Status:
COMPLETED
Wearable Robotic System and Robotic Mirror Therapy in Spastic Hemiplegia Post Botulinum Toxin Injection
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Hemiplegia, Spastic
Spastic
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
The purpose of this project is to examine and compare the immediate and long-term effects of combined Botulinum toxin type A(BoNT-A) injection with wearable robotic hand system (RT) and Robotic mirror...
Detailed Description
Spasticity, a common impairment after stroke, has a profound impact on activity and participation for patients. BoNT-A injection combined with rehabilitation training is recommended to enhance functio...
Eligibility Criteria
Inclusion
- Clinical and imagine diagnosis of a first or recurrent unilateral stroke ≥ 3 months
- Finger flexor muscles spasticity (modified Ashworth scale of ≥ 1+)
- Initial motor part of UE of FMA score ranging from 10 to 56 indicating moderate to severe movement impairment
- No serious cognitive impairment (i.e., Mini Mental State Exam score \> 20)
- Age ≥ 20 years
Exclusion
- Pregnant
- With bilateral hemispheric or cerebellar lesions
- Sever aphasia
- Significant visual field deficits or hemineglect
- Contraindication for BoNT-A injection
- Treatment with BoNT-A within 6 months before recruitment
- Any fixed joint contracture of the affected upper limb
- 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 :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04826900
Start Date
August 1 2019
End Date
January 23 2022
Last Update
September 15 2023
Active Locations (1)
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1
Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
Kaohsiung City, Taiwan, 833