Clinical trial NCT04013971: Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation
Official title: Innovative Biofeedback Interface for Enhancing Stroke Gait Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait, Hemiplegic
Stroke
Keywords: stroke
gait rehabilitation
game
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-07-10
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Exclusion Criteria for Able-bodied Participants:

* history of neurologic disease
* history of orthopedic disease or injury to the lower extremity in the past 6 months
* pain or discomfort during walking
* cardiovascular or medical condition affecting ability to exercise or walk

Primary outcomes:
measure: Peak AGRF
timeFrame: After each biofeedback interface session on Day 1
measure: Trailing Limb Angle (TLA)
timeFrame: After each biofeedback interface session on Day 1
Secondary outcomes:
measure: Likert Enjoyment/Boredom Scale Domain Scores
timeFrame: Day 1, after each of the biofeedback interface sessions
measure: NASA Task Load Index (NASA - TLX)
timeFrame: Day 1, after each of the biofeedback interface sessions
measure: Borg Rating of Perceived Exertion (RPE) Scale
timeFrame: Day 1, during each of the biofeedback interface sessions
measure: User Evaluation Questionnaire (UEQ) Score
timeFrame: Day 1, after each of the biofeedback sessions
Other outcomes:
measure: Qualitative Feedback
timeFrame: Day 1, after each of the biofeedback sessions
measure: Heart Rate
timeFrame: Day 1, during and after each of the biofeedback sessions
measure: Skin Impedance
timeFrame: Day 1, during each of the biofeedback sessions
Locations:
city: Atlanta
country: United States
facility: Emory Rehabilitation Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Trisha Kesar, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: