Stroke RehabilitationNCT05993091
Mirror Therapy and Augmented Reality in Stroke Rehabilitation
A study testing mirror therapy (MT) and augmented reality (AR) in people with Stroke Rehabilitation, run by National Taiwan University Hospital at 5 sites in Taiwan.
Trial summary
This 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 30 to 80 years
- Conditions the study is for
- Stroke Rehabilitation
- What is being tested?
- mirror therapy (MT) and augmented reality (AR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 5 sitesTaiwan
- Study dates
- 5 May 2023to 31 Dec 2026
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a first-ever unilateral stroke ≥3 months and ≤3 years
- age between 30 and 80 years (Kwakkel et al., 1999)
- baseline Fugl-Meyer Assessment Upper Extremity (FMA-UE) score >10 (Fugl-Meyer et al., 1975)
- no severe spasticity in any joints of the affected arm (modified Ashworth scale <3) (Charalambous, 2014)
- ability to follow the instructions of the evaluator and therapists
- the ability to maintain a step-standing position for at least 30 seconds (Lloréns et al., 2015)
Show all 10Show fewer
- ability to walk a minimum of 10 meters, with or without a device (Park et al., 2017)
- no severe vision impairments or other major neurologic diseases
- no participation in other studies during the study period
- 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 Hospital, Ministry of Health and Welfare
New Taipei City
Keh-chung Lin, ScD, +886 33668180, kehchunglin@ntu.edu.tw
- Recruiting
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation
New Taipei City
Keh-chung Lin, ScD, +886-3366-8180, kehchunglin@ntu.edu.tw
- Recruiting
Fongyuan Hospital, Ministry of Health and Welfare
Taichung
Keh-chung Lin, ScD, +886-3366-8180, kehchunglin@ntu.edu.tw
- Recruiting
National Taiwan University Hospital
Taipei
Keh-chung Lin, ScD, +886 33668180, kehchunglin@ntu.edu.tw
- Recruiting
Wan Fang Hospital, Taipei Medical University
Taipei
Keh-chung Lin, ScD, +886-3366-8180, kehchunglin@ntu.edu.tw
About this study
Official title: Outcomes of Mirror Therapy Preceding Augmented Reality in Stroke Rehabilitation
This 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 multidimensional needs of patients with stroke, hybrid interventions that combine different approaches are needed due to the complexity of stroke. Our previous research funded by the NHRI has been published and translated to stroke rehabilitation, particularly in the priming and synergic effects of robotic-assisted training and/or mirror therapy (MT). To extend from our previous research, the investigators will combine MT with augmented reality (AR), an emerging adjunct therapy in stroke rehabilitation. An AR-based intervention provides an intensive, repetitive, and context-rich training program, leading to an interesting environment with real-time feedback to increase motivation and participation.
Read the detailed description
This proposed research is in line with the prioritized need 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 multidimensional needs of patients with stroke, hybrid interventions that combine different approaches are needed due to the complexity of stroke. Our previous research funded by the NHRI has been published and translated to stroke rehabilitation, particularly in the priming and synergic effects of robotic-assisted training and/or mirror therapy (MT). To extend from our previous research, the investigators will combine MT with augmented reality (AR), an emerging adjunct therapy in stroke rehabilitation. An AR-based intervention provides an intensive, repetitive, and context-rich training program, leading to an interesting environment with real-time feedback to increase motivation and participation.
