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

NCT00723866 | Completed DMC

• 1 other identifier: VGHKS94-087
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke

Keywords

Botulinum toxin, Spasticity, Stroke, Rehabilitation.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

1

EXPERIMENTAL

BtxA+mCIMT (combination group)

Other: BtxA+mCIMT

2

PLACEBO COMPARATOR

BtxA+ conventional rehabilitation (control group)

Other: BtxA+ conventional rehabilitation

Interventions

BtxA+mCIMT OTHER

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

Also known as: the combination group

1

BtxA+ conventional rehabilitation OTHER

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

Also known as: the control group

2

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Related 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. doi: 10.2522/ptj.20050262.

  PMID: 17012643 BACKGROUND

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shu-Fen Sun, MD

  Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: December 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: June 1, 2008
• Last Updated: August 1, 2008

Record last verified: 2008-07