Stroke RehabilitationNCT05467813
Mirror Therapy Preceding Augmented Reality in Stroke Rehabilitation
A study testing mirror therapy and augmented reality (AR) in people with Stroke Rehabilitation, run by National Taiwan University Hospital at 5 sites in Taiwan.
Trial summary
This proposed research is in line with the National Health Research Institutes (NHRI) Innovative Research Grant priority to address innovative treatment strategies for neurological disorders that are in desperate need of scientific scrutiny. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke Rehabilitation
- What is being tested?
- mirror therapy and augmented reality (AR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesTaiwan
- Study dates
- 23 Jul 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a first-ever unilateral stroke ≥3 months
- age between 20 and 80 years
- baseline FMA-UE >10
- no severe spasticity in any joints of the affected arm MAS < 3)
- ability to follow the instructions of the evaluator and therapists (Mini-Mental State Examination Score ≥22)
- ability to stand in a step-standing position for at least 30 seconds
Show all 10Show fewer
- ability to walk a minimum of 10 meters with or without a device
- no severe vision impairments and other major neurologic diseases
- ability to take part in a rehabilitation intervention program for 9 weeks
- not participating in other studies over the study period and willingness to provide informed written consent.
Who cannot join
- acute inflammation
- serious medical problems or poor physical conditions that might be detrimental to study participation
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Taiwan5 sites, 5 recruiting
- Recruiting
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation
New Taipei City
Keh-Chung Lin, ScD
- Recruiting
Feng Yuan Hospital, Ministry of Health and Welfare
Taichung
Keh-Chung Lin, ScD
- Recruiting
National Taiwan University Hospital
Taipei
Keh-chung Lin, Sc.D, +886 33668180, kehchunglin@ntu.edu.tw
- Recruiting
Taipei Hospital, Ministry of Health and Welfare
Taipei
Keh-Chung Lin, ScD
- Recruiting
Linkou Chang Gung Memorial Hospital, Chang Gung Medical Foundation
Taoyuan
Keh-Chung Lin, ScD
About this study
Official title: Mirror Therapy Preceding Augmented Reality in Stroke Rehabilitation: A Cross-Setting Study
This proposed research is in line with the National Health Research Institutes (NHRI) Innovative Research Grant priority to address innovative treatment strategies for neurological disorders that are in desperate need of scientific scrutiny. Stroke is one of the major medical conditions that leads to long-term disability and causes a heavy health care and financial burden. To meet multiple needs of patients with stroke, hybrid interventions that combine different approaches and practices in different settings are needed based on the complexity of stroke. Our previous research funded by the NHRI has been published and translated to stroke rehabilitation. Extending our previous research, the investigators will study the benefits of novel rehabilitation regimens of mirror therapy preceding augmented reality as well as the effects of practice setting (i.e., clinic- vs. home-based settings). In line with the current trend for the development of mirror therapy, mirror therapy will be implemented based on the bilateral and unilateral approach. Augmented reality will be implemented as a means of exergaming with real-time feedback to motivate the patients with stroke for active participation. In addition, telehealth techniques will be used to monitor home practice. This research is innovative in the use of telehealth techniques that will meet the call for therapy outside of the clinical settings in the era of COVID-19 pandemic.
Read the detailed description
This proposed research is in line with the National Health Research Institutes (NHRI) Innovative Research Grant priority to address innovative treatment strategies for neurological disorders that are in desperate need of scientific scrutiny. Stroke is one of the major medical conditions that leads to long-term disability and causes a heavy health care and financial burden. To meet multiple needs of patients with stroke, hybrid interventions that combine different approaches and practices in different settings are needed based on the complexity of stroke. Our previous research funded by the NHRI has been published and translated to stroke rehabilitation. Extending our previous research, the investigators will study the benefits of novel rehabilitation regimens of mirror therapy preceding augmented reality as well as the effects of practice setting (i.e., clinic- vs. home-based settings). In line with the current trend for the development of mirror therapy, mirror therapy will be implemented based on the bilateral and unilateral approach. Augmented reality will be implemented as a means of exergaming with real-time feedback to motivate the patients with stroke for active participation. In addition, telehealth techniques will be used to monitor home practice. This research is innovative in the use of telehealth techniques that will meet the call for therapy outside of the clinical settings in the era of COVID-19 pandemic.
Current stroke rehabilitation programs, such as mirror therapy and augmented reality and their combination, are novel intervention approaches that have promise for feedback-enhanced stroke rehabilitation. Mirror therapy may contribute to bilateral brain coupling by means of mirror visual feedback. It can potentially be an effective priming technique for creating an enriched neuroplastic environment to facilitate motor and functional recovery. Augmented reality is powered by its potential to provide an intensive, repetitive, and context-rich training program and promote motor, mobility, and cognition function recovery. Mirror therapy and augmented reality can be complementary for formulating a hybrid regimen. Mirror therapy has been implemented conventionally by being based on a bilateral approach. Our innovative protocol will include both unilateral mirror therapy and bilateral mirror therapy using personally relevant task objects for improving task performance. In addition, the investigators will extend clinic-based practice to practice in the home environment by using telehealth techniques for monitoring performance and providing feedback. The goals of this proposed research project will be to examine the effects of the hybrid intervention of mirror therapy preceding augmented reality or conventional therapy on sensory and motor function, mobility, daily function, life quality, and self-efficacy in stroke patients; compare the effects of the hybrid regimen in the clinical versus the home setting; and identify the potential predictors of treatment success using machine learning techniques.
- Conditions
- Stroke Rehabilitation
- Being tested
- mirror therapy, augmented reality (AR), control therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirror therapyOther
The mirror therapy (MT) will be done with participants seated at a table. The affected upper-extremity (UE) will be placed behind the mirror and the unaffected UE in front of the mirror. Participants will be asked to do the same movements using both the unaffected and affected UE as possible. Each participant will practice two different MT protocols: unilateral mirror therapy (UMT) and bilateral mirror therapy (BMT). During UMT, the affected hand is static, while during BMT, the affected hand moves in an attempt to duplicate the unaffected hand as best as possible. The MT activities include gross motor movements, fine motor movements, and object manipulation.
augmented reality (AR)Other
The training program provides goal-directed exercises designed to be adjustable in order to match the patient's ability to minimize compensatory movements. To ensure safety, the investigators will place a handrail in front of the participant for support. The goal-directed exercise includes balance training (i.e., weight shifting, standing on one leg), activities of daily living training (i.e., reaching), and cognitive enhancement (i.e., memory training). By using the AR system, participants can observe the real performance of motions and interaction between the body and the virtual environment.
control therapyOther
The control intervention will include practice of upper limb activities, balance activities, activities of daily living, and cognitive enhancement tasks. The protocols of the conventional therapy will be formulated by using occupational therapy techniques, such as neurodevelopmental techniques and functional task training. The therapy will be adapted to the participants' levels of motor deficits and their prioritized goals. The protocol will include affected arm exercise or gross motor training, muscle strengthening of the affected arm, fine motor or dexterity training, and functional tasks of daily life or compensatory techniques to alleviate functional deficits. The therapist will work with the participant to select functionally relevant tasks, such as picking up items from a box, lifting soft drink bottles, hanging clothes, and so on.
| Study group | Role | What they receive |
|---|---|---|
| clinic-setting MT preceding AR-first group | Experimental | In the experimental group, the participants will receive clinic-based rehabilitation first. After a 3-week washout period, the participants will receive home-based rehabilitation. Receives: Other: mirror therapy; Other: augmented reality (AR) |
| home-based MT preceding AR-first group | Active comparator | The comparison group will receive home-based rehabilitation first. After a 3-week washout period, the participants will receive clinic-based rehabilitation. Receives: Other: mirror therapy; Other: augmented reality (AR) |
| conventional therapy in the clinical setting | Active comparator | The control group will receive clinic-based rehabilitation, followed by clinic-based rehabilitative interventions. The participants will practice home-based program on a regular basis. Receives: Other: 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 3 weeks, 6 weeks, 9 weeks, and 21 weeks.
