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

NCT04978311 | Completed

• 1 other identifier: 201812032RINA
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks, and 18 weeks

  The upper-extremity subscale of the FMA will be used to assess motor impairment. FMA contains 33 items (scale 0-66). The higher summed score means the greater recovery of motor impairment.

  Baseline, 6 weeks, and 18 weeks

• Change from Baseline Motor Activity Log (MAL) at 6 weeks, and 18 weeks

  The MAL is a subjective outcome measure of an individual's real life functional upper limb performance. The MAL is administered by semi-structured interview to determine (a) how much (Amount of Use - AOU), and (b) how well the individual uses his upper limb (Quality of Movement - QOM) in real life.

  Baseline, 6 weeks and 18 weeks

Secondary Outcomes (5)

• Change from Baseline Nottingham Extended Activities of Daily Living Scale (NEADL) at 6 weeks, and 18 weeks

  Baseline, 6 weeks and 18 weeks

• Change from Baseline Stroke Impact Scale Version 3.0 (SIS 3.0) at 6 weeks, and 18 weeks

  Baseline, 6 weeks, and 18 weeks

• Change from Baseline Wolf Motor Function Test (WMFT) score at 6 weeks

  Baseline and 6 weeks

• Change from Baseline Grip and Pinch strength at 6 weeks

  Baseline and 6 weeks

• Change from Baseline Chedoke Arm and Hand Activity Inventory (CAHAI) at 6 weeks

  Baseline and 6 weeks

Study Arms (3)

Mirror therapy (MT) priming with task-specific training

EXPERIMENTAL

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.

Behavioral: Mirror therapy (MT) priming with task-specific training

Mirror therapy priming with impairment-oriented training

ACTIVE COMPARATOR

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.

Behavioral: Mirror therapy priming with impairment-oriented training

Control therapy

ACTIVE COMPARATOR

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.

Behavioral: Control therapy

Interventions

Mirror therapy (MT) priming with task-specific training 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 (MT) priming with task-specific training

Mirror therapy priming with impairment-oriented training 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.

Mirror therapy priming with impairment-oriented training

Control therapy 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.

Control therapy

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

Feng Yuan Hospital

Taichung, Taiwan

Location

National Taiwan University Hosipital

Taipei, 100, Taiwan

Location

MeSH Terms

Interventions

Mirror Movement Therapy

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Keh-chung Lin, ScD

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

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: July 27, 2021
• Study Start: July 29, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: June 25, 2024

Record last verified: 2022-08

Locations

TW (2)