Efficacy of Functional Electrical Stimulation (FES) in Persons Receiving Botulinum Neurotoxin for Upper Extremity Spasticity "Botox + FES"

Completed

Phase N/A Results

Trial Description

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.

Conditions

Interventions

  • Botulinum toxin (Dysport)Drug
    Intervention Desc: Antispasticity agent.
  • Electrical stimulation Other
    Intervention Desc: This category includes any form of electrical stimulation intended to improve motor function or pain after stroke.
  • Functional Electrical Stimulation (FES) through the Ness H200 Device
    Other Names: NESS H200™ Product Specification
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: 2
    Description: In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Participants will be randomized into one of two groups. (1) No Intervention: Individuals randomized into this group will only receive specialized therapy associated with this population. (2) Experimental: In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device. In addition, participants will have ARAT, CMA, and MAS done at initial assessment and at the 6-week, 9-week, and 12-week visits. MAL-Self Report will be done at initial assessment and at each visit.

Outcomes

Type Measure Time Frame Safety Issue
Primary Upper extremity use during activities of daily living assessed observationally by the Motor Activities Log (MAL-O)
Secondary Dexterous hand function as measured by the Action Research Arm Test (ARAT); client's perception of self-performance in activities of daily living assessed with the (MAL - Self Report); global arm function assessed by the Chedoke-McMaster Assessment (CMA); clinical spasticity assessed by the Modified Ashworth Scale (MAS).
Secondary Dexterous hand function as measured by the Action Research Arm Test (ARAT) initial assessment and at the 6-week, 9-week, and 12-week visits No
Secondary Client's perception of self-performance in activities of daily living assessed with the (MAL - Self Report) throughout the duration of the study No
Secondary Global arm function assessed by the Chedoke-McMaster Assessment (CMA) initial assessment and at the 6-week, 9-week, and 12-week visits No
Secondary Clinical spasticity assessed by the Modified Ashworth Scale (MAS) initial assessment and at the 6-week, 9-week, and 12-week visits No
Primary Change From Baseline in Arm Function Based on Motor Activities Log (MAL-O) 12 weeks No
Secondary Change From Baseline in Dexterous Hand Function as Measured by the Action Research Arm Test (ARAT) 12 weeks No
Secondary Change From Baseline in Self-performance in Activities of Daily Living Assessed With the (MAL - Self Report) 12 weeks No

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