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Testosterone Replacement Therapy in Combination With Electrical Stimulation and Standing: Effect on Muscle and Bone in Spinal Cord Injured Males.
The aim of this study is to understand what happens to muscle and bone in spinal cord injured males after four months of training using stand training, with body weight support (BWS), with testosterone replacement therapy (TRT), and electrical stimulation (ES). Specifically, researchers will investigate nerve, muscle, and bone changes in the lower limbs in response to stand training and ES when combined with TRT compared to i) standing alone with TRT; ii) stand training alone with placebo; iii) stand training alone and ES with placebo.
Details
| Lead sponsor | Kessler Foundation |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | UNKNOWN |
| Enrolment | 56 |
| Start date | 2017-03-15 |
| Completion | 2022-10 |
Conditions
- Spinal Cord Injury
Interventions
- Testosterone Gel applied by a pump
- Stand Training
- Electrical Stimulation
Primary outcomes
- Muscle Volume (percent change in muscle volume for the bilateral thigh) — 38 weeks
Muscle volume will be measured in the thigh. The percent change in muscle volume for the bilateral thigh will be compared to before the intervention to after the intervention.
Countries
United States