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

NCT ID: NCT00723866

Last Updated: 2008-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-06-30

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.

Conditions

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Stroke

Keywords

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Botulinum toxin, Spasticity, Stroke, Rehabilitation.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

BtxA+mCIMT (combination group)

Group Type EXPERIMENTAL

BtxA+mCIMT

Intervention Type OTHER

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

2

BtxA+ conventional rehabilitation (control group)

Group Type PLACEBO_COMPARATOR

BtxA+ conventional rehabilitation

Intervention Type OTHER

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

Interventions

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BtxA+mCIMT

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

Intervention Type OTHER

BtxA+ conventional rehabilitation

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

Intervention Type OTHER

Other Intervention Names

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the combination group the control group

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role lead

Responsible Party

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Kaohsiung Veterans General Hospital

Principal Investigators

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Shu-Fen Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Medicine and Rehabilitation

References

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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. doi: 10.2522/ptj.20050262.

Reference Type BACKGROUND
PMID: 17012643 (View on PubMed)

Other Identifiers

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VGHKS94-087

Identifier Type: -

Identifier Source: org_study_id