Trial Outcomes & Findings for Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation (NCT NCT04013971)
NCT ID: NCT04013971
Last Updated: 2025-04-25
Results Overview
Paretic leg (right leg for post-stroke participants) or targeted leg (right leg for able-bodied participants) peak push off force (peak AGRF) was calculated from GRF data. Higher values indicate greater push off force.
COMPLETED
NA
19 participants
After each biofeedback interface session on Day 1
2025-04-25
Participant Flow
Participant milestones
| Measure |
Post-stroke Participants
Post-stroke participants completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided.
AGRF Biofeedback Game: During the AGRF biofeedback game participants walk on a split-belt treadmill with a projector or screen display. Participants receive real-time information or feedback about ongoing gait performance parameters while they are walking. The participants are exposed to the AGRF biofeedback game for 4 minutes.
Traditional Biofeedback Interface: For the traditional non-game biofeedback, the visual display comprises a horizontal line graph with a moveable cursor that represents the current measured value of antero-posterior ground reaction force for the targeted leg. The auditory feedback comprises an audible "beep" produced every time the cursor entered the target range. Participants are exposed to the traditional biofeedback interface for 4 minutes.
Control Condition: Participants complete a control walk with out feedback.
|
Able-bodied Participants
Able-bodied individuals completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided.
AGRF Biofeedback Game: During the AGRF biofeedback game participants walk on a split-belt treadmill with a projector or screen display. Participants receive real-time information or feedback about ongoing gait performance parameters while they are walking. The participants are exposed to the AGRF biofeedback game for 4 minutes.
Traditional Biofeedback Interface: For the traditional non-game biofeedback, the visual display comprises a horizontal line graph with a moveable cursor that represents the current measured value of antero-posterior ground reaction force for the targeted leg. The auditory feedback comprises an audible "beep" produced every time the cursor entered the target range. Participants are exposed to the traditional biofeedback interface for 4 minutes.
Control Condition: Participants complete a control walk with out feedback.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Post-stroke Participants
Post-stroke participants completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided.
AGRF Biofeedback Game: During the AGRF biofeedback game participants walk on a split-belt treadmill with a projector or screen display. Participants receive real-time information or feedback about ongoing gait performance parameters while they are walking. The participants are exposed to the AGRF biofeedback game for 4 minutes.
Traditional Biofeedback Interface: For the traditional non-game biofeedback, the visual display comprises a horizontal line graph with a moveable cursor that represents the current measured value of antero-posterior ground reaction force for the targeted leg. The auditory feedback comprises an audible "beep" produced every time the cursor entered the target range. Participants are exposed to the traditional biofeedback interface for 4 minutes.
Control Condition: Participants complete a control walk with out feedback.
|
Able-bodied Participants
Able-bodied individuals completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided.
AGRF Biofeedback Game: During the AGRF biofeedback game participants walk on a split-belt treadmill with a projector or screen display. Participants receive real-time information or feedback about ongoing gait performance parameters while they are walking. The participants are exposed to the AGRF biofeedback game for 4 minutes.
Traditional Biofeedback Interface: For the traditional non-game biofeedback, the visual display comprises a horizontal line graph with a moveable cursor that represents the current measured value of antero-posterior ground reaction force for the targeted leg. The auditory feedback comprises an audible "beep" produced every time the cursor entered the target range. Participants are exposed to the traditional biofeedback interface for 4 minutes.
Control Condition: Participants complete a control walk with out feedback.
|
|---|---|---|
|
Overall Study
Treadmill speed less than 0.50 miles per hour
|
2
|
0
|
|
Overall Study
Missing biomechanical data
|
0
|
1
|
Baseline Characteristics
Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation
Baseline characteristics by cohort
| Measure |
Post-stroke Participants
n=7 Participants
Post-stroke participants completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided.
|
Able-bodied Participants
n=9 Participants
Able-bodied individuals completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.43 years
STANDARD_DEVIATION 7.46 • n=5 Participants
|
27.89 years
STANDARD_DEVIATION 4.14 • n=7 Participants
|
43.44 years
STANDARD_DEVIATION 19.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After each biofeedback interface session on Day 1Population: This analysis includes participants who completed the trial and had the right leg studied. One post-stroke participant had their left side affected and was not included in this analysis.
Paretic leg (right leg for post-stroke participants) or targeted leg (right leg for able-bodied participants) peak push off force (peak AGRF) was calculated from GRF data. Higher values indicate greater push off force.
