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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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

Study details
    Spinal Cord Injuries

NCT05982171

Craig Hospital

13 February 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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