RecruitingNot ApplicableNCT03096197

Exoskeleton and Spinal Cord Stimulation for SCI


Sponsor

Kessler Foundation

Enrollment

24 participants

Start Date

Mar 30, 2017

Study Type

INTERVENTIONAL

Conditions

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 examines whether combining exoskeleton-assisted walking (a robotic device that helps move the legs in a walking pattern) with transcutaneous lumbosacral stimulation (painless electrical signals applied to the lower back to activate spinal circuits) improves walking recovery more than exoskeleton-assisted walking alone in people with an incomplete spinal cord injury (iSCI). Participants will attend 80 training sessions (3 times per week for 28 weeks) of 60–75 minutes each. Adults aged 18–65 with an incomplete spinal cord injury at the C5–T10 level, more than 6 years post-injury, who are wheelchair-dependent and have adequate bone density and leg muscle function may be eligible. Participation involves the intensive walking rehabilitation program at the study site, including use of the exoskeleton device and (for the stimulation group) surface electrodes on the lower back. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

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.


Locations(1)

Kessler Foundation

West Orange, New Jersey, United States

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NCT03096197


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