ACTIVE_NOT_RECRUITING

Transcutaneous Spinal Cord Stimulation to Promote Walking Recovery After Spinal Cord Injury

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to investigate the effects of transcutaneous spinal cord stimulation (TSCS) combined with exoskeleton training, as compared to exoskeleton training alone to improve motor function in individuals with incomplete spinal cord injury who are 12 months or less post-injury. Participants will be randomly assigned to a treatment group (exoskeleton training with TSCS, or exoskeleton training without TSCS). Participants in both groups will undergo a baseline evaluation, then take part in 24, 1-hour training sessions at Craig Hospital. After the 24 sessions have concluded, participants will undergo a post-treatment evaluation as well as a follow-up evaluation four weeks after training is completed. Researchers will compare the two groups by evaluating the following areas: * walking ability and speed * lower extremity strength, activation, and spasticity * trunk control * bowel and bladder function

Official Title

Transcutaneous Spinal Cord Stimulation to Promote Walking Recovery After Spinal Cord Injury

Quick Facts

Study Start:2023-11-15
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05982171

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * \< 12 months post traumatic iSCI C4-T10 with signs of upper motor neuron injury
  2. * AIS C or D classification
  3. * 18 years and older
  4. * Height 5'0" to 6'4"
  5. * Weight 220lbs or less
  6. * Sufficient upper extremity strength to manage a stability aide
  7. * Medical clearance for high intensity gait training
  8. * Walking \<1.46 m/s
  9. * Intact skin in on pelvis, lower extremities and back
  10. * Passive range of motion at shoulders, trunk, hips, knees \& ankles within functional limits
  1. * Unstable or symptomatic cardiac or respiratory issues
  2. * Recent history of fracture, contractures, pressure injury, deep vein thrombosis, or other infection that might interfere with participation in study
  3. * Received Botox injections to the lower extremities within the last six months
  4. * Pregnancy
  5. * Cauda Equina injury
  6. * Any other issue that in the opinion of the investigator would impact study participation
  7. * Non-English Speaking

Contacts and Locations

Study Locations (Sites)

Craig Hospital
Englewood, Colorado, 80113-2811
United States

Collaborators and Investigators

Sponsor: Craig Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-15
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2023-11-15
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Spinal Cord Injuries