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

Primary Purpose

Stroke Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Mirror therapy (MT) priming with task-specific training
Mirror therapy priming with impairment-oriented training
Control therapy
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Rehabilitation

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Feng Yuan Hospital
  • National Taiwan University Hosipital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Mirror therapy (MT) priming with task-specific training

Mirror therapy priming with impairment-oriented training

Control therapy

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change from Baseline Nottingham Extended Activities of Daily Living Scale (NEADL) at 6 weeks, and 18 weeks
The NEADL is a postal questionnaire to monitor the level of ADL disability in patients discharged into the community after rehabilitation. The tool assesses 21 activities within four categories: mobility, kitchen activities, domestic activities, and leisure activities. It provides an extended ADL score that is highly correlated with more complex, self-reported interviewer-administered measures of disability.
Change from Baseline Stroke Impact Scale Version 3.0 (SIS 3.0) at 6 weeks, and 18 weeks
The SIS 3.0 is a stroke-specific health-related quality of life instrument. It consists of 59 items assessing 8 domains (i.e., strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion. memory and thinking and participation). Items are rated on a 5-point Likert scale, with lower scores indicating greater difficulty in task completion during the past week.
Change from Baseline Wolf Motor Function Test (WMFT) score at 6 weeks
The WMFT quantifies the motor functions of the upper limbs through timed and functional tasks.
Change from Baseline Grip strength at 6 weeks
The Jamar Plus Digital Hand Dynamometer (Patterson Medical, Warrenville, IL, USA) was provided for measuring grip strength. Unilateral grip and bilateral grip are included.
Change from Baseline Chedoke Arm and Hand Activity Inventory (CAHAI) at 6 weeks
The CAHAI measures arm and hand functions on 13 actual bilateral tasks on a 7-point scale (1 to 7). The properties of the CAHAI were studied, showing great interrater reliability and convergent and discriminant cross-sectional validity.

Full Information

First Posted
July 18, 2021
Last Updated
August 11, 2022
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04978311
Brief Title
Mirror Feedback, Augmented Task-Specific, Impairment-Oriented Therapy, Home Practice, Stroke Rehabilitation
Official Title
The Effects of Mirror Feedback Augmented Task-Specific and Impairment-Oriented Therapy With Home Practice in Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 29, 2020 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirror therapy (MT) priming with task-specific training
Arm Type
Experimental
Arm Description
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.
Arm Title
Mirror therapy priming with impairment-oriented training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control therapy
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Mirror therapy (MT) priming with task-specific training
Intervention Description
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
Intervention Name(s)
Mirror therapy priming with impairment-oriented training
Intervention Description
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
Intervention Name(s)
Control therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks, and 18 weeks
Description
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.
Time Frame
Baseline, 6 weeks, and 18 weeks
Title
Change from Baseline Motor Activity Log (MAL) at 6 weeks, and 18 weeks
Description
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.
Time Frame
Baseline, 6 weeks and 18 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline Nottingham Extended Activities of Daily Living Scale (NEADL) at 6 weeks, and 18 weeks
Description
The NEADL is a postal questionnaire to monitor the level of ADL disability in patients discharged into the community after rehabilitation. The tool assesses 21 activities within four categories: mobility, kitchen activities, domestic activities, and leisure activities. It provides an extended ADL score that is highly correlated with more complex, self-reported interviewer-administered measures of disability.
Time Frame
Baseline, 6 weeks and 18 weeks
Title
Change from Baseline Stroke Impact Scale Version 3.0 (SIS 3.0) at 6 weeks, and 18 weeks
Description
The SIS 3.0 is a stroke-specific health-related quality of life instrument. It consists of 59 items assessing 8 domains (i.e., strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion. memory and thinking and participation). Items are rated on a 5-point Likert scale, with lower scores indicating greater difficulty in task completion during the past week.
Time Frame
Baseline, 6 weeks, and 18 weeks
Title
Change from Baseline Wolf Motor Function Test (WMFT) score at 6 weeks
Description
The WMFT quantifies the motor functions of the upper limbs through timed and functional tasks.
Time Frame
Baseline and 6 weeks
Title
Change from Baseline Grip strength at 6 weeks
Description
The Jamar Plus Digital Hand Dynamometer (Patterson Medical, Warrenville, IL, USA) was provided for measuring grip strength. Unilateral grip and bilateral grip are included.
Time Frame
Baseline and 6 weeks
Title
Change from Baseline Chedoke Arm and Hand Activity Inventory (CAHAI) at 6 weeks
Description
The CAHAI measures arm and hand functions on 13 actual bilateral tasks on a 7-point scale (1 to 7). The properties of the CAHAI were studied, showing great interrater reliability and convergent and discriminant cross-sectional validity.
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keh-chung Lin, ScD
Organizational Affiliation
School of Occupational Therapy, National Taiwan University, Taipei, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Feng Yuan Hospital
City
Taichung
Country
Taiwan
Facility Name
National Taiwan University Hosipital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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

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