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

June 19, 2014 updated by: Michael C. Munin, M.D., University of Pittsburgh

Single Blind, Randomized Study to Determine the Safety and the Efficacy of Using Functional Electrical Stimulation (FES) and Repetitive Task Practice vs. Repetitive Task Practice Alone in Persons Receiving Botulinum Neurotoxin Type A Injections for Upper Extremity Spasticity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Minimum 6 months post injury/insult with unilateral upper limb spasticity of the elbow, wrist and/or finger flexors.
  • Preinjection Modified Ashworth scores > 2 in at least one of the following areas: elbow, wrist, or finger flexors.
  • Subjects must meet criteria for CMA Hand Impairment Scale Stage 2 and be able to complete Task 3 (thumb to index finger) of the CMA Hand Impairment Scale Stage 3, or demonstrate 50% gross grasp to be included.
  • Botulinum toxin A (Botox®) stable patients (have received at least two prior doses of the agent with first dose occurring at least 6 months prior to study enrollment).
  • Able to answer reliably to yes/no questions.
  • Able to follow reliably 1-step instructions.
  • Written informed consent.
  • Females enrolled in this study who are of childbearing age will be required to use adequate measures of birth control for the entire study period. Those who do not agree will be excluded.

Exclusion Criteria:

  • Uncontrolled, clinically significant medical condition other than the condition under evaluation.
  • Severe, fixed joint contracture in the affected arm. Patients with mild contracture that does not significantly impact function will be included based upon the assessment of the PI.
  • Known allergy or sensitivity to any of the components in the study medication.
  • Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
  • Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment.
  • Treatment with botulinum toxin of any serotype for any reason in less than 3 months prior to initial date of injection for the study.
  • Any medical condition that may put the subject at increased risk with exposure to botulinum toxin type A including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function.
  • Evidence of recent alcohol or drug abuse.
  • Infection or skin disorder at an anticipated injection and/or electrical stimulation sites.
  • Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
  • Use of aminoglycoside antibiotics, curare like agents, or other agents that might interfere with neuromuscular function.
  • Individuals with a cardiac pacemaker, a defibrillator, or baclofen pump.
  • Individuals with an unhealed or healing fracture or dislocation in the arm to be evaluated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Individuals randomized into this group will only receive specialized therapy associated with this population.
Experimental: 2
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.
Device: Functional Electrical Stimulation (FES) through the Ness H200
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 Names:
  • NESS H200™ Product Specification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Arm Function Based on Motor Activities Log (MAL-O)
Time Frame: 12 weeks
upper extremity function during activities of daily living based on observer ratings. Scale runs 0 (not used) to 5 (normal function). No subscales used.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Dexterous Hand Function as Measured by the Action Research Arm Test (ARAT)
Time Frame: 12 weeks
Dextrous hand function measurement. Scale ranges from 0 (no dextrous arm function) to 57 (normal function)
12 weeks
Change From Baseline in Self-performance in Activities of Daily Living Assessed With the (MAL - Self Report)
Time Frame: 12 weeks
upper extremity function during activities of daily living as reported by the patient. Scale runs 0 (not used) to 5 (normal function). No subscales used.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

Allergan

Investigators

  • Principal Investigator: Michael C. Munin, M.D., University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

April 17, 2007

First Submitted That Met QC Criteria

April 17, 2007

First Posted (Estimate)

April 19, 2007

Study Record Updates

Last Update Posted (Estimate)

June 20, 2014

Last Update Submitted That Met QC Criteria

June 19, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0611012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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