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

Sponsored by:	Kaohsiung Veterans General Hospital.
Information provided by:	Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:	NCT00723866

Purpose

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.

Condition	Intervention
Stroke	Other: BtxA+mCIMT Other: BtxA+ conventional rehabilitation

MedlinePlus related topics: Botox Rehabilitation

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Combined Botulinum Toxin Type A With Modified Constraint-Induced Movement Therapy for Chronic Stroke Patients With Upper Extremity Spasticity

Further study details as provided by Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]

Enrollment:	32
Study Start Date:	December 2005
Study Completion Date:	June 2008
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental BtxA+mCIMT (combination group)	Other: BtxA+mCIMT The combination group receive BtxA+mCIMT for 2 hours/day, 3 days/week for 3 months.
2: Placebo Comparator BtxA+ conventional rehabilitation (control group)	Other: BtxA+ conventional rehabilitation The control group received for 2 hours/day, 3 days/week for 3 months.

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.

Eligibility

Ages Eligible for Study:	45 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723866

Sponsors and Collaborators

Kaohsiung Veterans General Hospital.

Investigators

Principal Investigator:

Shu-Fen Sun, MD

Department of Physical Medicine and Rehabilitation

More Information

Publications:

Sun SF, Hsu CW, Hwang CW, Hsu PT, Wang JL, Yang CL. Application of combined botulinum toxin type A and modified constraint-induced movement therapy for an individual with chronic upper-extremity spasticity after stroke. Phys Ther. 2006 Oct;86(10):1387-97.

Responsible Party:	Kaohsiung Veterans General Hospital ( Kaohsiung Veterans General Hospital )
Study ID Numbers:	VGHKS94-087
Study First Received:	July 25, 2008
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00723866
Health Authority:	Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Veterans General Hospital.:

Botulinum toxin, Spasticity, Stroke, Rehabilitation.

Study placed in the following topic categories:

Muscle Spasticity
Botulinum Toxins
Cerebral Infarction
Stroke
Vascular Diseases

Central Nervous System Diseases
Botulinum Toxin Type A
Brain Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:

Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Neuromuscular Agents

Cardiovascular Diseases
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009