Gait, Hemiplegic, Stroke
Conditions
Keywords
stroke, gait rehabilitation, game
Brief summary
This study will conduct a preliminary evaluation of and obtain user data on a novel game-based visual interface for stroke gait training. Study participants will complete one session comprising exposure to gait biofeedback systems in an order determined by randomization. Participants will be exposed to 2 types of biofeedback interfaces: * newly developed game-based interface (projector screen display) * traditional, non-game interface
Detailed description
Stroke is the leading cause of adult disability. Even after discharge from rehabilitation, residual gait deficits are prevalent in stroke survivors, leading to decreased walking speed and endurance. Because gait dysfunctions limit community mobility, stroke survivors and rehabilitation clinicians consider restoration of walking a major goal of rehabilitation. Several challenges and research gaps limit the effectiveness of current clinical gait rehabilitation practices. While there is consensus that stroke survivors benefit from gait rehabilitation, agreement is lacking on which specific training interventions are most efficacious. The long-term goal of this proposal is to address these challenges by developing personalized, engaging, salient gait training treatments founded on evidence from neuroscience, biomechanics, motor learning, and gaming. Real-time biofeedback is a promising gait training intervention for targeting specific biomechanical impairments. Biofeedback can enhance an individual's awareness of the impairment targeted during gait training, enabling self-correction of aberrant gait patterns. In response to treadmill training combined with visual and auditory real-time biofeedback, able-bodied individuals can increase anterior ground reaction forces (AGRF) unilaterally for the targeted limb. Thus, AGRF biofeedback may be a beneficial strategy to target unilateral propulsive deficits in people post-stroke. Incorporation of gaming interfaces for gait biofeedback can increase patient motivation, distract participants from fatigue or boredom, and encourage greater numbers of repetitions during gait training. The long-term goal of this study is to develop a more engaging, motivating gait biofeedback methodologies specifically designed for post-stroke gait training. The researchers aim to address a major challenge for rehabilitation clinicians - to make gait training appealing and meaningful so that patients engage in sufficient repetitions, intensity, and challenge to maximize therapeutic effectiveness. The study premise is that post-stroke individuals will demonstrate greater engagement, motivation, and therapeutic benefits during gait training sessions involving biofeedback when training incorporates intuitive, entertaining, game-based interfaces. Outcomes of the study will include measures of participant engagement, user-reports and survey-responses on motivation, fatigue, game characteristics, and adverse effects (e.g. nausea, dizziness) during game exposure. In addition to this clinical trial with stroke survivor participants, data about the game interface will be collected by having able-bodied neuro-rehabilitation clinicians try the 2 types of biofeedback interventions. Study participants will complete one sessions comprising exposure to gait biofeedback systems in a randomized order. Participants will be exposed to 2 types of biofeedback interfaces: (i) newly developed game-based interface (projector screen display), and (ii) traditional, non-game interface.
Interventions
OTHERAGRF Biofeedback Game
During the AGRF biofeedback game participants will walk on a split-belt treadmill with a projector or screen display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game for 4 minutes.
OTHERTraditional 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 will be exposed to the traditional biofeedback interface for 4 minutes.
OTHERControl Condition
Participants will complete a control walk with out feedback.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Emory University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
The study outcomes will comprise objective biomechanical measures derived using motion capture, which will be processed by lab personnel who are blinded to the gait training condition.
Intervention model description
This study aims to enroll 12 post-stroke and 12 able-bodied individuals who will complete gait trials with 2 different biofeedback interfaces in each experimental session.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
for Post-Stroke Participants: * age 30 to 90 years * chronic stroke (\>6 months post stroke) affecting the right leg * ambulatory with or without the use of a cane or walker * able to walk for 2 minutes at the self-selected speed without an orthoses * resting heart rate 40-100 beats per minute
Exclusion criteria
for Post-Stroke Participants: * cerebellar signs (ataxic (drunken) gait or decreased coordination during rapid alternating hand or foot movements) * history of lower extremity joint replacement * inability to communicate with investigators * neglect/hemianopia, or unexplained dizziness in last 6 months * neurologic conditions other than stroke * orthopedic problems in the lower limbs or spine (or other medical conditions) that limit walking or cause pain during walking Inclusion Criteria for Able-bodied Participants: * age 18 to 90 years * no history of neurologic disease * no history of orthopedic disease or injury affecting the lower extremity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak AGRF | After each biofeedback interface session on Day 1 | 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. |
| Trailing Limb Angle (TLA) | After each biofeedback interface session on Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NASA Task Load Index (NASA - TLX) | Day 1, after each of the biofeedback interface sessions | The 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. |
| Likert Enjoyment/Boredom Scale Domain Scores | Day 1, after each of the biofeedback interface sessions | The 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. |
| Borg Rating of Perceived Exertion (RPE) Scale | Day 1, during each of the biofeedback interface sessions | The 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. |
| User Evaluation Questionnaire (UEQ) Score | Day 1, after each of the biofeedback sessions | User 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | Day 1, during and after each of the biofeedback sessions | Participants 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. |
| Qualitative Feedback | Day 1, after each of the biofeedback sessions | User experiences about the feedback will be obtained in the form of subjective comments. |
| Skin Impedance | Day 1, during each of the biofeedback sessions | A 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| 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. | 9 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Missing biomechanical data | 0 | 1 |
| Overall Study | Treadmill speed less than 0.50 miles per hour | 2 | 0 |
Baseline characteristics
| Characteristic | Post-stroke Participants | Total | Able-bodied Participants |
|---|---|---|---|
| Age, Continuous | 63.43 years STANDARD_DEVIATION 7.46 | 43.44 years STANDARD_DEVIATION 19.05 | 27.89 years STANDARD_DEVIATION 4.14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 15 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 10 Participants | 5 Participants |
| Region of Enrollment United States | 7 Participants | 16 Participants | 9 Participants |
| Sex: Female, Male Female | 3 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 10 |
| other Total, other adverse events | 0 / 9 | 0 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 10 |
Outcome results
Primary
Peak AGRF
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.
Time frame: After each biofeedback interface session on Day 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Post-stroke Participants | Peak AGRF | Traditional Biofeedback Interface | 99.1 Newtons | Standard Deviation 23.5 |
| Post-stroke Participants | Peak AGRF | AGRF Biofeedback Game | 95.6 Newtons | Standard Deviation 29.9 |
| Able-bodied Participants | Peak AGRF | Traditional Biofeedback Interface | 143.8 Newtons | Standard Deviation 62.1 |
| Able-bodied Participants | Peak AGRF | AGRF Biofeedback Game | 166.6 Newtons | Standard Deviation 67.4 |
Primary
Trailing Limb Angle (TLA)
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.
Time frame: After each biofeedback interface session on Day 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Post-stroke Participants | Trailing Limb Angle (TLA) | Traditional Biofeedback Interface | 19.56 degrees | Standard Deviation 2.95 |
| Post-stroke Participants | Trailing Limb Angle (TLA) | AGRF Biofeedback Interface | 18.63 degrees | Standard Deviation 2.69 |
| Able-bodied Participants | Trailing Limb Angle (TLA) | Traditional Biofeedback Interface | 22.52 degrees | Standard Deviation 3.06 |
| Able-bodied Participants | Trailing Limb Angle (TLA) | AGRF Biofeedback Interface | 24.22 degrees | Standard Deviation 4.3 |
Secondary
Borg Rating of Perceived Exertion (RPE) Scale
The 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.
Time frame: Day 1, during each of the biofeedback interface sessions
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Post-stroke Participants | Borg Rating of Perceived Exertion (RPE) Scale | AGRF Biofeedback Game | 10.43 units on a scale | Standard Deviation 2.99 |
| Post-stroke Participants | Borg Rating of Perceived Exertion (RPE) Scale | Traditional Biofeedback Interface | 10.29 units on a scale | Standard Deviation 2.14 |
| Able-bodied Participants | Borg Rating of Perceived Exertion (RPE) Scale | Traditional Biofeedback Interface | 8.67 units on a scale | Standard Deviation 1.22 |
| Able-bodied Participants | Borg Rating of Perceived Exertion (RPE) Scale | AGRF Biofeedback Game | 10.11 units on a scale | Standard Deviation 3.33 |
Secondary
Likert Enjoyment/Boredom Scale Domain Scores
The 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.