Current stroke rehabilitation programs, such as MT and AR and their combination, are novel intervention approaches that have promise for feedback-enhanced stroke rehabilitation. MT 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. AR is powered by its potential to provide an intensive, repetitive, and context-rich training program and promote motor, mobility, and cognition function recovery. MT and AR can be complementary for formulating a hybrid regimen. MT has been implemented conventionally by being based on a bilateral approach. Our innovative protocol will include both unilateral and bilateral MT using personally relevant task objects for improving task performance. The goals of this proposed research project will be to (1) compare treatment efficacy between the hybrid approaches of MT preceding AR (MT+AR), AR-based intervention (AR), and dose-matched conventional therapy (CT) on sensory and motor function, mobility, daily function, life quality, and self-efficacy in stroke patients, and (2) identify the potential predictors of treatment success using chi-squared automatic interaction detection (CHAID). This project is a single-blinded three-armed randomized controlled trial. The investigators plan to recruit 128 stroke survivors who will be randomly allocated to one of the experimental (MT+AR), comparison (AR), or control (CT) groups. The experimental group will receive 40 minutes of MT, followed by 40 minutes of AR training and 10 minutes of functional practice. The comparison group will receive 80 minutes of AR training combined with 10 minutes of functional practice. The control group will have 90 minutes of conventional occupational therapy, including 10 minutes of functional practice.
All participants will receive interventions for 90 minutes/day, 3 days/week for 6 weeks. There will be three assessment time points: baseline, immediately after the intervention, and the 3-month follow-up. The primary outcome measures are the upper-extremity subscale of the Fugl-Meyer Assessment and Berg Balance Scale. Under the International Classification of Functioning, Disability and Health (ICF) framework, the investigators will also include sensory impairment, actual arm use, daily activity function, self-efficacy, and quality of life as the secondary outcomes. Analysis of covariance controlling the baseline scores will be used to analyze the immediate and retention effects between treatment groups. After determining the minimal clinically important difference (MCID) in the primary outcomes using anchor- and distribution-based methods, the investigators will further use CHAID to identify the significant predictors and the corresponding cutoff points to differentiate those who have a greater likelihood to respond to treatment. The investigators expect to provide robust evidence for the hybrid regimen of MT-primed AR to boost poststroke patients' recovery in sensory/motor impairment, dysfunction in daily activities, low self-efficacy, and poor health-related quality of life. Specifically, the priming effect of mirror visual feedback is anticipated to be supported by showing a larger effect size in the MT+AR group compared with the AR and CT group. Based on the clinical trial data of our proposed project, the investigators will determine the MCIDs specific to the outcomes of MT/AR and further conduct the CHAID analysis to identify critical predicting factor of treatment success. The findings will update evidence-based stroke care advocated by the Ministry of Health and Welfare and be used to translate the evidence into clinical practice and decision making in precision stroke rehabilitation.
- Conditions
- Stroke Rehabilitation
- Being tested
- mirror therapy (MT), augmented reality (AR), Control intervention
- Keywords
- stroke, rehabilitation, mirror therapy, augemnted reality
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirror therapy (MT)Other
Each participant will practice two different MT protocols: UMT and BMT. During UMT, the affected hand is static, whereas 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 (i.e., shoulder flexion, elbow flexion/extension, forearm pronation/supination, and wrist flexion/extension and circumduction), fine motor movements (i.e., opposition, grasp, and release), and object manipulation (i.e., reaching out to grasp a cup, flipping coins).
augmented reality (AR)Other
The training program with different levels of difficulty provides goal-directed exercises designed to be adjustable in order to match the patient's ability to minimize compensatory movements. The goal-directed exercise includes balance training (i.e., weight shifting, standing on one leg, etc.), activities of daily living training (i.e., reaching to grasp functionally relevant objects), 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 interventionOther
Participants will perform 90 minutes of therapist-mediated conventional therapy. The treatment protocols will be formulated by using occupational therapy techniques, such as neurodevelopmental techniques and functional task training. Specifically, the 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 will be used to alleviate functional deficits. In addition, 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 |
|---|---|---|
| MT+AR group | Experimental | The experimental group will receive 40 minutes of MT, followed by 40 minutes of AR training and 10 minutes of functional practice. Figure 2 provides an illustration of the hybrid regimen of MT+AR. Receives: Other: mirror therapy (MT); Other: augmented reality (AR) |
| AR group | Active comparator | The comparison group will receive 80 minutes of AR training combined with 10 minutes of functional practice. Receives: Other: augmented reality (AR) |
| CT group | Active comparator | The control group will receive 90 minutes of conventional occupational therapy, including 10 minutes of functional practice. Examples of functional practice include chopping vegetables, pouring water from a kettle, folding a towel, etc. Receives: Other: Control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment (FMA)
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, 6 weeks, and 18 weeks
Berg Balance Scale (BBS)
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, 6 weeks, and 18 weeks
Secondary outcomes (7)
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: Baseline, 6 weeks, and 18 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: Baseline, 6 weeks, and 18 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 (Silva et al., 2018; Van der Lee et al., 2004). 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 (Silva et al., 2018).
