Evaluation of an Advanced Lower Extremity Neuroprostheses

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries; Paralysis; Tetraplegia; Stroke; Paraplegia

• Registration Number: NCT00623389
• Lead Sponsor: Case Western Reserve University

Brief Summary

The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate exercise, standing, stepping and/or balance in people with various degrees of paralysis.

Detailed Description

Protocol Outline: Patents undergo surgery in which electrodes are implanted into muscles of the trunk and legs. Electrode leads are connected to an stimulator/telemeter. Following implantation, patients undergo training in standing, transfers and other advanced mobility skills using the functional electrical stimulation system. A prescribed course of exercise, functional training and rehabilitation with the implanted stimulation system, followed by laboratory assessments of strength, balance and functional abilities with and without the system, as well as the technical performance of the implanted components. Home-based training follows prior to discharge for home use of the system.

Patients are followed at 6 and 12 months after discharge and then annually thereafter.

Study Timeline

• Study First Submitted: 2008-01-24
• Study First Submitted QC: 2008-02-15
• Study First Posted: 2008-02-26
• Study Start: 2018-06-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-12
• Last Update Posted: 2025-06-15
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Device reliability and technical performance measuring changes in walking distance from baseline at discharge to 12 months after discharge	Change from immediately after intervention and 1 year after intervention	Repeated measures of walking distance in meters
Device reliability and technical performance measuring changes in standing loads from baseline at discharge to 12 months after discharge	Change from immediately after intervention and 1 year after intervention	Repeated measures of arm/leg loading measured in Kg
Device reliability and technical performance measuring changes in standing duration from baseline at discharge to 12 months after discharge	Change from immediately after intervention and 1 year after intervention	Repeated measures of standing duration in minutes
Device reliability and technical performance measuring changes in walking duration from baseline at discharge to 12 months after discharge	Change from immediately after intervention and 1 year after intervention	Repeated measures of walking time in minutes

Secondary Outcome Measures

Name	Time	Method
Device operability measuring changes in functional activities of daily living from baseline at discharge and 12 months after discharge	Change from immediately after intervention and 1 year after intervention	Repeated measures of standing reach in cm, and transfer height in cm

Trial Locations

Locations (2)

Louis Stokes Cleveland VA Medical Center; 🇺🇸 Cleveland, Ohio, United States

MetroHealth System; 🇺🇸 Cleveland, Ohio, United States