Clinical trial NCT03807557: Robotic Modified Constraint -Induced Therapy in Patients With Spastic Hemiplegic Stroke Post Botulinum Toxin A Injection
Official title: Effects of Robotic Modified Constraint -Induced Therapy on Behavioral Outcomes and Motor-learning Process in Patients With Spastic Hemiplegic Stroke Post Botulinum Toxin Type A Injection: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiplegia, Spastic
Keywords: Stroke rehabilitation
Botulinum toxin type A injection
robot-assisted therapy
Constraint-induced movement therapy
spasticity
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Chang Gung University
First posted: 2019-01-17
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 before, after intervention, and 3 months post-intervention. Investigators will also monitor the kinematic data of InMotion 3.0 robot across the whole course of Robotic mCIMT to see how the Robotic mCIMT following BoNT-A injection impacts motor learning process of the participants.

Analysis: To evaluate the treatment effects of the outcome measures, 2 groups (Robotic mCIMT or control) \* 3 times (before intervention, after intervention, and 3 months after intervention) repeated-measure ANOVA will be used.


Eligibility criteria: Inclusion Criteria:

* (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 Criteria:

* 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.

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: Change from baseline at 1.5 months
measure: Modified Ashworth Scale
timeFrame: Change from baseline at 1.5 months
measure: Actigraph
timeFrame: Change from baseline at 1.5 months
measure: Wolf Motor Function Test (WMFT)
timeFrame: Change from baseline at 1.5 months
Secondary outcomes:
measure: Motor Activity Log (MAL)
timeFrame: Change from baseline at 1.5 months
measure: Nottingham Extended Activities of Daily Living Scale (NEADL)
timeFrame: Change from baseline at 1.5 months
measure: Goal attainment scale (GAS)
timeFrame: Change from baseline at 1.5 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Jen-Wen Hung
role: PRINCIPAL_INVESTIGATOR
References: