Clinical Trial: Prevention of Post-Stroke Hand/Wrist Flexion Deformity

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: BION Implantable Microstimulator

Brief Summary: The study looks at a new treatment for wrist and finger contractures -- a condition where the affected hand is in a "closed" position, with the wrist and fingers stiff and difficult to move from that position. We want to study if stimulation of wrist and finger muscles using an implanted neuromuscular stimulator (BION) will be more or less effective than doing passive exercises of the affected hand to improve the range of movement at wrist and finger joints. Subjects of this study will be randomized into one of three groups: one doing passive movement therapy; one receiving surface stimulation (electrical stimulation with electrodes on the skin of the arm) and one doing BION® therapy. The passive movement group will do therapy for 12 weeks. Subjects in either stimulation group will receive stimulation for 6 weeks and then only passive therapy for 6 weeks.

Detailed Summary:

BION™ Experimental Group

Following implantation, the patients receiving BIONs will have a 3 to 7 day healing period. During this period, subjects will not receive active therapy. At the end of this healing period, subjects will come to the testing center so that the examiner can program the exercise patterns. They will be instructed to increase the strength of their muscle contractions as tolerance permits. The goal for the BION™ patients is to achieve 30 minutes of stimulation twice daily, using a cycled stimulation at frequencies adequate to produce tetanic contraction, (typically 25-35 pps) that raises the joint through full range of motion against gravity (a range graded as 3/5) based on the available range of motion. The intensity, duration and frequency of the exercise program will be modified according to the progress of the participant, so that the strength of the contraction is increased over time.

Surface Stimulation Group

Patients will be instructed to stimulate twice daily for 30 minutes through surface electrodes placed according to instructions that the subject has been given. Stimulus parameters will be similar to those reported in earlier successful stimulation studies. The parameters should achieve a tetanic contraction that raises the joint through full range of motion against gravity (graded 3/5) based on the patient's available range of motion, and cycled, typically at 25-35 pps, using stimulus ramps as necessary so that contractions are smoothly graded and comfortable. Every effort will be made to ensure that the parameters needed in this group are chosen to produce a similar type of contraction to that obtained with BION™ stimulation.

Control Group with conservative therapy (Range of m
Sponsor: University of Southern California

Current Primary Outcome: passive Range of Motion, active Range of Motion, Rancho Arm Function Scale, Fugl Meyer Function Scale [ Time Frame: baseline, 2 weeks, 4 weeks and 6 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Southern California

Dates:
Date Received: February 25, 2008
Date Started: April 2004
Date Completion:
Last Updated: June 1, 2015
Last Verified: June 2015