Wearable Robotic System and Robotic Mirror Therapy in Spastic Hemiplegia Post Botulinum Toxin Injection

Chang Gung Medical Foundation

Status: Completed

Conditions: Spastic; Hemiplegia, Spastic

Treatments: Other: Robotic mirror therapy (RMT); Other: Robotic therapy (RT); Other: Functional task training; Procedure: BoNT-A injections

Study type: Interventional

Funder types: Other

Identifiers

NCT04826900

NRMPG8J0211

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 2 patient groups

Robotic Group

Experimental group

Description:

Training session included 45 minutes Robotic Therapy, followed by 15-minute functional training. The robotic group will receive 3 sessions per week, for 8 weeks.

Treatment:

Other: Functional task training

Other: Robotic therapy (RT)

Procedure: BoNT-A injections

Robotic Mirror Group

Experimental group

Description:

Training session included 45 minutes Robotic Mirror Therapy, followed by 15-minute functional training. The robotic group will receive 3 sessions per week, for 8 weeks.

Treatment:

Other: Robotic mirror therapy (RMT)

Other: Functional task training

Procedure: BoNT-A injections