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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Stroke	Other: BtxA+mCIMT; Other: BtxA+ conventional rehabilitation	Not Applicable

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	32 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Combined Botulinum Toxin Type A With Modified Constraint-Induced Movement Therapy for Chronic Stroke Patients With Upper Extremity Spasticity
Study Start Date :	December 2005
Actual Primary Completion Date :	November 2007
Actual Study Completion Date :	June 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: the control group

Outcome Measures

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Primary Outcome Measures :

1. 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. ]

Secondary Outcome Measures :

1. 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. ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	45 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Kaohsiung Veterans General Hospital.

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
ClinicalTrials.gov Identifier:	NCT00723866 History of Changes
Other Study ID Numbers:	VGHKS94-087
First Posted:	July 29, 2008
Last Update Posted:	August 1, 2008
Last Verified:	July 2008

Keywords provided by Kaohsiung Veterans General Hospital.:

Botulinum toxin, Spasticity, Stroke, Rehabilitation.

Additional relevant MeSH terms:

Stroke; Muscle Spasticity; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations	Signs and Symptoms; Botulinum Toxins; Botulinum Toxins, Type A; onabotulinumtoxinA; abobotulinumtoxinA; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents