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Completed

NCT Number: NCT00723866

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BtxA+mCIMT

Other

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

Other names: the combination group

BtxA+ conventional rehabilitation

Other

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

Other names: the control group

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Jul 29, 2008
Registry last updated
Aug 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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