Multimodality Intervention for Function and Metabolism in SCI
Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
Summary
The proposed phase 2 trial a randomized, placebo-controlled, parallel group trial in persons
with cervical or thoracic SCI, AIS grade A, B, C, or D, 6 months or later after injury. The
trial will test the hypothesis that a Home-Based Multimodality Functional Recovery and
Metabolic Health Enhancement Program that addresses multiple pathophysiologic factors in SCI
and includes functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry
and an androgen will be more efficacious than functional electrical stimulation during leg
cycling (FES-LC) plus arm ergometry plus placebo in improving aerobic capacity, function,
metabolism, bone health, and wellbeing.
Phase:
Phase 2
Details
Lead Sponsor:
Brigham and Women's Hospital
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institutes of Health (NIH) Spaulding Rehabilitation Hospital