Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation-pilot Study

Study Overview
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Brief Summary
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The investigator tried to find out possibility of functional improvement using botulinum toxin injection targeting finger flexor spasticity with functional electrical stimulation among chronic stroke patients who did not show any improvement in hand function.

Official Title
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Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation Among Stroke Patients With Limitation of Finger Extension Due to Spasticity- Pilot Study

Conditions
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Stroke, Spastic Hemiparesis, Spasticity as Sequela of Stroke

Intervention / Treatment
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* Drug: Botulinum Toxin Type A 100 unit/Vial (Product)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 18 years hemiplegic upper limb spasticity secondary to a unilateral ischemic or hemorrhagic stroke fingers and wrist flexor spasticity graded at least 1+ on the Modified Ashworth Scale at least 6 months since stroke Exclusion Criteria: fixed contracture previous treatment of the upper limb spasticity with neurolytic or surgical procedure treatment with botulinum toxin type A in the previous 4 months any active device implant any neurological disorder, other than stroke causing motor deficits or spasticity inability to attend to and/or to cooperate with all outcome measure-related task secondary to cognitive impairment or aphasia pregnancy, planned pregnancy, or lactation contraindication to botulinum toxin type A

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin type A injection<br>Botulinum toxin type A injection followed by functional electrical stimulation | Drug: Botulinum Toxin Type A 100 unit/Vial (Product)<br>* Botulinum toxin type A injection followed by functional electrical stimulation<br>* Other names: functional electrical stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Box and Block test | number of box moved by affected upper extremity | baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline | 
| Change of Action Research Arm Test | Score of Action Research Arm Test | baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength of finger extensor | Medical research council grading of muscle strength | baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline | 
| Spasticity of finger extensor | Modified ashworth scale of finger flexor | baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline | 
| active range of motion of wrist joint | active range of motion of wrist joint | baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline | 
| Brunnstrom stage of stroke recovery of distal upper extremity | Brunnstrom stage of stroke recovery of distal upper extremity. By observing the pattern of participants posture, the stage was scored. The stage ranges from 1 to 6. Higher is better. | baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline | 
| Distance from middle finger tip to mid-palmar crease | Distance from middle finger tip to mid-palmar crease | baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline | 
| Repeated number of finger extension and flexion | Repeated number of finger extension and flexion | baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline | 
| Quick Disabilities of Arm, Shoulder & Hand | Quick Disabilities of Arm, Shoulder & Hand is questionnaire about patients' symptoms as well as ability to perform certain activities in the last week. Total score is obtained by summing the each question, and ranges from 0 (no disability) to 100 (most severe disability). | baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline | 
| Grading of active thumb opposition | Grading of active thumb opposition. It is measured by observing the pattern of thumb opposition. | baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline | 
| Grip strength | measured by Jamar dynamometer | baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline | 
| Active finger extension | Active finger extension. It is graded by observation of voluntary finger extension. | baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, hand, botulinum toxin, functional electrical stimulation