Status:
COMPLETED
Condensed and Distributed Robotic Therapy in Spastic Stroke Post Botulinum Toxin Injection
Lead Sponsor:
Chang Gung Memorial Hospital
Collaborating Sponsors:
Chang Gung University
Ministry of Science and Technology, Taiwan
Conditions:
Stroke
Hemiplegia, Spastic
Eligibility:
All Genders
18+ 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 between condensed and distributed robot-assisted trainin...
Detailed Description
Patients with spasticity are thought to have greater levels of disability, poorer quality of life, and more caregiver burden than patients without spasticity. Thus, the treatment of spasticity, partic...
Eligibility Criteria
Inclusion
- clinical and imagine diagnosis of a first or recurrent unilateral stroke ≥ 3 months
- 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)
- 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)
- no serious cognitive impairment (i.e., Mini Mental State Exam score \> 20) (Teng \& Chui, 1987)
- age ≥ 18 years
- willing to provide written informed consent
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 4 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 :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03321097
Start Date
October 1 2017
End Date
May 7 2019
Last Update
June 23 2020
Active Locations (1)
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1
Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
Kaohsiung City, Taiwan, 833