The upper-extremity subscale of the FMA will be used for the assessment of motor impairment. Movements and reflexes of the shoulder/elbow/forearm, wrist, hand, and coordination/speed are scored. Each score is on an ordinal scale of 3 points (0 = cannot perform, 1 = performs partially, 2 = performs fully). The highest score is 66, which indicates optimum recovery. The subscale score of a proximal shoulder/elbow (FMA s/e: 0-42) and a distal hand/wrist (FMA h/w: 0-24) will be calculated to study the effects of treatment on separate elements of the upper extremities. The FMA has good reliability, validity, and responsiveness in stroke.
Measured: Baseline, 3 weeks, 6 weeks, 9 weeks, and 21 weeks
Change from Baseline Berg Balance Scale (BBS) at 3 weeks, 6 weeks, 9 weeks, and 21 weeks.
The BBS is identified as one of the most widely used evaluation tools of balance across the continuum from acute clinic-based to community-based care. There are 14 items assessing the patient's ability to maintain balance, either statically or with a variety of functional movements, over a given time period. Each score is on a 5-point ordinal scale (0 = inability to complete the task, 4 = independent item completion). The maximum score is 56, representing good balance. The BBS is a reliable and valid tool in assessing balance and functional mobility for stroke.
Measured: Baseline, 3 weeks, 6 weeks, 9 weeks, and 21 weeks
Secondary outcomes (8)
Revised Nottingham Sensory Assessment (rNSA)
The rNSA will be used to assess changes of sensation. Various sensory assessments will be used to evaluate the tactile sensation, proprioception, and stereognosis of the various body segments. The rNSA rating is based on an ordinal scale of 3 points (0-2), with a lower score indicating more sensory impairment. Its psychometric properties have been determined for stroke.
Measured: 1,3,6,9,21 weeks
Chedoke Arm and Hand Activity Inventory (CAHAI)
The CAHAI evaluates the functional ability of the affected arm and hand to perform tasks after stroke. The 13 items contained in the CAHAI represent bimanual meaningful everyday activities and are made up a variety of the upper-extremity characteristics, including strength, dexterity, coordination, and grasp. The 7-point activity scale is used in the CAHAI, where 1 indicates "performing less than 25% of the effort to complete the task" and 7 indicates "the participants' affected upper extremity is able to complete the task competently independently." The reliability and validity of the CAHAI have been ascertained in stroke.
Measured: 1,3,6,9,21 weeks
Motor Activity Log (MAL)
The MAL is a self-reported semistructured interview that rates the frequency of use (MAL-amount of use [AOU]) and quality (MAL-quality of movement [QOM]) of the affected upper extremity. It consists of 30 functional tasks in real life, such as turning on a light with a light switch, opening a refrigerator, or washing hands. The scale ranges from 0 to 5 (0 = did not use the affected arm, 1 = occasionally used the affected arm but only very rarely/the affected arm was moved during that activity but was not helpful, 5 = used the affected arm as often as before the stroke/the ability to use the affected arm for that activity was as good as before the stroke). Its reliability and validity have been confirmed in stroke.
Measured: 1,3,6,9,21 weeks
modified Rankin scale
The individual with a stroke can use the modified Rankin Scale (MRS) as a single-item global outcomes rating scale to categorize functional independence based on pre-stroke activities.
Measured: 1,3,6,9,21 weeks
Stroke Impact Scale Version 3.0 (SIS 3.0)
The SIS 3.0 measures stroke-specific health-related quality of life. It includes 59 items assessing eight domains (i.e., strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion. memory and thinking and participation), with a single item evaluating the overall perceived recovery of the stroke. Items are graded on a 5-point Likert scale, with lower scores indicating higher difficulty in completing the tasks over the past week. The SIS 3.0 has satisfactory reliability, validity, and responsiveness in patients after stroke.
Measured: 1,3,6,9,21 weeks
Stroke-Specific Measure of Adherence to Home-based Exercises (SS-MAHE)
The investigators include this test because adherence to home-setting interventions is essential for achieving meaningful changes in the treatment outcomes. The SS-MAHE is a validated stroke-specific questionnaire assessing adherence to home-setting practice among stroke patients. It consists of two sections: (a) the dosage of prescribed practice activities and (b) dosage of actual practice activities done by the participants. The repetition, frequency, and the duration for each activity will be recorded, and the intensity will be indicated using the visual analog scale. The overall SS-MAHE score will be calculated by the following formula:
Level of adherence = (Total of percentage adherence to prescribed parameters)/(Number of prescribed parameters) × 100
Measured: 1,3,6,9,21 weeks
Possible Adverse Response
The self-reported assessments complemented by the vertical numerical faces rating scale will be delivered for the assessment adverse effects on fatigue and pain severity. The two assessments using 11-point scale (0 = no fatigue/pain to 10 = worst possible fatigue/pain) will be done at the end of each intervention session and at 3 months in the follow-up period. The therapist can tailor the practice activities in accordance with the perceived burdens of the participant. The reliability and validity of these two measurements of fatigue/pain intensity in patients with stroke are supported by previous study.
Measured: through study completion, an average of 21 weeks
Montreal Cognitive Assessment
The Montreal Cognitive Assessment is a cognitive screening assessment that is used to measure several cognitive domains, which include working memory, delayed recall, visuospatial abilities, executive functions, attention, concentration, language, and orientation to time and place. The total score ranges from 0 to 30. One extra point is added to adjust the total score for participants who received less than 12 years of education.
Measured: 1 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 posted21 Jul 2022
- Study start23 Jul 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keh-Chung Lin, Sc.D, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467813
- Sponsor's protocol ID
- 202201072RINA
- Status last verified
- Feb 2025
- First submitted
- 3 Jul 2022
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirror Therapy Preceding Augmented Reality in Stroke Rehabilitation: A Cross-Setting Study
- ClinicalTrials.gov ID
- NCT05467813
- Acronym / sponsor ID
- 202201072RINA
- Conditions
- Stroke Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 23 Jul 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Jul 2022 (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.
This proposed research is in line with the National Health Research Institutes (NHRI) Innovative Research Grant priority to address innovative treatment strategies for neurological disorders that are in desperate need of scientific scrutiny. Stroke is one of the major medical conditions that leads to long-term disability and causes a heavy health care and financial burden. To meet multiple needs of patients with stroke, hybrid interventions that combine different approaches and practices in different settings are needed based on the complexity of stroke. Our previous research funded by the NHRI has been published and translated to stroke rehabilitation. Extending our previous research, the investigators will study the benefits of novel rehabilitation regimens of mirror therapy preceding augmented reality as well as the effects of practice setting (i.e., clinic- vs. home-based settings). In line with the current trend for the development of mirror therapy, mirror therapy will be implemented based on the bilateral and unilateral approach. Augmented reality will be implemented as a means of exergaming with real-time feedback to motivate the patients with stroke for active participation. In addition, telehealth techniques will be used to monitor home practice. This research is innovative in the use of telehealth techniques that will meet the call for therapy outside of the clinical settings in the era of COVID-19 pandemic.
Detailed description
This proposed research is in line with the National Health Research Institutes (NHRI) Innovative Research Grant priority to address innovative treatment strategies for neurological disorders that are in desperate need of scientific scrutiny. Stroke is one of the major medical conditions that leads to long-term disability and causes a heavy health care and financial burden. To meet multiple needs of patients with stroke, hybrid interventions that combine different approaches and practices in different settings are needed based on the complexity of stroke. Our previous research funded by the NHRI has been published and translated to stroke rehabilitation. Extending our previous research, the investigators will study the benefits of novel rehabilitation regimens of mirror therapy preceding augmented reality as well as the effects of practice setting (i.e., clinic- vs. home-based settings). In line with the current trend for the development of mirror therapy, mirror therapy will be implemented based on the bilateral and unilateral approach. Augmented reality will be implemented as a means of exergaming with real-time feedback to motivate the patients with stroke for active participation. In addition, telehealth techniques will be used to monitor home practice. This research is innovative in the use of telehealth techniques that will meet the call for therapy outside of the clinical settings in the era of COVID-19 pandemic.
Current stroke rehabilitation programs, such as mirror therapy and augmented reality and their combination, are novel intervention approaches that have promise for feedback-enhanced stroke rehabilitation. Mirror therapy may contribute to bilateral brain coupling by means of mirror visual feedback. It can potentially be an effective priming technique for creating an enriched neuroplastic environment to facilitate motor and functional recovery. Augmented reality is powered by its potential to provide an intensive, repetitive, and context-rich training program and promote motor, mobility, and cognition function recovery. Mirror therapy and augmented reality can be complementary for formulating a hybrid regimen. Mirror therapy has been implemented conventionally by being based on a bilateral approach. Our innovative protocol will include both unilateral mirror therapy and bilateral mirror therapy using personally relevant task objects for improving task performance. In addition, the investigators will extend clinic-based practice to practice in the home environment by using telehealth techniques for monitoring performance and providing feedback. The goals of this proposed research project will be to examine the effects of the hybrid intervention of mirror therapy preceding augmented reality or conventional therapy on sensory and motor function, mobility, daily function, life quality, and self-efficacy in stroke patients; compare the effects of the hybrid regimen in the clinical versus the home setting; and identify the potential predictors of treatment success using machine learning techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| clinic-setting MT preceding AR-first group | Experimental | Other: mirror therapy, Other: augmented reality (AR)In the experimental group, the participants will receive clinic-based rehabilitation first. After a 3-week washout period, the participants will receive home-based rehabilitation. |
| home-based MT preceding AR-first group | Active comparator | Other: mirror therapy, Other: augmented reality (AR)The comparison group will receive home-based rehabilitation first. After a 3-week washout period, the participants will receive clinic-based rehabilitation. |
| conventional therapy in the clinical setting | Active comparator | Other: control therapyThe control group will receive clinic-based rehabilitation, followed by clinic-based rehabilitative interventions. The participants will practice home-based program on a regular basis. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- a first-ever unilateral stroke ≥3 months
- age between 20 and 80 years
- baseline FMA-UE >10
- no severe spasticity in any joints of the affected arm MAS < 3)
- ability to follow the instructions of the evaluator and therapists (Mini-Mental State Examination Score ≥22)
Key exclusion criteria (2 listed)
- acute inflammation
- serious medical problems or poor physical conditions that might be detrimental to study participation
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 therapyThe mirror therapy (MT) will be done with participants seated at a table. The affected upper-extremity (UE) will be placed behind the mirror and the unaffected UE in front of the mirror. Participants will be asked to do the same movements using both the unaffected and affected UE as possible. Each participant will practice two different MT protocols: unilateral mirror therapy (UMT) and bilateral mirror therapy (BMT). During UMT, the affected hand is static, while during BMT, the affected hand moves in an attempt to duplicate the unaffected hand as best as possible. The MT activities include gross motor movements, fine motor movements, and object manipulation. | Other | clinic-setting MT preceding AR-first group, home-based MT preceding AR-first group |
| augmented reality (AR)The training program provides goal-directed exercises designed to be adjustable in order to match the patient's ability to minimize compensatory movements. To ensure safety, the investigators will place a handrail in front of the participant for support. The goal-directed exercise includes balance training (i.e., weight shifting, standing on one leg), activities of daily living training (i.e., reaching), and cognitive enhancement (i.e., memory training). By using the AR system, participants can observe the real performance of motions and interaction between the body and the virtual environment. | Other | clinic-setting MT preceding AR-first group, home-based MT preceding AR-first group |
| control therapyThe control intervention will include practice of upper limb activities, balance activities, activities of daily living, and cognitive enhancement tasks. The protocols of the conventional therapy will be formulated by using occupational therapy techniques, such as neurodevelopmental techniques and functional task training. The therapy will be adapted to the participants' levels of motor deficits and their prioritized goals. The protocol will include affected arm exercise or gross motor training, muscle strengthening of the affected arm, fine motor or dexterity training, and functional tasks of daily life or compensatory techniques to alleviate functional deficits. The therapist will work with the participant to select functionally relevant tasks, such as picking up items from a box, lifting soft drink bottles, hanging clothes, and so on. | Other | conventional therapy in the clinical setting |
Primary outcome
Change from Baseline Fugl-Meyer Assessment (FMA) at 3 weeks, 6 weeks, 9 weeks, and 21 weeks.
