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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Other: BtxA+mCIMT
* Other: BtxA+ conventional rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>BtxA+mCIMT (combination group) | Other: BtxA+mCIMT<br>* The combination group receive BtxA+mCIMT for 2 hours/day, 3 days/week for 3 months.<br>* Other names: the combination group;|
| Placebo Comparator: 2<br>BtxA+ conventional rehabilitation (control group) | Other: BtxA+ conventional rehabilitation<br>* The control group received for 2 hours/day, 3 days/week for 3 months.<br>* Other names: the control group;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botulinum toxin, Spasticity, Stroke, Rehabilitation.