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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723866
• Other study ID #: VGHKS94-087
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: July 29, 2008
• Start date: December 2005
• Est. completion date: June 2008

Study information

• Verified date: July 2008
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Spasticity
• Stroke

Intervention

Other:
• BtxA+mCIMT
The combination group receive BtxA+mCIMT for 2 hours/day, 3 days/week for 3 months.
• BtxA+ conventional rehabilitation
The control group received for 2 hours/day, 3 days/week for 3 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome assessed spasticity on the Modified Ashworth Scale.		MAS evaluated before BtxA injection, at 4 weeks, 3 months and 6 months postinjection.	Yes
Secondary	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.	Yes