drugset / Trial / NCT04460872
Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury
Phase 2
Recruiting
21 enrolled
North Florida Foundation for Research and Education
Brooks Rehabilitation · collabNorth Florida/South Georgia Veterans Health System · collabUniversity of Florida · collabVA Eastern Colorado Health Care System · collab
Non-randomizedParallel-groupOpen-labelSupportive care
Summary
This pilot study will determine the feasibility of implementing a combinatory rehabilitation strategy involving testosterone replacement therapy (TRT) with locomotor training (LT; walking on a treadmill with assistance and overground walking) in men with testosterone deficiency and walking dysfunction after incomplete or complete spinal cord injury. The investigators hypothesize that LT+TRT treatment will improve muscle size and bone mineral density in men with low T and ambulatory dysfunction after incomplete or complete SCI, along with muscle fundtion and walking recovery in men with T low and ambulatory dysfunction ater incomplete SCI.
Timeline
- Start
- 2021-01-31
- Primary completion
- 2026-01-30
- Completion
- 2026-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Testosterone Enanthate | Small molecule | 100 mg | Intramuscular |