Clinical Trial

Improving Function and Metabolism in Spinal Cord Injury

Study Description

Multimodality Intervention for Function and Metabolism in SCI

This study is a phase 2, randomized, placebo-controlled, parallel group trial in persons with C7-T12 motor level SCI, AIS grade A, B or C, 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 hybrid exercise (Functional electrical stimulation - leg cycling, FES-LC plus arm ergometry), and an androgen will be more efficacious than hybrid exercise plus placebo in improving aerobic capacity, function, metabolism, and wellbeing.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

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

Additional Information

Official Study Title

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

Clinical Trial ID

NCT03576001

ParticipAid ID

dBBoYd