Clinical trial NCT04826900: Wearable Robotic System and Robotic Mirror Therapy in Spastic Hemiplegia Post Botulinum Toxin Injection
Official title: A Randomized Control Trial to Compare the Effects Between Wearable Robotic System and Robotic Mirror Therapy in Patients With Spastic Hemiplegia Post Botulinum Toxin Injection: Neurophysiological and Behavior Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia, Spastic
Spastic
Keywords: Stroke rehabilitation
Spasticity
Botulinum toxin type A injection
Mirror therapy
Robot
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 31
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: 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 therapy (RMT) in patients with spastic hemiplegic stroke.

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 functional recovery of patients with spastic hemiplegic stroke.

Patients with spasticity usually have lower motor function and worse sensory deficits than patients without spasticity. Designing the post BoNT-A injection rehabilitation program should consider the above issues. RT and MT are two interventions providing sensorimotor input for patient with low motor function. Combining both approaches (wearing robotic hand to do mirror therapy) might facilitate the sensorimotor cortex that controls movement and might augment somatosensory input and further treatment efficacy. It is unknown whether and how combining BoNT injection with bilateral RT vs with MT vs with RMT engenders differential effects on motor and related functional performance in patients with spastic hemiplegic stroke.

Forty-eight participants with chronic spastic hemiplegic stroke will be recruited and randomly assigned to one of 2 groups: RT, and RMT. All the post- injection interventions will be implemented 60 minutes/day, 3 days/week, for 8 weeks. At each training session all patients will receive 45-minute RT, or RMT, then 15-minute functional task training.

The outcome measures include 1) body function and structures: Fugl-Meyer Assessment, Modified Ashworth Scale, Medical Research Council scale, 2) activity and participation: Box and block test, Motor Activity Log, and Nottingham Extended Activities of Daily Living Scale, Action Research Arm Test. In addition, to directly reflect a patient's unique needs and goals, Goal Attainment Scaling will be assessed. Electroencephalography (EEG) and functional near infrared reflectance spectroscopy (NIRS) assessments will be done to assess the neurophysiologic effects of the 3 kinds of intervention. The outcome will be measured at pre-treatment,1-week after BoNT-A injection, post-treatment, and 3-month follow- up.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: Change from baseline at 5 months
measure: Medical Research Council Scale (MRC)
timeFrame: Change from baseline at 5 months
measure: Modified Ashworth Scale (MAS)
timeFrame: Change from baseline at 5 months
measure: Box and Block Test (BBT)
timeFrame: Change from baseline at 5 months
measure: Motor Activity Log (MAL) - Amount of Use Scale (AOU)
timeFrame: Change from baseline at 5 months
measure: Motor Activity Log (MAL) - Quality of Movement Scale (QOM)
timeFrame: Change from baseline at 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
Study officials:
affiliation: Chang Gung Memorial Hospital-Kaohsiung Medical Center
name: Hung Jen-Wen
role: PRINCIPAL_INVESTIGATOR
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