RecruitingNot Applicable

A Neuroprosthesis for Seated Posture and Balance

United States10 participantsStarted 2011-11-30

Plain-language summary

The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * C4-T12 * ASIA Scale A through C * Time post injury greater than 6 months * Innervated and excitable trunk and pelvis musculature * Absence of acute or chronic psychological problems or chemical dependency * Range of motion within normal limits * Controlled spasticity and absence of hip flexion and adduction spasm * Height and weight within normal limits * No history of balance problems or spontaneous falls * No history of spontaneous fracture or evidence low bone density * No acute orthopaedic problems * No acute medical complications * Adequate social support and stability * Able to speak and read English Exclusion Criteria: * Pregnancy * Non-English speaking

What they're measuring

Effect of Trunk stimulation on control seated posture, respiration, seated interface pressures, reach ability, seated stability & personal mobility.

Timeframe: up to 36 months

Trial details

NCT IDNCT01474148

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2027-01-31

Contact for this trial

Lisa M Lombardo, MPT

(216) 791-3800 Lisa.Lombardo2@va.gov

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