Botulinum Toxin Type A and Modified Constraint-Induced Movement Therapy for Poststroke Upper Extremity Spasticity

July 29, 2008 updated by: Kaohsiung Veterans General Hospital.

Combined Botulinum Toxin Type A With Modified Constraint-Induced Movement Therapy for Chronic Stroke Patients With Upper Extremity Spasticity

Botulinum toxin type A (BtxA) injection and modified constraint-induced movement therapy (mCIMT) are both promising approaches to enhance recovery after stroke. However, the combined application of the two modalities has rarely been studied. The aim was to investigate whether combined BtxA and mCIMT would produce greater improvements in spasticity and upper extremity function than BtxA plus conventional rehabilitation in chronic stroke patients with upper extremity spasticity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Botulinum toxin type A (BtxA) injection and modified constraint-induced movement therapy (mCIMT)are both promising approaches to enhance recovery after stroke. However, the combined application of the two modalities has rarely been studied. To date, only a single case report addressed this issue. Theoretically, application of a mCIMT program with intensive functional tasks practice after spasticity reduction by BtxA may improve affected upper extremity function in patients with poststroke spasticity. The aim was to investigate whether combined BtxA and mCIMT would produce greater improvements in spasticity and upper extremity function than BtxA plus conventional rehabilitation in chronic stroke patients with upper extremity spasticity.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

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

43 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18 to 80 years
  • at least 1 year after a unilateral stroke
  • modified ashworth scale (MAS) score > 3 in the elbow, wrist or finger flexors
  • ability to actively extend > 10 degrees at metacarpophalangeal and interphalangeal joints and 20 degrees at wrist of the affected upper limb (minimal motor criteria).

Exclusion Criteria:

  • presence of fixed joint contractures
  • serious balance problems
  • preexisting neurological deficits, neuromuscular diseases or uncontrolled medical conditions
  • significant cognitive deficits (Mini-Mental Status Examination score < 24)
  • excessive pain in the affected upper limb
  • previous treatment with Botulinum toxin A, neurolytic agents or surgery for spasticity

All patients were not currently participating in any experimental studies and did not receive concomitant oral anti-spastic medication during the study period

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
BtxA+mCIMT (combination group)
Other: BtxA+mCIMT
The combination group receive BtxA+mCIMT for 2 hours/day, 3 days/week for 3 months.
Other Names:
  • the combination group
Placebo Comparator: 2
BtxA+ conventional rehabilitation (control group)
Other: BtxA+ conventional rehabilitation
The control group received for 2 hours/day, 3 days/week for 3 months.
Other Names:
  • the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome assessed spasticity on the Modified Ashworth Scale.
Time Frame: MAS evaluated before BtxA injection, at 4 weeks, 3 months and 6 months postinjection.
MAS evaluated before BtxA injection, at 4 weeks, 3 months and 6 months postinjection.

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary outcomes assessed real-world arm function (Motor Activity Log), laboratory motor activity (Action Research Arm Test) and patients' global satisfaction.
Time Frame: evaluated before BtxA injection, at 4 weeks, 3 months and 6 months postinjection.
evaluated before BtxA injection, at 4 weeks, 3 months and 6 months postinjection.

Collaborators and Investigators

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

Sponsor

Kaohsiung Veterans General Hospital.

Investigators

  • Principal Investigator: Shu-Fen Sun, MD, Department of Physical Medicine and Rehabilitation

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

December 1, 2005

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

July 25, 2008

First Posted (Estimate)

July 29, 2008

Study Record Updates

Last Update Posted (Estimate)

August 1, 2008

Last Update Submitted That Met QC Criteria

July 29, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGHKS94-087

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.

Clinical Trials on Stroke

Clinical Trials on BtxA+mCIMT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe