Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 17, 2020
Date Accepted: Jul 7, 2020
Date Submitted to PubMed: Jul 14, 2020
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Effects of an Overground Walking Program with a Robotic Exoskeleton in Long-Term Manual Wheelchair Users with a Chronic Spinal Cord Injury: Protocol for a Self-Controlled Interventional Study
ABSTRACT
Background:
In wheelchair users with a spinal cord injury (WUSCI), prolonged non-active sitting time and reduced physical activity—typically linked to this mode of mobility—contribute to the development or exacerbation of cardiorespiratory, musculoskeletal, and endocrine-metabolic health complications that are often linked to increased risks of chronic pain or psychological morbidity. Limited evidence suggests that engaging in a walking program with a wearable robotic exoskeleton (WRE) may be a promising physical activity intervention to counter these detrimental health effects.
Objective:
This study’s overall goals are to determine: 1) the effects of a 16-week WRE-assisted walking program on organic systems, functional capacities, and multifaceted psychosocial factors, and 2) self-reported satisfaction and perspectives with regard to the intervention and the device.
Methods:
Twenty WUSCI (>18 months) will complete an overground WRE-assisted walking program (34 sessions; 60 min/session), supervised by a physiotherapist, during a 16-week period (1–3 sessions/week). Data will be collected 1-month prior, at the beginning, at the end, and 2 months after completing the program. Assessments will characterize sociodemographic characteristics; anthropometric parameters; sensorimotor impairments; pain; lower extremity range of motion and spasticity; wheelchair abilities; cardiorespiratory fitness; upper extremity strength; bone architecture and mineral density at the femur, tibia and radius; total and regional body composition; health-related quality of life; and psychological health. Interviews and an online questionnaire will be conducted to measure users’ satisfaction and perspectives at the end of the program. Differences across measurement times will be verified using appropriate parametric or nonparametric analyses of variance for repeated measures.
Results:
This study is currently underway with active recruitment in Montréal, Québec, Canada. Results are expected in 2021 (spring).
Conclusions:
The results from this study will be essential to guide the development, implementation, and evaluation of future evidence-based WRE-assisted walking programs offered in the community, and to initiate a reflection regarding the use of WRE during initial rehabilitation following a spinal cord injury. Clinical Trial: U.S. National Library of Medicine (clinicaltrials.gov), NCT03989752. Registered on June 7, 2019.
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