Hand Deformities Clinical Trial
Official title:
BION Implantable Microstimulator
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.
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 motion exercises)
The research participant is instructed in self-administered, standard range of motion
stretching exercises. If the patient is unable to stretch the fingers into extension, a
family member or a care-giver will be instructed to assist. They will be instructed to
exercise the affected hand twice daily, repeating the exercise a minimum of 15 times in each
session for 6 weeks. Control subjects will return to the clinic every two weeks for the
first 6 weeks and every 3 weeks during the follow-up period. During these visits, passive
range of motion testing will be administered.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment