Mirror Feedback, Augmented Task-Specific, Impairment-Oriented Therapy, Home Practice, Stroke Rehabilitation

NCT ID: NCT04978311

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-29
• Study Completion Date: 2022-07-31

Brief Summary

In this study, the investigators will (1) examine immediate and long-term effects of MT priming with task-specific training versus MT-priming with impairment-oriented training, relative to a dose-matched control therapy on motor function, arm activities, quality of life, etc; (2) provide comprehensive evaluations based on the ICF model to identify the specific benefits of MT-priming regimens; and (3) explore demographic and clinical characteristics of participants that may predict treatment outcomes.

Detailed Description

Stroke is one of the major causes of long-term disability. Most stroke survivors suffer from arm paresis even in the chronic phase. There is a need to develop novel strategies to augment therapeutic efficacy in stroke rehabilitation. One potential method to enhance treatment efficacy is through the "priming" technique. Among all priming techniques, mirror therapy (MT) has been proposed to be a promising method to augment effects of motor re-training. The investigators propose a 3-year research project to determine the effects of MT-priming on augmenting stroke interventions. The investigators select two types of evidence-based neurorehabilitation, the task-specific training and the impairment-oriented training, to be primed by MT based on their unique treatment benefits on restoring arm ability. In addition, the investigators will provide customized home practice corresponding to each type of interventions. Specifically, the investigators will (1) examine immediate and long-term effects of MT priming with task-specific training versus MT-priming with impairment-oriented training, relative to a dose-matched control therapy on motor function, arm activities, quality of life, etc; (2) provide comprehensive evaluations based on the ICF model to identify the specific benefits of MT-priming regimens; and (3) explore demographic and clinical characteristics of participants that may predict treatment outcomes.

Conditions

Stroke Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mirror therapy (MT) priming with task-specific training

In the regimen, participants will perform MT first followed by task-specific training. After completion of MT, participants will practice task-specific training that emphasizes on restoration of essential skills for daily activities. After that, the contents of home practice will be designed corresponding to treatment principles of the clinic-based intervention.

Group Type: EXPERIMENTAL

Mirror therapy (MT) priming with task-specific training

Intervention Type: BEHAVIORAL

In the regimen, participants will perform MT first followed by task-specific training. After completion of MT, participants will practice task-specific training that emphasizes on restoration of essential skills for daily activities. After that, the contents of home practice will be designed corresponding to treatment principles of the clinic-based intervention.

Mirror therapy priming with impairment-oriented training

In the regimen, participants will perform MT first followed by impairment-oriented training. After completion of MT, participants will practice impairment-oriented training that emphasizes on restoration of movement. After that, the contents of home practice will be designed corresponding to treatment principles of the clinic-based intervention.

Group Type: ACTIVE_COMPARATOR

Mirror therapy priming with impairment-oriented training

Intervention Type: BEHAVIORAL

In the regimen, participants will perform MT first followed by impairment-oriented training. After completion of MT, participants will practice impairment-oriented training that emphasizes on restoration of movement. After that, the contents of home practice will be designed corresponding to treatment principles of the clinic-based intervention.

Control therapy

The control group will receive therapeutic training equivalent in duration to the two experimental groups. The control intervention will include practice of gross/fine motor activities, training of activities of daily living, practice to increase range of motions, muscle strengthening, as well as use of adaptive or compensatory technique to alleviate functional deficits. After that, the contents of home practice will be designed corresponding to treatment principles of the clinic-based intervention.

Group Type: ACTIVE_COMPARATOR

Control therapy

Intervention Type: BEHAVIORAL

The control group will receive therapeutic training equivalent in duration to the two experimental groups. The control intervention will include practice of gross/fine motor activities, training of activities of daily living, practice to increase range of motions, muscle strengthening, as well as use of adaptive or compensatory technique to alleviate functional deficits. After that, the contents of home practice will be designed corresponding to treatment principles of the clinic-based intervention.

Interventions

Mirror therapy (MT) priming with task-specific training

In the regimen, participants will perform MT first followed by task-specific training. After completion of MT, participants will practice task-specific training that emphasizes on restoration of essential skills for daily activities. After that, the contents of home practice will be designed corresponding to treatment principles of the clinic-based intervention.

Intervention Type: BEHAVIORAL

Mirror therapy priming with impairment-oriented training

In the regimen, participants will perform MT first followed by impairment-oriented training. After completion of MT, participants will practice impairment-oriented training that emphasizes on restoration of movement. After that, the contents of home practice will be designed corresponding to treatment principles of the clinic-based intervention.

Intervention Type: BEHAVIORAL

Control therapy

The control group will receive therapeutic training equivalent in duration to the two experimental groups. The control intervention will include practice of gross/fine motor activities, training of activities of daily living, practice to increase range of motions, muscle strengthening, as well as use of adaptive or compensatory technique to alleviate functional deficits. After that, the contents of home practice will be designed corresponding to treatment principles of the clinic-based intervention.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• A first ever-stroke≧3 months
• Baseline Fugl-Meyer assessment of upper extremity scale (FMA-UE) between 18 to 56 (Fugl-Meyer et al. 1975)
• No excessive muscle spasticity of the affected arm (Modified Ashworth Scale < 3 at any joints of the affected arm) (Bohannon & Smith 1987)
• Able to follow examiners' commands and study instructions (Mini-Mental State Examination score≧22) (Folstein et al. 1975)
• No participation in any other experimental rehabilitation or drug studies during period of this project

Exclusion Criteria

• Concomitant neurologic, neuromuscular or orthopedic conditions that may interfere with participation of this project
• Epilepsy within three months

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keh-chung Lin, ScD

Role: PRINCIPAL_INVESTIGATOR

School of Occupational Therapy, National Taiwan University, Taipei, Taiwan

Locations

Feng Yuan Hospital

Taichung, , Taiwan

National Taiwan University Hosipital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201812032RINA

Identifier Type: -

Identifier Source: org_study_id