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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00723866
• Date of registration: 25/07/2008
• Prospective Registration: No
• Primary sponsor: Kaohsiung Veterans General Hospital.
• Public title: Botulinum Toxin Type A and Modified Constraint-Induced Movement Therapy for Poststroke Upper Extremity Spasticity
• Scientific title: Combined Botulinum Toxin Type A With Modified Constraint-Induced Movement Therapy for Chronic Stroke Patients With Upper Extremity Spasticity
• Date of first enrolment: December 2005
• Target sample size: 32
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00723866
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Contacts

• Name: Shu-Fen Sun, MD
• Affiliation: Department of Physical Medicine and Rehabilitation

Key inclusion & exclusion 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



Age minimum: 45 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Stroke

Intervention(s)

Other: BtxA+ conventional rehabilitation

Other: BtxA+mCIMT

Primary Outcome(s)

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 Outcome(s)

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.]

Secondary ID(s)

VGHKS94-087

Source(s) of Monetary Support

Please refer to primary and secondary sponsors