Time frame: Day 1, after each of the biofeedback interface sessions
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Post-stroke Participants | Likert Enjoyment/Boredom Scale Domain Scores | Enjoyment/Fun Domain Score for AGRF Biofeedback Game | 6.29 score on a scale | Standard Deviation 0.95 |
| Post-stroke Participants | Likert Enjoyment/Boredom Scale Domain Scores | Motivation Domain Score for AGRF Biofeedback Game | 6.71 score on a scale | Standard Deviation 1.11 |
| Post-stroke Participants | Likert Enjoyment/Boredom Scale Domain Scores | Boredom Domain Score for AGRF Biofeedback Game | 5.57 score on a scale | Standard Deviation 2.37 |
| Post-stroke Participants | Likert Enjoyment/Boredom Scale Domain Scores | Challenge Domain Score for Traditional Biofeedback Interface | 5.71 score on a scale | Standard Deviation 1.5 |
| Post-stroke Participants | Likert Enjoyment/Boredom Scale Domain Scores | Boredom Domain Score for Traditional Biofeedback Interface | 6.57 score on a scale | Standard Deviation 2.3 |
| Post-stroke Participants | Likert Enjoyment/Boredom Scale Domain Scores | Challenge Domain Score for AGRF Biofeedback Game | 6.86 score on a scale | Standard Deviation 1.07 |
| Post-stroke Participants | Likert Enjoyment/Boredom Scale Domain Scores | Motivation Domain Score for Traditional Biofeedback Interface | 6.86 score on a scale | Standard Deviation 1.21 |
| Post-stroke Participants | Likert Enjoyment/Boredom Scale Domain Scores | Enjoyment/Fun Domain Score for Traditional Biofeedback Interface | 5.57 score on a scale | Standard Deviation 1.62 |
| Able-bodied Participants | Likert Enjoyment/Boredom Scale Domain Scores | Enjoyment/Fun Domain Score for AGRF Biofeedback Game | 5.78 score on a scale | Standard Deviation 0.97 |
| Able-bodied Participants | Likert Enjoyment/Boredom Scale Domain Scores | Enjoyment/Fun Domain Score for Traditional Biofeedback Interface | 4.78 score on a scale | Standard Deviation 2.33 |
| Able-bodied Participants | Likert Enjoyment/Boredom Scale Domain Scores | Boredom Domain Score for Traditional Biofeedback Interface | 5.22 score on a scale | Standard Deviation 2.33 |
| Able-bodied Participants | Likert Enjoyment/Boredom Scale Domain Scores | Boredom Domain Score for AGRF Biofeedback Game | 6.56 score on a scale | Standard Deviation 1.67 |
| Able-bodied Participants | Likert Enjoyment/Boredom Scale Domain Scores | Motivation Domain Score for Traditional Biofeedback Interface | 6.33 score on a scale | Standard Deviation 1.41 |
| Able-bodied Participants | Likert Enjoyment/Boredom Scale Domain Scores | Motivation Domain Score for AGRF Biofeedback Game | 6.22 score on a scale | Standard Deviation 1.79 |
| Able-bodied Participants | Likert Enjoyment/Boredom Scale Domain Scores | Challenge Domain Score for Traditional Biofeedback Interface | 4.11 score on a scale | Standard Deviation 1.36 |
| Able-bodied Participants | Likert Enjoyment/Boredom Scale Domain Scores | Challenge Domain Score for AGRF Biofeedback Game | 6.00 score on a scale | Standard Deviation 1.73 |
Secondary
NASA Task Load Index (NASA - TLX)
The 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.
Time frame: Day 1, after each of the biofeedback interface sessions
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Post-stroke Participants | NASA Task Load Index (NASA - TLX) | Traditional Biofeedback Interface | 7.98 score on a scale | Standard Deviation 1.87 |
| Post-stroke Participants | NASA Task Load Index (NASA - TLX) | AGRF Biofeedback Game | 9.76 score on a scale | Standard Deviation 2.75 |
| Able-bodied Participants | NASA Task Load Index (NASA - TLX) | Traditional Biofeedback Interface | 6.89 score on a scale | Standard Deviation 2.02 |
| Able-bodied Participants | NASA Task Load Index (NASA - TLX) | AGRF Biofeedback Game | 10.83 score on a scale | Standard Deviation 2.95 |
Secondary
User Evaluation Questionnaire (UEQ) Score
User 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.
Time frame: Day 1, after each of the biofeedback sessions
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Post-stroke Participants | 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 |
| Post-stroke Participants | User Evaluation Questionnaire (UEQ) Score | AGRF Biofeedback Game - Items Where High Score Value Indicates Positive Perceptions | 5.36 score on a scale | Standard Deviation 1.2 |
| Post-stroke Participants | 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 |
| Post-stroke Participants | 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 |
| Able-bodied Participants | User Evaluation Questionnaire (UEQ) Score | AGRF Biofeedback Game - Items Where Low Score Value Indicates Positive Perceptions | 2.38 score on a scale | Standard Deviation 0.66 |
| Able-bodied Participants | User Evaluation Questionnaire (UEQ) Score | Traditional Biofeedback Interface -Items Where High Score Value Indicates Positive Perceptions | 5.19 score on a scale | Standard Deviation 0.73 |
| Able-bodied Participants | User Evaluation Questionnaire (UEQ) Score | Traditional Biofeedback Interface -Items Where Low Score Value Indicates Positive Perceptions | 2.69 score on a scale | Standard Deviation 0.65 |
| Able-bodied Participants | User Evaluation Questionnaire (UEQ) Score | AGRF Biofeedback Game - Items Where High Score Value Indicates Positive Perceptions | 5.41 score on a scale | Standard Deviation 0.71 |
Other Pre-specified
Heart Rate
Participants 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.
Time frame: Day 1, during and after each of the biofeedback sessions
Other Pre-specified
Qualitative Feedback
User experiences about the feedback will be obtained in the form of subjective comments.
Time frame: Day 1, after each of the biofeedback sessions
Other Pre-specified
Skin Impedance
A 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.
Time frame: Day 1, during each of the biofeedback sessions