Status:
COMPLETED
Robotic Modified Constraint -Induced Therapy in Patients With Spastic Hemiplegic Stroke Post Botulinum Toxin A Injection
Lead Sponsor:
Chang Gung Memorial Hospital
Collaborating Sponsors:
Chang Gung University
Conditions:
Stroke
Hemiplegia, Spastic
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
Background and purpose: Botulinum toxin A (BoNT-A) injection is effective in reducing spasticity. However, the optimal training program post BoNT-A injection remains uncertain. Constraint-induced move...
Eligibility Criteria
Inclusion
- (1) clinical and imagine diagnosis of a first or recurrent unilateral stroke ≥ 3 months; (2) upper limb spasticity (modified Ashworth scale of ≥ 1+ for elbow flexor and/or forearm pronator and/or finger flexor muscles and/or wrist flexor muscles (Bohannon \& Smith, 1987); (3) initial motor part of UE of FMA score ranging from 17 to 56, indicating moderate to severe movement impairment (Duncan, Goldstein, Matchar, Divine, \& Feussner, 1992; Fugl Meyer, Jaasko, \& Leyman, 1975; Park, Wolf, Blanton, Winstein, \& Nichols-Larsen, 2008); (4) no serious cognitive impairment (i.e., Mini Mental State Exam score \> 20) (Teng \& Chui, 1987); (5) age ≥ 20 years ; and (6) willing to provide written informed consent.
Exclusion
- 1\. pregnant 2. with bilateral hemispheric or cerebellar lesions 3. sever aphasia 4. significant visual field deficits or hemineglect 5. contraindication for BoNT-A injection 6. treatment with BoNT-A within 4 months before recruitment 7. any fixed joint contracture of the affected upper limb 8. a history of orthopedic or other neurological diseases and/or medical conditions that would prevent adherence to the rehabilitation protocol.
Key Trial Info
Start Date :
January 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03807557
Start Date
January 30 2019
End Date
December 30 2019
Last Update
July 29 2021
Active Locations (1)
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1
Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center
Kaohsiung City, Taiwan