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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00723866

Enrollment

Registered

2008-07-29

Start date

2005-12-31

Completion date

2008-06-30

Last updated

2008-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Botulinum toxin, Spasticity, Stroke, Rehabilitation.

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.

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.

Interventions

OTHERBtxA+mCIMT

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

OTHERBtxA+ conventional rehabilitation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026