Spinal Cord Injuries Clinical Trial
Official title:
Transcutaneous Spinal Cord Stimulation to Promote Walking Recovery After Spinal Cord Injury
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
Status | Recruiting |
Enrollment | 30 |
Est. completion date | September 15, 2024 |
Est. primary completion date | September 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - < 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 Exclusion Criteria: - Unstable or symptomatic cardiac or respiratory issues - Recent history of fracture, contractures, pressure injury, deep vein thrombosis, or other infection that might interfere with participation in study - Received Botox injections to the lower extremities within the last six months - Pregnancy - Cauda Equina injury - Any other issue that in the opinion of the investigator would impact study participation - Non-English Speaking |
Country | Name | City | State |
---|---|---|---|
United States | Craig Hospital | Englewood | Colorado |
Lead Sponsor | Collaborator |
---|---|
Craig Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in score on Walking Index for SCI (WISCI) II | Assesses the amount of physical assistance/devices needed for walking following paralysis from SCI (scale of 0-20 with higher score indicating less need for assistance) | Baseline to Immediately After Intervention | |
Secondary | Change in walking speed as measured by the 10 Meter Walk Test | Participants walk a ten-meter track; time to walk the middle six meters is recorded and converted to meters/second (speed) | Baseline to Immediately After Intervention | |
Secondary | Change in distance walked as measured by the 6 Meter Walk Test | Measures distance walked (in meters) over 6 minute time period | Baseline to Immediately After Intervention | |
Secondary | Change in lower extremity strength as measured by Lower Extremity Motor Score (LEMS) | Assesses strength in 10 lower extremity muscle groups (each muscle scored 0-5 with higher score for greater strength; total score ranges 0-50. | Baseline to Post-treatment | |
Secondary | Change in spasm frequency and severity as measured by Penn Spasm Frequency | Self-report measure of perception of spasticity frequency (0 to 5 scale with higher score more frequent spasms) and severity (1-3 scale with higher score more severe spasms) | Baseline to Immediately After Intervention | |
Secondary | Change in bowel function as measured by Neurogenic Bowel Dysfunction Scale | Symptom based questionnaire evaluating bowel dysfuntion and its impact on quality of life (score 0-47 with higher score indicating greater bowel dysfunction) | Baseline to Immediately After Intervention | |
Secondary | Change in bladder function as measured by Neurogenic Bladder Symptom Scale | Symptom based questionnaire evaluating bladder function and its impact on quality of lifehe Neurogenic Bladder Symptom Score (NBSS) is a validated 24 item questionnaire that measures bladder symptoms across 3 different domains: incontinence (scored 0-29), storage and voiding (scored 0-22), and consequences (scored 0-23); there is a single general urinary QOL question scored from 0 (pleased) to 4 (unhappy | Baseline to Immediately After Intervention | |
Secondary | Change in balance/trunk control as measure by the Function in Sitting Test Spinal Cord Injury | Assesses static, proactive, and reactive balance as well as sensory integration. Each area assessed on scale of 0-4 with higher score indicating more independent trunk control. | Baseline to Immediately After Intervention |
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