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Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury

NCT04460872 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-05-06

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injury
  • Spinal Cord Injuries
  • Trauma, Nervous System
  • Wounds and Injury
  • Central Nervous System Diseases
  • Spinal Cord Diseases
  • Gonadal Disorders
  • Endocrine System Diseases
  • Hypogonadism
  • Genital Diseases, Male
  • Spinal Cord Trauma
  • Injuries, Spinal Cord
  • Walking, Difficulty
  • Gait Disorders, Neurologic
  • Locomotion Disorder, Neurologic
  • Wounds and Injuries
  • Nervous System Diseases
  • Testosterone Deficiency
  • Androgen Deficiency
  • Hormone Deficiency

Interventions

DRUG

Testosterone Enanthate

Subjects receive testosterone (100 mg/week) by intramuscular injection

BEHAVIORAL

Locomotor Training

Subjects receive locomotor training (4 sessions/week for 2-3 months)

Sponsors & Collaborators

  • North Florida/South Georgia Veterans Health System

    collaborator OTHER

  • Brooks Rehabilitation

    collaborator OTHER

  • University of Florida

    collaborator OTHER

  • VA Eastern Colorado Health Care System

    collaborator FED

  • North Florida Foundation for Research and Education

    lead OTHER

Principal Investigators

  • Joshua F Yarrow, PhD · North Florida/South Georgia Veterans Health System

  • Dana M Otzel, Phd · North Florida/South Georgia Veterans Health System

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2026-01-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04460872 on ClinicalTrials.gov