TRT in Combination With Electrical Stimulation and Standing: Effect on Muscle and Bone in Spinal Cord Injured Males

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

March 15, 2017

Primary Completion Date

October 31, 2022

Study Completion Date

October 31, 2022

Conditions
Spinal Cord Injury
Interventions
DRUG

Testosterone Gel applied by a pump

After being diagnosed with low testosterone levels the participant will be given a 30-day supply of the Testosterone/placebo gel (40.5 mg/day). The gel is to be applied every morning on clean and dry area of skin of the upper arms and shoulders.

OTHER

Stand Training

Stand training with BWST with manual assistance. Participant is placed on treadmill in an upright position and suspended in a harness by an overhead cable. A trainer will aid the participant in pelvis and trunk stabilization, by applying anterior forces at the pelvis and/or posterior forces at the shoulders and ensure that the trunk and pelvis are not flexed or hyper-extended.

DEVICE

Electrical Stimulation

Electrical Stimulation (ES) will be applied via bifurcated leads and self-adhesive reusable surface electrodes. The electrodes will be applied over the motor points of both legs. Two electrodes will be used for contracting each muscle.

Trial Locations (1)

07052

RECRUITING

Kessler Foundation, West Orange

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

Kessler Foundation

OTHER