Prevention of Post-Stroke Hand/Wrist Flexion Deformity
Condition: Hand Deformities
MeSH terms: Hand Deformities; Congenital Abnormalities
Study type: Interventional
Phase: Phase 1

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 description: 
      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.
    

Intervention name(s): BION stimulation
Intervention type(s): Device
Intervention description(s): BION™ Experimental Group
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.
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. 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuromuscular stimulator; Flexor deformities of wrist and fingers