Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT03576001
PHASE2

Multimodality Intervention for Function and Metabolism in SCI

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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.

Official title: Effect of a Multimodality Intervention to Improve Function and Metabolism in Spinal Cord Injury

Key Details

Gender

All

Age Range

19 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2019-08-23

Completion Date

2025-03-30

Last Updated

2026-05-07

Healthy Volunteers

Yes

Interventions

DRUG

Testosterone Undecanoate

administered through injections by study staff

BEHAVIORAL

hybrid exercise

hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States