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

This study has been completed.
Sponsor:
Information provided by:
Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT00723866
First received: July 25, 2008
Last updated: July 29, 2008
Last verified: July 2008
History of Changes
  Purpose

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.


Condition Intervention
Stroke
 Other: BtxA+mCIMT
Other: BtxA+ conventional rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Botulinum Toxin Type A With Modified Constraint-Induced Movement Therapy for Chronic Stroke Patients With Upper Extremity Spasticity

Resource links provided by NLM:

MedlinePlus related topics: Botox Rehabilitation
U.S. FDA Resources

Further study details as provided by Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
Enrollment: 32
Study Start Date: December 2005
Study Completion Date: June 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
BtxA+mCIMT (combination group)
 Other: BtxA+mCIMT
The combination group receive BtxA+mCIMT for 2 hours/day, 3 days/week for 3 months.
Other Name: the combination group
Placebo Comparator: 2
BtxA+ conventional rehabilitation (control group)
 Other: BtxA+ conventional rehabilitation
The control group received for 2 hours/day, 3 days/week for 3 months.
Other Name: the control group

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.

  Eligibility
Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723866

Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
Principal Investigator: Shu-Fen Sun, MD Department of Physical Medicine and Rehabilitation
  More Information

Publications:

Responsible Party: Kaohsiung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT00723866     History of Changes
Other Study ID Numbers: VGHKS94-087
Study First Received: July 25, 2008
Last Updated: July 29, 2008
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Veterans General Hospital.:
Botulinum toxin, Spasticity, Stroke, Rehabilitation.

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
 Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015