Effects of an Overground Walking Program With a Robotic Exoskeleton on Long-Term Manual Wheelchair Users With a Chronic Spinal Cord Injury: Protocol for a Self-Controlled Interventional Study

Background: In wheelchair users with a chronic spinal cord injury (WU_SCI), prolonged nonactive 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 may be a promising physical activity intervention to counter these detrimental health effects.

Objective: This study's overall goals are as follows: (1) to determine the effects of a 16-week wearable robotic exoskeleton-assisted walking program on organic systems, functional capacities, and multifaceted psychosocial factors and (2) to determine self-reported satisfaction and perspectives with regard to the intervention and the device.

Methods: A total of 20 WU_SCI, who have had their injuries for more than 18 months, will complete an overground wearable robotic exoskeleton-assisted walking program (34 sessions; 60 min/session) supervised by a physiotherapist over a 16-week period (one to three sessions/week). Data will be collected 1 month prior to the program, at the beginning, and at the end as well as 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 levels 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 the spring of 2021.

Conclusions: The results from this study will be essential to guide the development, implementation, and evaluation of future evidence-based wearable robotic exoskeleton-assisted walking programs offered in the community, and to initiate a reflection regarding the use of wearable robotic exoskeletons during initial rehabilitation following a spinal cord injury.

Trial registration: ClinicalTrials.gov NCT03989752; https://clinicaltrials.gov/ct2/show/NCT03989752.

International registered report identifier (irrid): DERR1-10.2196/19251.