MedTrace Logo

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

NCT00462449 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2014-06-20

Study results available
· View outcomes & findings →

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.

Conditions

  • Upper Extremity Spasticity
  • Stroke
  • Acquired Brain Injury

Interventions

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.

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Michael C. Munin, M.D. · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00462449 on ClinicalTrials.gov