Electrical Stimulation for Recovery of Hand Function in Chronic Stroke Survivors
Condition: Stroke; Hemiparesis; Hemiplegia
MeSH terms: Stroke; Hemiplegia; Paresis
Study type: Interventional

Summary: 
      Impaired hand function is one of the most frequently persisting consequences of stroke. The
      purpose of this study is to compare two different treatments -- Contralataterally Controlled
      Functional Electrical Stimulation (CCFES) and Cyclic Neuromuscular Electrical Stimulation
      (cNMES) -- for improved recovery of hand function after stroke.
    

Detailed description: 
      Hemiparesis of the upper limb is one of the most serious and most common impairments
      resulting from stroke. Approximately 75% of the over 750,000 strokes that occur annually in
      the United States cause some degree of upper extremity paralysis. Approximately 65% of stroke
      survivors still cannot use their affected hand to assist with activities of daily living 6
      months after their stroke. The impact of upper extremity impairments on disability and health
      is great, yet there are relatively few rehabilitation interventions designed to restore
      function to the impaired upper limb. Therefore, our long-term objective is to develop upper
      extremity rehabilitation therapies that are effective at restoring arm and hand function,
      that are applicable across a wide range of impairment severity, and that are readily
      implemented in the present healthcare environment.

      The purpose of this study is to estimate the efficacy of Contralataterally Controlled
      Functional Electrical Stimulation (CCFES) in reducing upper extremity impairment and activity
      limitation in chronic upper extremity hemiplegia. CCFES is a rehabilitation intervention in
      which neuromuscular electrical stimulation (NMES) is applied to the finger and thumb extensor
      muscles of the paretic upper limb to open the hand. The stroke survivor controls the
      stimulation intensity, and consequent degree of hand opening, by modulating the degree of
      opening of the contralateral unimpaired hand, which is detected by an instrumented glove.
      Thus, volitional opening of the unaffected hand produces stimulated opening of the affected
      hand. The stimulation paradigm is used to assist the stroke survivor in practicing functional
      tasks with their affected hand. We will conduct a randomized controlled trial in which
      chronic stroke survivors (>6 months post-stroke) will be randomly assigned to receive 12
      weeks of CCFES or cyclic NMES, an intervention that provides electrical stimulation of the
      hand extensors, but with preprogrammed timing and intensity. Randomization will be stratified
      on two levels of baseline hand impairment defined by the degree of voluntary finger extension
      present. Assessments of upper extremity impairment and activity limitation will be made every
      3 weeks during the treatment period and every 2 months during a 6-month follow-up period.

      This study is the first randomized controlled trial of CCFES in chronic upper extremity
      hemiplegia. Ultimately, the information learned in this study will serve to accelerate the
      development of treatments for reducing post-stroke disability.
    

Intervention name(s): Electrical stimulator
Intervention type(s): Device
Intervention description(s): • 12-week intervention
Therapist-guided task practice performed twice a week in the research laboratory. (Device used for CCFES group but not for cNMES group during these sessions.)
Self-administered CCFES or cNMES-mediated hand opening exercise performed 10 sessions per week at home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: hand; stroke; hemiplegia; electrical stimulation; recovery