Measured: Baseline, 6 weeks, and 18 weeks
Stroke Impact Scale Version 3.0 (SIS 3.0)
The SIS 3.0 measures stroke-specific health-related quality of life (Duncan et al., 2003). 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 with stroke (Duncan et al., 2003).
Measured: Baseline, 6 weeks, and 18 weeks
Stroke Self-Efficacy Questionnaire (SSEQ)
Self-efficacy is the belief in one's capabilities to organize and execute a plan of action and to complete a task or achieve a goal (Bandura, 1997). The SSEQ measures self-efficacy judgments in functional domains of an individuals' life after stroke (Jones et al., 2008). In this 13-item questionnaire, each item is scored according to the perceived confidence, ranging from 0 (no confidence at all) to 10 (complete confidence). Its validity and reliability have been established in patients with stroke (Dallolio et al., 2018; Jones et al., 2008; Riazi et al., 2014). Recent research has supported the relevance of the SSEQ in outcome evaluations in individuals with stroke (Long et al., 2020; Johar et al., 2022).
Measured: Baseline, 6 weeks, and 18 weeks
Goal Attainment Scale (GAS)
The Goal Attainment Scale (GAS) is an individualized outcome measure used to assess the extent to which participants achieve personalized functional goals established collaboratively with the therapist. Each goal is scored on a 5-point scale ranging from -2 (much less than expected outcome) to +2 (much more than expected outcome), with 0 indicating the expected level of goal attainment. Higher scores indicate better goal achievement.
Measured: Baseline, 6 weeks, and 18 weeks
Stroke-Specific Measure of Adherence to Home-based Exercises (SS-MAHE)
We include this test because adherence to home-based practices is essential for achieving meaningful changes in treatment outcomes (Bassett, 2012). The SS-MAHE is a validated (Mahmood et al., 2020) 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) the dosage of actual practice activities done by the participants. The repetition, frequency, and duration for each activity will be recorded, and the intensity will be indicated using the visual analog scale.
Measured: Baseline, 6 weeks, and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start5 May 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
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, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993091
- Sponsor's protocol ID
- 202303069RINB
- Status last verified
- Dec 2025
- First submitted
- 6 Aug 2023
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin CJ, Lin KC, Lau HY, Hsieh YW, Li YC, Chen WS, Chen CL, Chang YJ, Lee YY, Yao G, Hrong YS, Pan HC, Wu YH, Hsu WL, Kuo CC, Tsai HT, Lin CY, Chang PC. Effects of mirror therapy preceding augmented reality in stroke rehabilitation: a randomized controlled trial. J Neuroeng Rehabil. 2025 Dec 24;23(1):89. doi: 10.1186/s12984-025-01820-8.
PubMed 41444616
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Mirror Therapy Preceding Augmented Reality in Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT05993091
- Acronym / sponsor ID
- 202303069RINB
- Conditions
- Stroke Rehabilitation
- Keywords
- stroke, rehabilitation, mirror therapy, augemnted reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Aug 2023 (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 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 multidimensional needs of patients with stroke, hybrid interventions that combine different approaches are needed due to the complexity of stroke. Our previous research funded by the NHRI has been published and translated to stroke rehabilitation, particularly in the priming and synergic effects of robotic-assisted training and/or mirror therapy (MT). To extend from our previous research, the investigators will combine MT with augmented reality (AR), an emerging adjunct therapy in stroke rehabilitation. An AR-based intervention provides an intensive, repetitive, and context-rich training program, leading to an interesting environment with real-time feedback to increase motivation and participation.
