Spastic Hemiparesis, Spasticity as Sequela of Stroke, Stroke
Conditions
Keywords
stroke, hand, botulinum toxin, functional electrical stimulation
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.
Interventions
DRUGBotulinum Toxin Type A 100 unit/Vial (Product)
Botulinum toxin type A injection followed by functional electrical stimulation
Sponsors
National Rehabilitation Center, Seoul, Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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 |
| 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 |
| 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 |
| 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. |
| 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). |
| Spasticity of finger extensor | baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline | Modified ashworth scale of finger flexor |
Outcome results
None listed