A device to improve sitting posture and balance for individuals with spinal cord injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a surgically implanted functional electrical stimulation (FES) system designed to enhance trunk and hip stability in individuals with spinal cord injuries. The procedure involves inserting electrodes into the trunk and hip muscles, which are connected to a stimulator located in the abdomen. After a recovery period, participants will undergo training to use the neuroprosthesis, and their strength, balance, and functional abilities will be assessed both with and without the device. The goal is to determine how FES can improve daily activities such as sitting, breathing, and mobility.

Why it matters

Who can join: the full rules

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

Where it's running

• Louis Stokes VA Medical Center, Cleveland, OH
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Ronald Triolo, PhD — Louis Stokes VA Medical Center, Cleveland, OH
• Study coordinator: Lisa M Lombardo, MPT
• Email: Lisa.Lombardo2@va.gov
• Phone: (216) 791-3800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.