Detailed description
This proposed research is in line with the prioritized need 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 multidimensional needs of patients with stroke, hybrid interventions that combine different approaches are needed due to the complexity of stroke. Our previous research funded by the NHRI has been published and translated to stroke rehabilitation, particularly in the priming and synergic effects of robotic-assisted training and/or mirror therapy (MT). To extend from our previous research, the investigators will combine MT with augmented reality (AR), an emerging adjunct therapy in stroke rehabilitation. An AR-based intervention provides an intensive, repetitive, and context-rich training program, leading to an interesting environment with real-time feedback to increase motivation and participation.
Current stroke rehabilitation programs, such as MT and AR and their combination, are novel intervention approaches that have promise for feedback-enhanced stroke rehabilitation. MT 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. AR is powered by its potential to provide an intensive, repetitive, and context-rich training program and promote motor, mobility, and cognition function recovery. MT and AR can be complementary for formulating a hybrid regimen. MT has been implemented conventionally by being based on a bilateral approach. Our innovative protocol will include both unilateral and bilateral MT using personally relevant task objects for improving task performance. The goals of this proposed research project will be to (1) compare treatment efficacy between the hybrid approaches of MT preceding AR (MT+AR), AR-based intervention (AR), and dose-matched conventional therapy (CT) on sensory and motor function, mobility, daily function, life quality, and self-efficacy in stroke patients, and (2) identify the potential predictors of treatment success using chi-squared automatic interaction detection (CHAID). This project is a single-blinded three-armed randomized controlled trial. The investigators plan to recruit 128 stroke survivors who will be randomly allocated to one of the experimental (MT+AR), comparison (AR), or control (CT) groups. The experimental group will receive 40 minutes of MT, followed by 40 minutes of AR training and 10 minutes of functional practice. The comparison group will receive 80 minutes of AR training combined with 10 minutes of functional practice. The control group will have 90 minutes of conventional occupational therapy, including 10 minutes of functional practice.
All participants will receive interventions for 90 minutes/day, 3 days/week for 6 weeks. There will be three assessment time points: baseline, immediately after the intervention, and the 3-month follow-up. The primary outcome measures are the upper-extremity subscale of the Fugl-Meyer Assessment and Berg Balance Scale. Under the International Classification of Functioning, Disability and Health (ICF) framework, the investigators will also include sensory impairment, actual arm use, daily activity function, self-efficacy, and quality of life as the secondary outcomes. Analysis of covariance controlling the baseline scores will be used to analyze the immediate and retention effects between treatment groups. After determining the minimal clinically important difference (MCID) in the primary outcomes using anchor- and distribution-based methods, the investigators will further use CHAID to identify the significant predictors and the corresponding cutoff points to differentiate those who have a greater likelihood to respond to treatment. The investigators expect to provide robust evidence for the hybrid regimen of MT-primed AR to boost poststroke patients' recovery in sensory/motor impairment, dysfunction in daily activities, low self-efficacy, and poor health-related quality of life. Specifically, the priming effect of mirror visual feedback is anticipated to be supported by showing a larger effect size in the MT+AR group compared with the AR and CT group. Based on the clinical trial data of our proposed project, the investigators will determine the MCIDs specific to the outcomes of MT/AR and further conduct the CHAID analysis to identify critical predicting factor of treatment success. The findings will update evidence-based stroke care advocated by the Ministry of Health and Welfare and be used to translate the evidence into clinical practice and decision making in precision stroke rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MT+AR group | Experimental | Other: mirror therapy (MT), Other: augmented reality (AR)The experimental group will receive 40 minutes of MT, followed by 40 minutes of AR training and 10 minutes of functional practice. Figure 2 provides an illustration of the hybrid regimen of MT+AR. |
| AR group | Active comparator | Other: augmented reality (AR)The comparison group will receive 80 minutes of AR training combined with 10 minutes of functional practice. |
| CT group | Active comparator | Other: Control interventionThe control group will receive 90 minutes of conventional occupational therapy, including 10 minutes of functional practice. