Exoskeletal-assisted walking combined with transcutaneous spinal cord stimulation to improve bone health in persons with spinal cord injury: study protocol for a prospective randomised controlled trial.
Study Goal
The researchers aimed to compare the effects of exoskeletal-assisted walking (EAW) alone versus EAW combined with transcutaneous spinal cord stimulation (EAW+tSCS) on bone density, geometry, and strength in individuals with chronic spinal cord injury.
Results Summary
The study protocol outlines a randomized trial to evaluate the impact of EAW and EAW+tSCS on bone health, but results are not yet available as the abstract describes the planned methodology rather than outcomes.
Population
Individuals with chronic non-ambulatory spinal cord injury (n=16).
Effective Dosage
108 overground training sessions (60 minutes each, 3 times per week for 36 weeks).
Duration
9 months.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
exoskeletal-assisted walking (EAW) alone | neutral | bone density, geometry and strength | chronic SCI participants | - | compare the effect | #1 |
exoskeletal-assisted walking (EAW) plus transcutaneous spinal cord stimulation (EAW+tSCS) | neutral | bone density, geometry and strength | chronic SCI participants | - | compare the effect | #2 |
INTRODUCTION: Persons with non-ambulatory spinal cord injury (SCI) undergo immediate unloading of the skeleton and, as a result, have marked loss of bone mineral density below the level of lesion that is directly associated with increased risk of long-bone fractures. There is a paucity of research that has successfully implemented rehabilitation and/or exercise training interventions to mitigate bone loss after acute SCI or reverse bone loss that has already occurred in chronic SCI. This paper describes a research protocol to compare the effect of exoskeletal-assisted walking (EAW) alone versus EAW plus transcutaneous spinal cord stimulation (EAW+tSCS) on bone density, geometry and strength in a cohort of chronic SCI participants. METHODS AND ANALYSIS: After meeting eligibility criteria and completing baseline testing, sixteen participants will be block randomised into the EAW alone group or the EAW+tSCS combined group (n=8 each group). Each group will receive a total of 108 overground training sessions (60 min sessions, 3 times a week, for 36 weeks) for the 9-month training period. Imaging for bone density and geometry by dual-energy X-ray absorptiometry and peripheral quantitative CT will be performed prior to starting the intervention (baseline), after 72 training sessions, and again after 108 sessions in each of the intervention arms. CT imaging of both lower extremities will be performed at baseline and at the 9-month time point in each of the intervention arms. Finite element models of bone loading will be generated based on three-dimensional (3D) reconstruction of bone architecture from CT imaging prior to and 9 months after the intervention. ETHICS AND DISSEMINATION: This study is currently approved by the Kessler Foundation and James J. Peters VA Medical Center Institutional Review Board. A member of the research team will review and explain the study consent form and will have all eligible participants sign prior to participation in the study. Results from this study will be disseminated to clinicians and researchers in the SCI community at national and international conferences. TRIAL REGISTRATION NUMBER: NCT03096197.