Efficacy of Functional Electrical Stimulation (FES) in Persons Receiving Botulinum Neurotoxin for Upper Extremity Spasticity
Condition: Upper Extremity Spasticity; Stroke; Acquired Brain Injury
MeSH terms: Muscle Spasticity; Brain Injuries
Study type: Interventional

Summary: 
      FES is a form of treatment with a device to aid movement in people who have had damage to
      their brain or spinal cord. Small electrical impulses are used to excite/stimulate the nerves
      that supply paralyzed muscles. This activates those muscles, enabling them to produce basic
      but useful movement. Self-adhesive patches (electrodes) are placed on the skin close to the
      nerve that supplies the muscle and are connected by wires to a stimulator that produces the
      impulses. In this way, FES is used to correct the muscle weakness that is caused by injury to
      the brain or spinal cord.

      Repetitive task practice is an "activity-based" therapy program that has been shown to
      enhance the recovery of hand and arm functions after stroke. This therapy consists of a set
      of training activities that are designed by a qualified therapist specific to your functional
      abilities that are to be performed with the impaired hand. These activities are designed to
      stimulate functional improvement with repetitive practice.

      Spasticity is a nervous system disorder where certain muscles are continuously contracted.
      Botox injections are commonly used to help to reduce spasticity in areas of the body with
      increased muscle tone. This research is designed to look at any additional benefit that may
      occur when Botox injections are combined with specific occupational therapy exercises and
      with a device that uses functional electrical stimulation (FES) to help improve muscle
      function after stroke.
    

Detailed description: 
      This is a single-blinded, randomized controlled trial examining the effect of repetitive task
      practice (RTP) and functional electrical stimulation (FES) in individuals who receive routine
      clinical Botox ® injections for upper extremity spasticity. Botox® injections in combination
      with repetitive task practice (RTP) is used routinely to manage upper limb spasticity after
      stroke or acquired brain injury. RTP is an activity-based rehabilitation program that has
      been shown effective in promoting motor recovery (Wolf et al., 2002), but it requires a
      sufficient level of baseline motor function. Since FES enhances motor function, we
      hypothesize that an FES-assisted RTP intervention will provide greater improvement in hand
      function than RTP alone in patients receiving Botox ® injections.

      The primary outcome will be upper extremity use during activities of daily living assessed
      observationally by the motor activities log (MAL-O). Secondary outcomes will be 1) dexterous
      hand function as measured by the action research arm test (ARAT); 2) client's perception of
      self-performance in activities of daily living assessed with the (MAL - Self Report); 3)
      global upper extremity impairment assessed by the Chedoke-McMaster Assessment (CMA); and 4)
      clinical spasticity assessed by the Modified Ashworth Scale (MAS).

      The primary endpoint will be 6 weeks post-injection. Outcomes will also be assessed at a
      secondary endpoint, 12 weeks post-injection, to determine the persistence of treatment
      effects.
    

Intervention name(s): Functional Electrical Stimulation (FES) through the Ness H200
Intervention type(s): Device
Intervention description(s): Specialized exercises will be presented to the participants in this group. They will be instructed on how to attach and complete this exercise program utilizing the FES device.
Other intervention name(s): NESS H200™ Product Specification
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Botulinum Toxin; Ness H200; Functional Electrical Stimulation; Repetitive Task Practice