Gait, Hemiplegic Clinical Trial
Official title:
Innovative Biofeedback Strategies for Gait Training
Verified date | May 2019 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The long-term study goal is to develop a more engaging, motivating gait biofeedback methodologies specifically designed for post-stroke gait training. The current project aims to address fundamental questions regarding the optimal methodology to deliver AGRF biofeedback during gait, and the feasibility and preliminary efficacy of AGRF progression protocols for improved gait patterns and gait function. The study objectives are to (1) evaluate the immediate effects of biofeedback training methodology on gait biomechanics; and (2) evaluate the feasibility and short-term effects on gait performance of a real-time biofeedback protocol incorporating progression criteria (similar to those employed during clinical rehabilitative training).
Status | Completed |
Enrollment | 20 |
Est. completion date | October 3, 2018 |
Est. primary completion date | October 3, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: Stroke participants: - age 30-90 years (stroke) or 18-50 years (able-bodied controls) - chronic stroke (>6 months post stroke) - 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 Able-bodied participants: - age 18 to 50 years - no history of neurologic disease - no history of orthopedic disease or injury affecting the lower extremity. Exclusion Criteria: 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. Able-bodied controls - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Emory Univeristy | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
Genthe K, Schenck C, Eicholtz S, Zajac-Cox L, Wolf S, Kesar TM. Effects of real-time gait biofeedback on paretic propulsion and gait biomechanics in individuals post-stroke. Top Stroke Rehabil. 2018 Apr;25(3):186-193. doi: 10.1080/10749357.2018.1436384. Epub 2018 Feb 19. — View Citation
Schenck C, Kesar TM. Effects of unilateral real-time biofeedback on propulsive forces during gait. J Neuroeng Rehabil. 2017 Jun 6;14(1):52. doi: 10.1186/s12984-017-0252-z. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | paretic pushoff (AGRF) | peak GRF generated by the leg affected by the stroke | Immediately after the 6-minute biofeedback training bout (Post-0 minutes) | |
Secondary | non-paretic peak AGRF | peak GRF generated by the leg not affected by the stroke | Immediately after the 6-minute biofeedback training bout (Post-0 minutes) | |
Secondary | paretic trailing limb angle | angle measuring limb orientation with respect to vertical at terminal stance | Immediately after the 6-minute biofeedback training bout (Post-0 minutes) |
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