RecruitingNot ApplicableNCT03096197

Exoskeleton and Spinal Cord Stimulation for SCI

Sponsor

Kessler Foundation

Enrollment

24 participants

Start Date

Mar 30, 2017

Study Type

INTERVENTIONAL

Conditions

Muscle Spasticity Spinal Cord Injury Ambulation Difficulty

Summary

The overall aim of this project is to assess the effect of combining transcutaneous lumbosacral stimulation (TLS) during Exoskeleton Assisted Walking (EAW) compared to EAW alone without stimulation on walking recovery.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether combining a wearable robotic exoskeleton with spinal cord electrical stimulation can help people with chronic spinal cord injury (SCI) regain some walking ability. Both technologies have shown individual promise, and this study tests whether they work better together. You may be eligible if... - You are between 18 and 65 years old - You have had a spinal cord injury for more than 6 years and cannot walk - Your injury is at a neurological level between C5 and T10 - You have some lower extremity muscle function (motor score of 16 or higher) - You use a wheelchair 100% of the time - You have adequate bone density in your knees (above 0.5755 g/cm²) You may NOT be eligible if... - You have a history of broken or fractured bones - You have a history of bone trauma or bone disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEExoskeleton-Assisted Walking

Exoskeleton-Assisted Walking (EAW) is an activity based therapy. Each group will receive 60 minutes of robotic intervention training per session, for a total of 80 sessions.

DEVICETranscutaneous Lumbosacral Stimulation (TLS)

EAW+TLS. This group will receive 60 minutes of exoskeleton assisted overground walking with simultaneous Transcutaneous Lumbosacral Stimulation (TLS) followed by 15 minutes of overground training without exoskeleton.