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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \< 12 months post traumatic iSCI C4-T10 with signs of upper motor neuron injury

• AIS C or D classification

• 18 years and older

• Height 5'0 to 6'4

• Weight 220lbs or less

• Sufficient upper extremity strength to manage a stability aide

• Medical clearance for high intensity gait training

• Walking \<1.46 m/s

• Intact skin in on pelvis, lower extremities and back

• Passive range of motion at shoulders, trunk, hips, knees \& ankles within functional limits

Locations
United States
Colorado
Craig Hospital
RECRUITING
Englewood
Contact Information
Primary
Clare Morey, MA
cmorey@craighospital.org
303-789-8621
Backup
Katie Hays, DPT
khays@craighospital.org
303-789-8276
Time Frame
Start Date: 2023-11-15
Estimated Completion Date: 2025-12-15
Participants
Target number of participants: 30
Treatments
Experimental: Exoskeleton+Transcutaneous Spinal Cord Stimulation
Treatment in this group will involve walking overground using the assistance of an exoskeleton while receiving a therapeutic level of transcutaneous spinal cord stimulation (TSCS) thoracolumbar spinal cord areas. Focus will be on stepping at a high intensity throughout the session as measured by heart rate.
Sham_comparator: Exoskeleton+Sham Stimluation
Treatment in this group will involve walking overground using the assistance of an exoskeleton while receiving a non-therapeutic level of stimulation (considered to be a sham). Focus will be on stepping at a high intensity throughout the session as measured by heart rate.
Related Therapeutic Areas
Sponsors
Leads: Craig Hospital

This content was sourced from clinicaltrials.gov