Feasibility Study for Enhancing Gait Following Stroke With Implanted Microstimulators
|ClinicalTrials.gov Identifier: NCT01640041|
Recruitment Status : Completed
First Posted : July 13, 2012
Last Update Posted : January 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hemiparesis||Device: Radio-frequency Microstiumulator||Not Applicable|
The primary objective (Aim I) of this study is to evaluate whether the RFM Gait System can restore the capability to perform the components of gait required for safe, functional walking, for patients in the chronic phase after stroke (> 12 months). We will assess the treatment provided by the RFM system at the Cleveland VA compared to the FNS percutaneous Schreiner electrodes and custom-designed controller previously investigated by the investigators.
The similarities between the RFM-based and percutaneous FNS systems will be assessed using six gait components required for the execution of functional, safe gait, which are lower limb strength, coordination, an index of walking endurance, muscle tone, walking speed, and quality of life.
The secondary objective of this study is to test the technological performance and safety of the RFM Gait System. Measures of technology performance and safety include implantation time; anchoring capability at the motor point of the muscle; reliability of the RFMs during use; reliability of electrical performance of the system; comfort of the system (with stimulation off); comfort of the electrical stimulus.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Feasibility Study for Enhancing Gait Following Stroke With Implanted Microstimulators|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||January 2010|
Device: Radio-frequency Microstiumulator
All participants will receive leg implants and will be trained first in the clinical and subsequently perform stimulation-assisted exercises in the home - for an overall duration of 6 months post-implant. Subsequently, exercise programs will continue without stimulation. Patient condition will be assessed at 9, 12 and 24 months post-implant.
Other Name: The specific device name is the Radio Frequency Microstiumlator (RFM) System.
- Change from baseline to Month 24 of swing phase gait components and knee control during stance phase with 6 gait components. [ Time Frame: 24 months ]
The six gait components listed below:
- Ankle plantar-flexion at Heel Strike
- Ankle Dorsiflexion during Peak Swing
- Knee Flexion at Toe Off
- Knee Flexion Peak Swing
- Knee Extension at Heel Strike
- Knee Flexion at Mid Stance
- Change from baseline to Month 24, without stimulation, of four scales and two QOL questionnaires. [ Time Frame: 24 months ]
The four scales are:Six Minute Walk Test, Manual Muscle Test, Fugl-Meyer Coordination Scale, and the Ashworth Scale.
The two QOL questionnaires are: Craig Handicap Assessment & Reporting Technique (CHART) and Stroke Impact Scale (SIS):
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01640041
|United States, Ohio|
|VA Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Janis J Daly, PhD, MSPT||Cleveland VA Medical Center|
|Principal Investigator:||Robert Ruff, MD, PhD||Cleveland VA Medical Center|