Time frame: Baseline, 3 weeks, 6 weeks, 9 weeks, and 21 weeks
The upper-extremity subscale of the FMA will be used for the assessment of motor impairment. Movements and reflexes of the shoulder/elbow/forearm, wrist, hand, and coordination/speed are scored. Each score is on an ordinal scale of 3 points (0 = cannot perform, 1 = performs partially, 2 = performs fully). The highest score is 66, which indicates optimum recovery. The subscale score of a proximal shoulder/elbow (FMA s/e: 0-42) and a distal hand/wrist (FMA h/w: 0-24) will be calculated to study the effects of treatment on separate elements of the upper extremities. The FMA has good reliability, validity, and responsiveness in stroke.
Change from Baseline Berg Balance Scale (BBS) at 3 weeks, 6 weeks, 9 weeks, and 21 weeks.
Time frame: Baseline, 3 weeks, 6 weeks, 9 weeks, and 21 weeks
The BBS is identified as one of the most widely used evaluation tools of balance across the continuum from acute clinic-based to community-based care. There are 14 items assessing the patient's ability to maintain balance, either statically or with a variety of functional movements, over a given time period. Each score is on a 5-point ordinal scale (0 = inability to complete the task, 4 = independent item completion). The maximum score is 56, representing good balance. The BBS is a reliable and valid tool in assessing balance and functional mobility for stroke.
8 secondary outcomes
Revised Nottingham Sensory Assessment (rNSA)
Time frame: 1,3,6,9,21 weeks
Chedoke Arm and Hand Activity Inventory (CAHAI)
Time frame: 1,3,6,9,21 weeks
Motor Activity Log (MAL)
Time frame: 1,3,6,9,21 weeks
modified Rankin scale
Time frame: 1,3,6,9,21 weeks
Stroke Impact Scale Version 3.0 (SIS 3.0)
Time frame: 1,3,6,9,21 weeks
Stroke-Specific Measure of Adherence to Home-based Exercises (SS-MAHE)
Time frame: 1,3,6,9,21 weeks
Possible Adverse Response
Time frame: through study completion, an average of 21 weeks
Montreal Cognitive Assessment
Time frame: 1 and 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- 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.
- Individual participant dataSharing planned: No
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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.
Keh-Chung Lin, Sc.D principal investigator
National Taiwan University
5 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 and augmented reality (AR) in people with Stroke Rehabilitation, run by National Taiwan University Hospital at 5 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 10 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: looking for participants now, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keh-Chung Lin, Sc.D (+886-3366-8180, kehchunglin@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Fugl-Meyer Assessment (FMA) at 3 weeks, 6 weeks, 9 weeks, and 21 weeks. (time frame: Baseline, 3 weeks, 6 weeks, 9 weeks, and 21 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 NCT05467813, 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 18 Jun 2025.