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

Kaohsiung Veterans General Hospital.32 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke

Interventions

BtxA+mCIMTOTHER

The combination group receive BtxA+mCIMT for 2 hours/day, 3 days/week for 3 months.

BtxA+ conventional rehabilitationOTHER

The control group received for 2 hours/day, 3 days/week for 3 months.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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