Stroke RehabilitationNCT04978311
Mirror Feedback, Augmented Task-Specific, Impairment-Oriented Therapy, Home Practice, Stroke Rehabilitation
A study testing Mirror therapy (MT) priming with task-specific training and Mirror therapy priming with impairment-oriented training in people with Stroke Rehabilitation, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Stroke Rehabilitation
- What is being tested?
- Mirror therapy (MT) priming with task-specific training and Mirror therapy priming with impairment-oriented training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesTaiwan
- Study dates
- 29 Jul 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Concomitant neurologic, neuromuscular or orthopedic conditions that may interfere with participation of this project
- Epilepsy within three months
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Feng Yuan Hospital
Taichung
National Taiwan University Hosipital
Taipei, 100
About this study
Official title: The Effects of Mirror Feedback Augmented Task-Specific and Impairment-Oriented Therapy With Home Practice in Stroke Rehabilitation
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.
Read the 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
- Being tested
- Mirror therapy (MT) priming with task-specific training, Mirror therapy priming with impairment-oriented training, Control therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror therapy (MT) priming with task-specific trainingBehavioural
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 trainingBehavioural
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 therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Control therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: Baseline, 6 weeks and 18 weeks
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.
Measured: Baseline, 6 weeks, and 18 weeks
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.
Measured: Baseline and 6 weeks
Change from Baseline Grip and Pinch strength at 6 weeks
The Jamar Plus Digital Hand Dynamometer (Patterson Medical, Warrenville, IL, USA) was provided for measuring grip and pinch strength. Unilateral grip/pinch and bilateral grip/pinch are included.
Measured: Baseline and 6 weeks
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.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start29 Jul 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke RehabilitationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keh-chung Lin, ScD, Principal investigator, School of Occupational Therapy, National Taiwan University, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978311
- Sponsor's protocol ID
- 201812032RINA
- Status last verified
- Aug 2022
- First submitted
- 18 Jul 2021
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu SY, Li YC, Chen YW, Chen CL, Pan HC, Lin KC, Lau HY. Construct validity, responsiveness, minimal detectable change, and minimal clinically important difference of the stroke self-efficacy questionnaire in individuals receiving stroke rehabilitation. Disabil Rehabil. 2024 Dec;46(25):6195-6203. doi: 10.1080/09638288.2024.2324122. Epub 2024 Mar 3.
PubMed 38433459
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mirror Feedback Augmented Task-Specific and Impairment-Oriented Therapy With Home Practice in Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT04978311
- Acronym / sponsor ID
- 201812032RINA
- Conditions
- Stroke Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mirror therapy (MT) priming with task-specific training | Experimental | Behavioral: Mirror therapy (MT) priming with task-specific trainingIn 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 | Active comparator | Behavioral: Mirror therapy priming with impairment-oriented trainingIn 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 | Active comparator | Behavioral: Control therapyThe 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Concomitant neurologic, neuromuscular or orthopedic conditions that may interfere with participation of this project
- Epilepsy within three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirror therapy (MT) priming with task-specific trainingIn 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. | Behavioural | Mirror therapy (MT) priming with task-specific training |
| Mirror therapy priming with impairment-oriented trainingIn 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. | Behavioural | Mirror therapy priming with impairment-oriented training |
| Control therapyThe 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. | Behavioural | Control therapy |
Primary outcome
Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks, and 18 weeks
Time frame: Baseline, 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
Time frame: Baseline, 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.
5 secondary outcomes
Change from Baseline Nottingham Extended Activities of Daily Living Scale (NEADL) at 6 weeks, and 18 weeks
Time frame: Baseline, 6 weeks and 18 weeks
Change from Baseline Stroke Impact Scale Version 3.0 (SIS 3.0) at 6 weeks, and 18 weeks
Time frame: Baseline, 6 weeks, and 18 weeks
Change from Baseline Wolf Motor Function Test (WMFT) score at 6 weeks
Time frame: Baseline and 6 weeks
Change from Baseline Grip and Pinch strength at 6 weeks
Time frame: Baseline and 6 weeks
Change from Baseline Chedoke Arm and Hand Activity Inventory (CAHAI) at 6 weeks
Time frame: Baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Derived from this study: PubMed 38433459Wu SY, Li YC, Chen YW, Chen CL, Pan HC, Lin KC, Lau HY. Construct validity, responsiveness, minimal detectable change, and minimal clinically important difference of the stroke self-efficacy questionnaire in individuals receiving stroke rehabilitation. Disabil Rehabil. 2024 Dec;46(25):6195-6203. doi: 10.1080/09638288.2024.2324122. Epub 2024 Mar 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keh-chung Lin, ScD principal investigator
School of Occupational Therapy, National Taiwan University, Taipei, Taiwan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror therapy (MT) priming with task-specific training and Mirror therapy priming with impairment-oriented training in people with Stroke Rehabilitation, run by National Taiwan University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks, and 18 weeks (time frame: Baseline, 6 weeks, and 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04978311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.