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

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ClinicalTrials.gov Identifier: NCT00723866
Recruitment Status : Completed
First Posted : July 29, 2008
Last Update Posted : August 1, 2008
Sponsor:
Information provided by:
Kaohsiung Veterans General Hospital.

Study Description
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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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Rehabilitation

Arms and Interventions
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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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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723866


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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Publications:

Responsible Party: Kaohsiung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT00723866     History of Changes
Other Study ID Numbers: VGHKS94-087
First Posted: July 29, 2008    Key Record Dates
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