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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: BtxA+mCIMT; Other: BtxA+ conventional rehabilitation

• Registration Number: NCT00723866
• Lead Sponsor: Kaohsiung Veterans General Hospital.

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.

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 Timeline

• Study Start: 2005-12
• Primary Completion: 2007-11
• Study Completion: 2008-06
• Status Verified: 2008-07
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-29
• Last Update Submitted: 2008-07-29
• Last Update Posted: 2008-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	BtxA+mCIMT	BtxA+mCIMT (combination group)
2	BtxA+ conventional rehabilitation	BtxA+ conventional rehabilitation (control group)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.