Locomotor Training for Wounds

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Wounds+20 More
Locomotor Training - Behavioral
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial will study the feasibility of using testosterone replacement therapy along with locomotor training to improve walking function in men with spinal cord injuries and low testosterone levels.

Eligible Conditions
  • Wounds
  • Testosterone Deficiency
  • Spinal Cord Injuries
  • Spinal Cord Diseases
  • Duck Gait
  • Gonadal Disorders
  • Androgen Deficiency
  • Hypogonadism
  • Walking, Difficulty
  • Axonotmesis
  • Spinal Cord
  • Trauma, Spinal Cord
  • Genital Diseases, Male
  • Nervous System Diseases
  • Endocrine System Diseases
  • Gait Disorders, Neurologic
  • Hormone Deficiency
  • Central Nervous System Diseases

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: baseline, 1 month, 3 months, 6 months

Month 6
change in 10m walk test (10mWT)
change in 6 min walk test (6MWT)
Month 6
change in bone formation marker
change in bone resorption marker
change in distal femur bone mineral density
change in knee extensor peak torque
change in thigh muscle cross-sectional area

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

non-interventional control
1 of 3
testosterone enanthate
1 of 3
locomotor training, testosterone enanthate
1 of 3
Active Control
Experimental Treatment

21 Total Participants · 3 Treatment Groups

Primary Treatment: Locomotor Training · No Placebo Group · Phase 2

testosterone enanthate
Drug
Experimental Group · 1 Intervention: Testosterone Enanthate · Intervention Types: Drug
locomotor training, testosterone enanthateExperimental Group · 2 Interventions: Locomotor Training, Testosterone Enanthate · Intervention Types: Behavioral, Drug
non-interventional controlNoIntervention Group · 1 Intervention: non-interventional control · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Locomotor Training
2013
Completed Phase 1
~110
Testosterone enanthate
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1 month, 3 months, 6 months

Who is running the clinical trial?

Brooks RehabilitationOTHER
11 Previous Clinical Trials
1,956 Total Patients Enrolled
University of FloridaOTHER
1,235 Previous Clinical Trials
696,964 Total Patients Enrolled
North Florida/South Georgia Veterans Health SystemOTHER
7 Previous Clinical Trials
1,964 Total Patients Enrolled
North Florida Foundation for Research and EducationLead Sponsor
13 Previous Clinical Trials
752 Total Patients Enrolled
Joshua F Yarrow, PhDPrincipal InvestigatorNorth Florida/South Georgia Veterans Health System

Eligibility Criteria

Age 18+ · Male Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a diagnosis of an incomplete SCI involving spinal segments L1 or above or a clinically complete SCI involving spinal segments T2-L1, with upper motor neuron injury signs (i.e.
You are willing to take TRT as instructed by the study staff and to abide by study protocol.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: October 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.