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Stand Training for Spinal Cord Injury

Phase 1 & 2
Waitlist Available
Led By Gail F Forrest, PhD
Research Sponsored by Kessler Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 38 weeks
Awards & highlights

Study Summary

This trial will help researchers understand how well a combination of treatments can improve standing and walking for people with spinal cord injuries.

Eligible Conditions
  • Spinal Cord Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~38 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 38 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Muscle Volume (percent change in muscle volume for the bilateral thigh)
Secondary outcome measures
Change in Bone (BMD of the proximal tibia and distal femur)
Change in Muscle (increase in muscle torque)

Side effects data

From 2012 Phase 4 trial • 22 Patients • NCT01208038
19%
Skin irritation
10%
Increased facial hair
5%
Blepharitis
5%
Acne
5%
per vagina spotting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Testosterone

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: ST with placebo or testosteroneExperimental Treatment2 Interventions
Stand Training as described above with Placebo or testosterone Gel applied by a pump. After a baseline testing period, TRT will begin in the treatment groups by application of a daily dose of 40.5 mg of testosterone or placebo gel. The gel is to be applied to the upper arms and shoulders and is absorbed and eliminated over the course of a day. To ensure proper dosing serum T concentration will be assessed at screening, baseline, 2 weeks, 1 month and 3 month time points. As such, follow-up with the participant will be necessary to determine the correct replacement dose of TRT, and adjustment of dose if needed, (i.e. 40.5 mg up to 81 mg of gel). If serum T levels are not within normal range at the 2 week time point, the dose will be increased in increments of 20.25 mg up to 81 mg.
Group II: ST with Placebo or Testosterone and ESExperimental Treatment3 Interventions
Stand Training described above with Placebo or testosterone gel applied by a pump. Electrical stimulation will be applied via bifurcated leads and self-adhesive reusable surface electrodes. The electrodes will be applied over the motor points (both legs) on the following muscles: gluteus maximus (GL), rectus femoris (RF), biceps femoris (BF), gastrocnemei (GC), and anterior tibialis (TA) of both legs. Two electrodes will be used for each muscle. One "RT300 portable stimulator" (Restorative Therapies, Inc., Baltimore, MD) will be used to induce the electrical stimulation with 10 sets of electrodes for stimulation.
Group III: ST with ESExperimental Treatment2 Interventions
Stand Training as described above in Stand Training alone and Electrical Stimulation as described above in ST with Placebo or Testosterone and ES.
Group IV: Stand Training AloneActive Control1 Intervention
Standing training will be prescribed 3 days/week (1.5 hours/sessions) for 60 sessions. All individuals randomized to stand training will train with BWST with manual assistance and will undergo a stand evaluation. During the evaluation the participants will be placed on the treadmill in an upright position and suspended in a harness by an overhead cable (i.e. BWST). A trainer will be positioned to assist the participant while standing and to provide manual assistance if needed. The amount of BWS and level of assistance given for each body segment will be recorded. The BWS level at which the participant can independently support good standing posture will also be recorded. Standing time while on treadmill and overground will be recorded daily as part of the training sessions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Electrical Stimulation
2013
Completed Phase 2
~410

Find a Location

Who is running the clinical trial?

Kessler FoundationLead Sponsor
173 Previous Clinical Trials
10,652 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
227,138 Total Patients Enrolled
Gail F Forrest, PhDPrincipal InvestigatorKessler Foundation
3 Previous Clinical Trials
61 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
TRT in Combination With Electrical Stimulation and Standing: Effect on Muscle and Bone in Spinal Cord Injured Males
Gail Forrest 2017. "TRT in Combination With Electrical Stimulation and Standing: Effect on Muscle and Bone in Spinal Cord Injured Males". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02317640.
All > Testosterone > Spinal Cord
~7 spots leftby Apr 2025
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