NCT04826900

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemiplegia, Spastic
• Spastic

Interventions

Type	Name	Description
PROCEDURE	BoNT-A injections	Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 200 units to 500 units. The dose range of each target muscle is as below: 20 and 75 units for flexor carpi ulnaris and flexor carpi radials; 12.5-35 units per fascicle in the flexor digitorum sublimis and flexor digitorum profundus (maximum dose: 120 units for each of these muscles); 10-35 units in the flexor pollicis longus; 25-100 units in the brachioradial ; 50-200 units in the biceps brachii; and 25-75 units in the pronator teres
OTHER	Robotic therapy (RT)	A wearable robotic hand system will be used in this study. The robotic hand system consisted with a wearable exoskeletal hand, sensor glove, and a control box. On the exoskeletal hand, there are five actuators on each of finger structure that can provide external power to bring individual finger moving. The sensor glove has five sensors that can detect the finger's posture during movement and then manipulates exoskeletal hand via the control box. The patient's unaffected hand wears the sensor glove, the affected hand wears the wearable exoskeleton hand, and the unaffected hand does the certain transitive and intransitive tasks as the mirror group, and then makes the affected hand do the same movements driven by the exoskeleton robotic hand.
OTHER	Robotic mirror therapy (RMT)	Wearable robotic hand system and mirror system will be used in this group.. The patients in the group will wear the robotic hand to do the mirror therapy. The patient's unaffected hand wears the sensor glove, the affected hand wears the wearable exoskeletal hand, a mirror box with a mirror will be placed in the patient 's midsagittal plane beside the unaffected hand to block his or her view of the affected hand. The patient's unaffected hand does the certain transitive and intransitive tasks and the patient will be instructed to look at the reflection of the unaffected hand in the mirror as if it is the affected hand (the visual input). At the same time the affected hand will be passively moved by the exoskeleton robotic hand which is under the .control of the unaffected hand.
OTHER	Functional task training	After either 45 minutes of RT or RMT, all participants receive 15 minutes of training in functional tasks. The functional tasks included taking up and holding bowl or using eating utensils , bringing a cup for drinking, drying sucks by clips, open ing or closing door , turning on or off the light, cleaning the table or window and so on . The functional tasks training will be bases on the needs and ability of patients.

Timeline

• Start date: 2019-08-01
• Primary completion: 2022-01-23
• Completion: 2022-01-23
• First posted: 2021-04-01
• Last updated: 2023-09-15
• Results posted: 2023-06-02

Locations

1 site across 1 country: Taiwan