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Robotic Modified Constraint -Induced Therapy in Patients With Spastic Hemiplegic Stroke Post Botulinum Toxin A Injection
NCT03807557 · Chang Gung Memorial Hospital · Updated 29 July 2021
- What is being tested
- Robotic Constraint-induced movement therapy; conventional UE rehabilitation training
- For
- Stroke; Hemiplegia, Spastic
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 20 years and older. About 18 people. The full rules are on the registry page.
- Where
- Taiwan
- When
- Starts or started 30 Jan 2019, ends 30 Dec 2019. Registered 17 Jan 2019.
- Results
- None posted yet.
In the researchers' words
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 movement therapy (CIMT) is the most investigated intervention with promising effects for improving upper extremity (UE) function and increasing use frequency of the affected limb in ADL. The CIMT has strict inclusion criteria, which might not be suitable for a majority of patients who have moderate to severe spasticity. The aims of this study are to compare the effect of Robotic mCIMT with conventional upper extremity rehabilitation training in patient with spastic hemiplegia post BoNT-A injection. Methods: Those patients with spastic hemiplegic stroke will receive BoNT-A injection and then be randomly assigned to either Robotic mCIMT group (1 hour unilateral robotic therapy, followed by 30 minutes of functional practice of affected UE using shaping technique, 3/week for 8 weeks and restraint of the unaffected limb at home for 2 hrs per day ) or control group (conventional upper extremity rehabilitation training 1.5 hours per session, 3/week for 8 weeks and home exercise 2 hrs per day). Body function and structures outcome measures, such as Fugl-Meyer Assessment, Actigraph ; activity and participation measures, such as Wolf Motor Function Test, Motor Activity Log, will be assessed…
Sites
- Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical CenterKaohsiung City, Taiwan
