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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04826900

Enrollment

Registered

2021-04-01

Start date

2019-08-01

Completion date

2022-01-23

Last updated

2023-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiplegia, Spastic, Spastic

Keywords

Stroke rehabilitation, Spasticity, Botulinum toxin type A injection, Mirror therapy, Robot

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.

Interventions

PROCEDUREBoNT-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

OTHERRobotic 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.

OTHERRobotic 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.

OTHERFunctional 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

There will be a research code representing patients' identity, this code will not show patients' name, social security number, and home address. For the results of patients' visit and the diagnosis, the study moderator will maintain a confidential attitude and be careful to maintain patients' privacy.

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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).
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.
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.
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.

Countries

Taiwan

Participant flow

Participants by arm

Arm	Count
Robotic Group 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. BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, 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 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. Functional task training: After either 45 minutes of RT or RMT, all participants receive 15 minutes of training in functional tasks. The functional tasks training will be bases on the needs and ability of patients.	14
Robotic Mirror Group 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. 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 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. Functional task training: After either 45 minutes of RMT, all participants receive 15 minutes of training in functional tasks.The functional tasks training will be bases on the needs and ability of patients.	15
Total	29

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Family factor	1	1

Baseline characteristics

Characteristic	Robotic Group	Robotic Mirror Group	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	1 Participants	1 Participants
Age, Categorical Between 18 and 65 years	14 Participants	14 Participants	28 Participants
Age, Continuous	47.07 years STANDARD_DEVIATION 10.36	48.60 years STANDARD_DEVIATION 9.65	47.86 years STANDARD_DEVIATION 9.85
Race/Ethnicity, Customized Asian	14 Participants	15 Participants	29 Participants
Region of Enrollment Taiwan	14 participants	15 participants	29 participants
Sex: Female, Male Female	6 Participants	7 Participants	13 Participants
Sex: Female, Male Male	8 Participants	8 Participants	16 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

Box and Block Test (BBT)

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).