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

Not Applicable

Completed

Conditions: Spastic
Hemiplegia, Spastic

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

Registration Number: NCT04826900

Lead Sponsor: Chang Gung Memorial Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 31

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic Group	BoNT-A injections	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.
Robotic Group	Functional task training	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.
Robotic Mirror Group	Robotic mirror therapy (RMT)	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.
Robotic Group	Robotic therapy (RT)	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.
Robotic Mirror Group	Functional task training	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.
Robotic Mirror Group	BoNT-A injections	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.

Primary Outcome Measures

Name	Time	Method
Medical Research Council Scale (MRC)	Change from baseline at 5 months	The MRC scale will be used to examine the muscle strength of the affected arm (Medical Research Council, 1976). The MRC scale is a reliable measurement which ranges from 0 (no contraction) to 5 (normal power). The muscle strength will be measured at the shoulder flexor/abductor, elbow flexors/extensors, wrist flexors/extensors, and finger flexors/extensors by using the MRC in this project. Total scale combines all range and computes average scores. Flexor scale combines elbow flexors, wrist flexors, fingers flexors and computes average scores. Proximal scale combines shoulder flexor/abductor, elbow flexors/extensors, and computes average scores. Distal scale combines wrist flexors/extensors, and finger flexors/extensors. The higher scores mean a better outcome.
Fugl-Meyer Assessment (FMA)	Change from baseline at 5 months	Fugl-Meyer Assessment for Upper Extremity (FMA-UE): The FMA-UE was used to assess the patient's reflexes, movements, and coordination of upper limbs. It consists of 33 items scored on a 3-point ordinal scale (0, cannot perform; 1, performs partially; 2, performs fully). (Fugl-Meyer, Jääskö, Leyman, Olsson, \& Steglind, 1975) . The total score ranges from 0 to 66, and a higher score indicates better motor function. Satisfactory psychometric properties of the FMA have been demonstrated. (Thomas Platz et al., 2005).
Box and Block Test (BBT)	Change from baseline at 5 months	The BBT, which evaluates manual dexterity of the paretic UE, uses a wooden box that has two equally sized compartments. Cubes were placed in one compartment, and the participants were instructed to move the cubes to the other compartment one by one and as quickly as possible within 60 seconds. The score was determined by calculating the number of cubes carried across the partition. The BBT has high test-retest reliability in participants with stroke(Thomas Platz et al., 2005).
Motor Activity Log (MAL) - Amount of Use Scale (AOU)	Change from baseline at 5 months	The MAL is a semi-structured interview to rate how much \[amount of use scale (AOU)\] they use their affected upper extremity in 30 daily activities using a 6-point scale. Higher scores represent better performance. The MAL has established reliability, validity, and responsiveness in patients with stroke. The MAL will be used to measure daily use of the affected upper limb in daily life in this project.The total score ranges from 0 to 30.
Motor Activity Log (MAL) - Quality of Movement Scale (QOM)	Change from baseline at 5 months	The MAL is a semi-structured interview to rate how well \[quality of movement scale (QOM)\] they use their affected upper extremity in 30 daily activities using a 6-point scale. Higher scores represent better performance. The MAL has established reliability, validity, and responsiveness in patients with stroke. The MAL will be used to measure daily use of the affected upper limb in daily life in this project.The total score ranges from 0 to 30.
Modified Ashworth Scale (MAS)	Change from baseline at 5 months	Spasticity of skeletal muscle in upper extremity was evaluated by using the MAS scale. It uses a 8-point scale(0, 1, 1.5, 2, 2.5, 3, 3.5, 4) to score the average resistance to passive movement for each join with higher score indicating higher spasticity. The MAS has shown good reliability and validity. We assessed the MAS of shoulder flexor/extensor/abductor/adductor, elbow flexors/extensors, forearm pronator/supinator, wrist flexors/extensors, and finger flexors/extensors in this project. Total scale combines all range and computes average scores. Flexor scale combines elbow extensor, wrist extensor, fingers extensor and computes average scores. Proximal scale combines shoulder flexor/extensor/abductor/adductor, elbow flexors/extensors and computes average scores. Distal scale combines forearm pronator/supinator, wrist flexors/extensors, and finger flexors/extensors. The maximum of MAS scale is 4, and the minimum is 0. The higher scores mean a worse outcome.