Outcome measures
| Measure |
Post-stroke Participants
n=6 Participants
Post-stroke participants completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided.
|
Able-bodied Participants
n=9 Participants
Able-bodied individuals completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided.
|
|---|---|---|
|
Peak AGRF
Traditional Biofeedback Interface
|
99.1 Newtons
Standard Deviation 23.5
|
143.8 Newtons
Standard Deviation 62.1
|
|
Peak AGRF
AGRF Biofeedback Game
|
95.6 Newtons
Standard Deviation 29.9
|
166.6 Newtons
Standard Deviation 67.4
|
PRIMARY outcome
Timeframe: After each biofeedback interface session on Day 1Population: This analysis includes participants who completed the trial and had the right leg studied. One post-stroke participant had their left side affected and was not included in this analysis.
The trailing limb angle contributes to increased propulsion during walking. Trailing limb angle is a kinematic variable derived from 3-dimensional motion capture, which measures the orientation of the leg with respect to the center of mass at the stance to swing transition. In stroke survivors, trailing limb angle increases as walking speed increases.
Outcome measures
| Measure |
Post-stroke Participants
n=6 Participants
Post-stroke participants completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided.
|
Able-bodied Participants
n=9 Participants
Able-bodied individuals completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided.
|
|---|---|---|
|
Trailing Limb Angle (TLA)
Traditional Biofeedback Interface
|
19.56 degrees
Standard Deviation 2.95
|
22.52 degrees
Standard Deviation 3.06
|
|
Trailing Limb Angle (TLA)
AGRF Biofeedback Interface
|
18.63 degrees
Standard Deviation 2.69
|
24.22 degrees
Standard Deviation 4.30
|
SECONDARY outcome
Timeframe: Day 1, after each of the biofeedback interface sessionsThe Likert Enjoyment Boredom Scale is a 4-item instrument evaluating user reports of perceived effort in four different domains: Enjoyment/Fun, Boredom, Motivation, and Challenge. To assess each domain, participants are asked: * How much enjoyment/fun did you feel in the previous walking trial? * How much boredom did you feel in the previous walking trial? * How much motivation did you feel in the previous walking trial? * How much challenge did you feel in the previous walking trial? Each question is scored on a 8-point scale from 1 to 8, where the intensity of each domain is scored as 1 = not at all to 8 = very much/a lot. For the individual domains, higher scores are interpreted as the participant experiencing greater enjoyment/fun, boredom, motivation, or challenge.
Outcome measures
| Measure |
Post-stroke Participants
n=7 Participants
Post-stroke participants completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided.
|
Able-bodied Participants
n=9 Participants
Able-bodied individuals completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided.
|
|---|---|---|
|
Likert Enjoyment/Boredom Scale Domain Scores
Enjoyment/Fun Domain Score for Traditional Biofeedback Interface
|
5.57 score on a scale
Standard Deviation 1.62
|
4.78 score on a scale
Standard Deviation 2.33
|
|
Likert Enjoyment/Boredom Scale Domain Scores
Enjoyment/Fun Domain Score for AGRF Biofeedback Game
|
6.29 score on a scale
Standard Deviation 0.95
|
5.78 score on a scale
Standard Deviation 0.97
|
|
Likert Enjoyment/Boredom Scale Domain Scores
Boredom Domain Score for Traditional Biofeedback Interface
|
6.57 score on a scale
Standard Deviation 2.30
|
5.22 score on a scale
Standard Deviation 2.33
|
|
Likert Enjoyment/Boredom Scale Domain Scores
Boredom Domain Score for AGRF Biofeedback Game
|
5.57 score on a scale
Standard Deviation 2.37
|
6.56 score on a scale
Standard Deviation 1.67
|
|
Likert Enjoyment/Boredom Scale Domain Scores
Motivation Domain Score for Traditional Biofeedback Interface
|
6.86 score on a scale
Standard Deviation 1.21
|
6.33 score on a scale
Standard Deviation 1.41
|
|
Likert Enjoyment/Boredom Scale Domain Scores
Motivation Domain Score for AGRF Biofeedback Game
|
6.71 score on a scale
Standard Deviation 1.11
|
6.22 score on a scale
Standard Deviation 1.79
|
|
Likert Enjoyment/Boredom Scale Domain Scores
Challenge Domain Score for Traditional Biofeedback Interface
|
5.71 score on a scale
Standard Deviation 1.50
|
4.11 score on a scale
Standard Deviation 1.36
|
|
Likert Enjoyment/Boredom Scale Domain Scores
Challenge Domain Score for AGRF Biofeedback Game
|
6.86 score on a scale
Standard Deviation 1.07
|
6.00 score on a scale
Standard Deviation 1.73
|
SECONDARY outcome
Timeframe: Day 1, after each of the biofeedback interface sessionsThe NASA task load index (NASA - TLX) evaluates user reports of perceived effort in six subscales of Mental Demand, Physical Demand, Temporal Demand, Performance, Effort, and Frustration. Each subscale is scored on a 21-point scale from 1 to 21, where very low demand/perfect performance = 1 and very high demand/failure = 21. A total score is created by taking the average of each subscale; the total score ranges from 1 to 21 with higher scores indicating that the task is very demanding to perform.
