Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation-pilot Study
- Conditions
- Spastic HemiparesisStrokeSpasticity as Sequela of Stroke
- Interventions
- Drug: Botulinum Toxin Type A 100 unit/Vial (Product)
- Registration Number
- NCT03549975
- Lead Sponsor
- National Rehabilitation Center, Seoul, Korea
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Botulinum toxin type A injection Botulinum Toxin Type A 100 unit/Vial (Product) Botulinum toxin type A injection followed by functional electrical stimulation
- Primary Outcome Measures
Name Time Method Change in Box and Block test baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline number of box moved by affected upper extremity
Change of Action Research Arm Test baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline Score of Action Research Arm Test
- Secondary Outcome Measures
Name Time Method Muscle strength of finger extensor baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline Medical research council grading of muscle strength
Brunnstrom stage of stroke recovery of distal upper extremity baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline 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.
Repeated number of finger extension and flexion baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline Repeated number of finger extension and flexion
Spasticity of finger extensor baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline Modified ashworth scale of finger flexor
active range of motion of wrist joint baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline active range of motion of wrist joint
Distance from middle finger tip to mid-palmar crease baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline Distance from middle finger tip to mid-palmar crease
Grading of active thumb opposition baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline Grading of active thumb opposition. It is measured by observing the pattern of thumb opposition.
Grip strength baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline measured by Jamar dynamometer
Quick Disabilities of Arm, Shoulder & Hand baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline 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).Active finger extension baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline Active finger extension. It is graded by observation of voluntary finger extension.