Status:
RECRUITING
Exoskeleton Robotic Assisted Gait Training in Spastic Stroke Post Botulinum Toxin a Injection
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Spastic Gait
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 exoskeleton Robotic assisted gait training (RABT) in...
Detailed Description
The aim of the study is to evaluate the effects of BoNT-A combining with overground exoskeleton robot for patients with post-stroke stiff-knee gait. Stiff-knee gait (SKG) is a common gait pattern in ...
Eligibility Criteria
Inclusion
- Ischemic or hemorrhagic stroke ≥ 3 months
- Age ≥ 20 years
- Functional Ambulation Category ≥4
- Affected rectus femoris spasticity (MAS between 1+ and 2)
- BoNT-A treatment-naive or treated with BoNT-A ≥4 months in the affected leg before recruitment
- Receiving oral muscle relaxants or other medication for spasticity were on a stable dose for≥2 months
- Can obey simple order
Exclusion
- Pregnant
- Sensitivity to BoNT-A
- Infection of the skin, soft tissue in the injection area
- Participation in other trials
- Fixed contractures or bony deformities in the affected leg
- Previous treatment of the affected leg with neurolytic or surgical procedures (i.e., phenol block, tendon lengthening of transfer, tenotomy, muscle release, arthrodesis)
- Severe cardiovascular comorbidity (i.e., recent myocardial infarction, heart failure, uncontrolled hypertension, orthostatic hypotension)
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06070987
Start Date
August 1 2023
End Date
July 31 2025
Last Update
February 14 2025
Active Locations (1)
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1
Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
Kaohsiung City, Kaohsiung, Taiwan, 833