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

NCT04826900 | Completed Results

• 1 other identifier: NRMPG8J0211
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia, Spastic; Spastic

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Fugl-Meyer Assessment (FMA)

  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).

  Change from baseline at 5 months

• Medical Research Council Scale (MRC)

  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.

  Change from baseline at 5 months

• Modified Ashworth Scale (MAS)

  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.

  Change from baseline at 5 months

• 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).

  Change from baseline at 5 months

• Motor Activity Log (MAL) - Amount of Use Scale (AOU)

  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.

  Change from baseline at 5 months

• Motor Activity Log (MAL) - Quality of Movement Scale (QOM)

  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.

  Change from baseline at 5 months

Study Arms (2)

Robotic Group

EXPERIMENTAL

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.

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

Robotic Mirror Group

EXPERIMENTAL

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.

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

Interventions

BoNT-A injections PROCEDURE

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 Group; Robotic Mirror Group

Robotic therapy (RT) OTHER

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.

Robotic Group

Robotic mirror therapy (RMT) OTHER

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.

Robotic Mirror Group

Functional task training OTHER

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.

Robotic Group; Robotic Mirror Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan

Kaohsiung City, 833, Taiwan

Location

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  PMID: 41152923 DERIVED

MeSH Terms

Conditions

Hemiplegia; Muscle Spasticity

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Results Point of Contact

• Title: Jen-Wen Hung, MD
• Organization: Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan

hung0702@cgmh.org.tw

+886975056689

Study Officials

• Hung Jen-Wen

  Chang Gung Memorial Hospital-Kaohsiung Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 1, 2021
• Study Start: August 1, 2019
• Primary Completion: January 23, 2022
• Study Completion: January 23, 2022
• Last Updated: September 15, 2023
• Results First Posted: June 2, 2023

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)