NewGait
n=18 Participants
Participants will put on the NewGait device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training.
NewGait: wearable limb orthotic device
|
|---|---|---|
|
Ankle Muscle Activation
Medial Gastrocnemius, Baseline
|
72.98 percentage of maximum muscle activation
Standard Error 15.68
|
75.29 percentage of maximum muscle activation
Standard Error 15.68
|
|
Ankle Muscle Activation
Medial Gastrocnemius, During training
|
66.77 percentage of maximum muscle activation
Standard Error 15.05
|
62.41 percentage of maximum muscle activation
Standard Error 14.61
|
|
Ankle Muscle Activation
Medial Gastrocnemius, Post-intervention
|
75.46 percentage of maximum muscle activation
Standard Error 15.12
|
67.77 percentage of maximum muscle activation
Standard Error 15.26
|
|
Ankle Muscle Activation
Lateral Soleus, Baseline
|
68.43 percentage of maximum muscle activation
Standard Error 14.41
|
68.61 percentage of maximum muscle activation
Standard Error 14.78
|
|
Ankle Muscle Activation
Lateral Soleus, During training
|
72.24 percentage of maximum muscle activation
Standard Error 13.49
|
72.72 percentage of maximum muscle activation
Standard Error 14.22
|
|
Ankle Muscle Activation
Lateral Soleus, Post-intervention
|
64.05 percentage of maximum muscle activation
Standard Error 15.99
|
68.66 percentage of maximum muscle activation
Standard Error 15.99
|
|
Ankle Muscle Activation
Tibialis Anterior, Baseline
|
30.08 percentage of maximum muscle activation
Standard Error 3.83
|
30.87 percentage of maximum muscle activation
Standard Error 2.93
|
|
Ankle Muscle Activation
Tibialis Anterior, During training
|
21.55 percentage of maximum muscle activation
Standard Error 3.87
|
28.04 percentage of maximum muscle activation
Standard Error 3.87
|
|
Ankle Muscle Activation
Tibialis Anterior, Post-intervention
|
30.02 percentage of maximum muscle activation
Standard Error 3.02
|
25.71 percentage of maximum muscle activation
Standard Error 4.04
|
SECONDARY outcome
Timeframe: Up to 2 hoursPopulation: Data was only analyzed on participants who completed the study.
Changes in paretic leg propulsive force were measured using ground reaction forces obtained from force sensors during walking between the experimental (NewGait) and control conditions. Propulsive force had no upper or lower limit, with a higher number indicating greater propulsion from the paretic limb. The baseline measure for the first device was taken immediately prior to the intervention. Participants then wore the first device, and the during-training measure was taken immediately. After this, participants received training with the device for about 15 minutes, following which, the device was removed, and the post-intervention measure was taken immediately for the first device. Participants then rested for 20-30 minutes. This entire process was repeated with the second device. Results reflect Newton units in force generated divided by Newton units of body weight (N/N) times 100. All measures were obtained on the same day.
Outcome measures
| Measure |
Control
n=18 Participants
Participants will put on the Control device and walk on the treadmill and over ground. Participants may receive biofeedback of their gait patterns to engage them in the training.
Control wearable limb orthotic device: wearable limb orthotic device
|
NewGait
n=18 Participants
Participants will put on the NewGait device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training.
NewGait: wearable limb orthotic device
|
|---|---|---|
|
Changes in Paretic Leg Propulsive Force
Baseline
|
8.03 percentage of body weight (N/N)
Standard Error 1.26
|
8.22 percentage of body weight (N/N)
Standard Error 1.26
|
|
Changes in Paretic Leg Propulsive Force
During training
|
11.36 percentage of body weight (N/N)
Standard Error 1.86
|
11.92 percentage of body weight (N/N)
Standard Error 1.86
|
|
Changes in Paretic Leg Propulsive Force
Post-intervention
|
9.00 percentage of body weight (N/N)
Standard Error 1.31
|
8.70 percentage of body weight (N/N)
Standard Error 1.31
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 hoursChanges in paretic leg loading were measured using vertical ground reaction forces obtained from force sensors during walking between the experimental (NewGait) and control conditions.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 hoursChanges in lower extremity muscle activation as measured using surface electromyography between the experimental (NewGait) and control conditions.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 hoursChanges in ankle muscle coordination of the leg muscles as measured using surface electromyography between the experimental (NewGait) and control conditions.
Outcome measures
Outcome data not reported
Adverse Events
NewGait
Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NewGait
n=20 participants at risk
Participants will put on the NewGait device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training.
NewGait: wearable limb orthotic device
|
Control
n=20 participants at risk
Participants will put on the Control device and walk on the treadmill and over ground. Participants may receive biofeedback of their gait patterns to engage them in the training.
Control wearable limb orthotic device: wearable limb orthotic device
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
20.0%
4/20 • Up to 2 hours
|
20.0%
4/20 • Up to 2 hours
|
|
Musculoskeletal and connective tissue disorders
Muscle/Joint Pain
|
20.0%
4/20 • Up to 2 hours
|
20.0%
4/20 • Up to 2 hours
|
|
Musculoskeletal and connective tissue disorders
Fatigue
|
45.0%
9/20 • Up to 2 hours
|
45.0%
9/20 • Up to 2 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place