Outcome measures
| Measure |
Post-stroke Participants
n=7 Participants
Post-stroke participants completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided.
|
Able-bodied Participants
n=9 Participants
Able-bodied individuals completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided.
|
|---|---|---|
|
NASA Task Load Index (NASA - TLX)
Traditional Biofeedback Interface
|
7.98 score on a scale
Standard Deviation 1.87
|
6.89 score on a scale
Standard Deviation 2.02
|
|
NASA Task Load Index (NASA - TLX)
AGRF Biofeedback Game
|
9.76 score on a scale
Standard Deviation 2.75
|
10.83 score on a scale
Standard Deviation 2.95
|
SECONDARY outcome
Timeframe: Day 1, during each of the biofeedback interface sessionsThe Borg Rating of Perceived Exertion (RPE) Scale asks respondents to report how hard it feels like their body is working with a single item. Perceived exertion is rated on a scale from 6 to 20 where "no exertion at all" is scored as 6 and "maximal exertion" is scored as 20. Ratings between 12 and 14 are generally considered as a moderate intensity level.
Outcome measures
| Measure |
Post-stroke Participants
n=7 Participants
Post-stroke participants completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided.
|
Able-bodied Participants
n=9 Participants
Able-bodied individuals completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided.
|
|---|---|---|
|
Borg Rating of Perceived Exertion (RPE) Scale
Traditional Biofeedback Interface
|
10.29 units on a scale
Standard Deviation 2.14
|
8.67 units on a scale
Standard Deviation 1.22
|
|
Borg Rating of Perceived Exertion (RPE) Scale
AGRF Biofeedback Game
|
10.43 units on a scale
Standard Deviation 2.99
|
10.11 units on a scale
Standard Deviation 3.33
|
SECONDARY outcome
Timeframe: Day 1, after each of the biofeedback sessionsUser experience of the biofeedback game is assessed with a 26-item user evaluation questionnaire (UEQ). Participants indicate how they found the session to be for a variety of usability qualities, including likability, speed, and meeting expectations. Responses are given on a 7-point scale where scale where 1 = the most agreement with the adjective on the left, 4 = a neutral response, and 7 = the most agreement with the adjective on the right. For some items high scores are associated with positive perceptions, while for other items low low scores are associated with positive perceptions. Items were grouped according to whether high or low scores meant positive perceptions and separate summary scores were obtained by calculating the mean score for the items included, so that the summary scores range from t to 7.
Outcome measures
| Measure |
Post-stroke Participants
n=7 Participants
Post-stroke participants completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided.
|
Able-bodied Participants
n=9 Participants
Able-bodied individuals completing gait training trials with two different biofeedback interfaces in each experimental session. Participants also complete a control condition where no biofeedback is provided.
|
|---|---|---|
|
User Evaluation Questionnaire (UEQ) Score
Traditional Biofeedback Interface -Items Where High Score Value Indicates Positive Perceptions
|
5.46 score on a scale
Standard Deviation 0.75
|
5.19 score on a scale
Standard Deviation 0.73
|
|
User Evaluation Questionnaire (UEQ) Score
AGRF Biofeedback Game - Items Where High Score Value Indicates Positive Perceptions
|
5.36 score on a scale
Standard Deviation 1.20
|
5.41 score on a scale
Standard Deviation 0.71
|
|
User Evaluation Questionnaire (UEQ) Score
Traditional Biofeedback Interface -Items Where Low Score Value Indicates Positive Perceptions
|
2.27 score on a scale
Standard Deviation 0.55
|
2.69 score on a scale
Standard Deviation 0.65
|
|
User Evaluation Questionnaire (UEQ) Score
AGRF Biofeedback Game - Items Where Low Score Value Indicates Positive Perceptions
|
2.36 score on a scale
Standard Deviation 0.87
|
2.38 score on a scale
Standard Deviation 0.66
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, after each of the biofeedback sessionsUser experiences about the feedback will be obtained in the form of subjective comments.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, during and after each of the biofeedback sessionsParticipants wear a heart rate monitor placed on the chest under clothing (Polar USA, Lake Success ,NY) and heart rate is collected after every sixty seconds of walking.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, during each of the biofeedback sessionsA galvanic skin resistance (GSR) device is wrapped around the index and middle finger on the subject's left or right hand ensuring it was not on the bone of the fingers nor tightly wrapped to avoid blood flow restriction. These data are collected for 3 minutes when the subject is presented with the biofeedback interface.
Outcome measures
Outcome data not reported
Adverse Events
Post-stroke Participants
Able-bodied Participants
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