Spinal Cord Injuries
Conditions
Brief 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
Interventions
DEVICEExo + TSCS
Participants will receive TSCS delivered with the ONWARD Lift system at 1ms using a 10kHz carrier frequency delivered at 30Hz, with an amplitude set for each participant based on their ability to increase voluntary movement output.
DEVICEExo + Sham
The ONWARD Lift system will also be used to deliver sham stimulation which will also be delivered at 1ms using a 10kHz carrier frequency delivered at 30Hz, and an amplitude of 1ma which has been used in other sham stimulation protocols and is not sufficient to induce activation of lumbosacral neuronal pools.
Sponsors
Craig Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in score on Walking Index for SCI (WISCI) II | Baseline to Immediately After Intervention | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in walking speed as measured by the 10 Meter Walk Test | Baseline to Immediately After Intervention | Participants walk a ten-meter track; time to walk the middle six meters is recorded and converted to meters/second (speed) |
| Change in distance walked as measured by the 6 Meter Walk Test | Baseline to Immediately After Intervention | Measures distance walked (in meters) over 6 minute time period |
| Change in lower extremity strength as measured by Lower Extremity Motor Score (LEMS) | Baseline to Post-treatment | Assesses strength in 10 lower extremity muscle groups (each muscle scored 0-5 with higher score for greater strength; total score ranges 0-50. |
| Change in spasm frequency and severity as measured by Penn Spasm Frequency | Baseline to Immediately After Intervention | 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) |
| Change in bowel function as measured by Neurogenic Bowel Dysfunction Scale | Baseline to Immediately After Intervention | Symptom based questionnaire evaluating bowel dysfuntion and its impact on quality of life (score 0-47 with higher score indicating greater bowel dysfunction) |
| Change in bladder function as measured by Neurogenic Bladder Symptom Scale | Baseline to Immediately After Intervention | 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 |
| Change in balance/trunk control as measure by the Function in Sitting Test Spinal Cord Injury | Baseline to Immediately After Intervention | 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. |
Countries
United States
Outcome results
None listed