Robotic Modified Constraint -Induced Therapy in Patients With Spastic Hemiplegic Stroke Post Botulinum Toxin A Injection

NCT ID: NCT03807557

Last Updated: 2021-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-30
• Study Completion Date: 2019-12-30

Brief Summary

Background and purpose: Botulinum toxin A (BoNT-A) injection is effective in reducing spasticity. However, the optimal training program post BoNT-A injection remains uncertain. Constraint-induced movement therapy (CIMT) is the most investigated intervention with promising effects for improving upper extremity (UE) function and increasing use frequency of the affected limb in ADL. The CIMT has strict inclusion criteria, which might not be suitable for a majority of patients who have moderate to severe spasticity. The aims of this study are to compare the effect of Robotic mCIMT with conventional upper extremity rehabilitation training in patient with spastic hemiplegia post BoNT-A injection.

Methods: Those patients with spastic hemiplegic stroke will receive BoNT-A injection and then be randomly assigned to either Robotic mCIMT group (1 hour unilateral robotic therapy, followed by 30 minutes of functional practice of affected UE using shaping technique, 3/week for 8 weeks and restraint of the unaffected limb at home for 2 hrs per day ) or control group (conventional upper extremity rehabilitation training 1.5 hours per session, 3/week for 8 weeks and home exercise 2 hrs per day).

Body function and structures outcome measures, such as Fugl-Meyer Assessment, Actigraph ; activity and participation measures, such as Wolf Motor Function Test, Motor Activity Log, will be assessed before, after intervention, and 3 months post-intervention. Investigators will also monitor the kinematic data of InMotion 3.0 robot across the whole course of Robotic mCIMT to see how the Robotic mCIMT following BoNT-A injection impacts motor learning process of the participants.

Analysis: To evaluate the treatment effects of the outcome measures, 2 groups (Robotic mCIMT or control) * 3 times (before intervention, after intervention, and 3 months after intervention) repeated-measure ANOVA will be used.

Conditions

Stroke; Hemiplegia, Spastic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic mCIMT group

1 hour unilateral robotic therapy, followed by 30 minutes of functional practice of affected UE using shaping technique, 3/week for 8 weeks and restraint of the unaffected limb at home for 2 hrs per day

Group Type: EXPERIMENTAL

Robotic Constraint-induced movement therapy

Intervention Type: OTHER

i.Robotic repetitive task-specific training followed by task-oriented practice: during each session, participants first receive 60 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 30 minutes of functional practice using shaping technique.

ii.Restraint of the unaffected limb: Patients will wear a mitt to restrict the unaffected hand during training at clinic for 0.5 hours of functional practice each session, 3 sessions per week for 8 weeks.

iii. Transfer package: The transfer package aims at transferring the therapy gains to the participant's real world by use of a set of behavioral techniques. This is intended to have the participant responsible for adhering to the treatment requirements and encourage active engagement in the functional practice outside of the clinic setting. The participants will be given appropriated home assignment practicing daily activities outside of the clinic.

Control group

conventional upper extremity rehabilitation training 1.5 hours per session, 3/week for 8 weeks and home exercise 2 hrs per day

Group Type: ACTIVE_COMPARATOR

conventional UE rehabilitation training

Intervention Type: OTHER

focusing on UE training and including neuro-developmental techniques(Bobath, 1990), trunk-arm control (ie, practice UE tasks during standing), weight bearing by the affected arm, fine motor tasks practice, functional task practice, and practice on compensatory strategies for daily activities.

Interventions

Robotic Constraint-induced movement therapy

i.Robotic repetitive task-specific training followed by task-oriented practice: during each session, participants first receive 60 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 30 minutes of functional practice using shaping technique.

ii.Restraint of the unaffected limb: Patients will wear a mitt to restrict the unaffected hand during training at clinic for 0.5 hours of functional practice each session, 3 sessions per week for 8 weeks.

iii. Transfer package: The transfer package aims at transferring the therapy gains to the participant's real world by use of a set of behavioral techniques. This is intended to have the participant responsible for adhering to the treatment requirements and encourage active engagement in the functional practice outside of the clinic setting. The participants will be given appropriated home assignment practicing daily activities outside of the clinic.

Intervention Type: OTHER

conventional UE rehabilitation training

focusing on UE training and including neuro-developmental techniques(Bobath, 1990), trunk-arm control (ie, practice UE tasks during standing), weight bearing by the affected arm, fine motor tasks practice, functional task practice, and practice on compensatory strategies for daily activities.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• (1) clinical and imagine diagnosis of a first or recurrent unilateral stroke ≥ 3 months; (2) upper limb spasticity (modified Ashworth scale of ≥ 1+ for elbow flexor and/or forearm pronator and/or finger flexor muscles and/or wrist flexor muscles (Bohannon & Smith, 1987); (3) initial motor part of UE of FMA score ranging from 17 to 56, indicating moderate to severe movement impairment (Duncan, Goldstein, Matchar, Divine, & Feussner, 1992; Fugl Meyer, Jaasko, & Leyman, 1975; Park, Wolf, Blanton, Winstein, & Nichols-Larsen, 2008); (4) no serious cognitive impairment (i.e., Mini Mental State Exam score > 20) (Teng & Chui, 1987); (5) age ≥ 20 years ; and (6) willing to provide written informed consent.

Exclusion Criteria

• 1. pregnant 2. with bilateral hemispheric or cerebellar lesions 3. sever aphasia 4. significant visual field deficits or hemineglect 5. contraindication for BoNT-A injection 6. treatment with BoNT-A within 4 months before recruitment 7. any fixed joint contracture of the affected upper limb 8. a history of orthopedic or other neurological diseases and/or medical conditions that would prevent adherence to the rehabilitation protocol.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung University

OTHER

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jen-Wen Hung

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

CMRPG8H1261

Identifier Type: -

Identifier Source: org_study_id