Clinical trial NCT03549975: Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation-pilot Study
Official title: Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation Among Stroke Patients With Limitation of Finger Extension Due to Spasticity- Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke
Spastic Hemiparesis
Spasticity as Sequela of Stroke
Keywords: stroke
hand
botulinum toxin
functional electrical stimulation
Lead sponsor: National Rehabilitation Center, Seoul, Korea
Sponsor class: OTHER_GOV
First posted: 2018-06-08
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Box and Block test
timeFrame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
measure: Change of Action Research Arm Test
timeFrame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Secondary outcomes:
measure: Muscle strength of finger extensor
timeFrame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
measure: Spasticity of finger extensor
timeFrame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
measure: active range of motion of wrist joint
timeFrame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
measure: Brunnstrom stage of stroke recovery of distal upper extremity
timeFrame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
measure: Distance from middle finger tip to mid-palmar crease
timeFrame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
measure: Repeated number of finger extension and flexion
timeFrame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
measure: Quick Disabilities of Arm, Shoulder & Hand
timeFrame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
measure: Grading of active thumb opposition
timeFrame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
measure: Grip strength
timeFrame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
measure: Active finger extension
timeFrame: baseline, 2 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Other outcomes:
Locations:
Study officials:
affiliation: National Rehabilitation Center of Korea
name: Joon-Ho Shin, MS
role: PRINCIPAL_INVESTIGATOR
References: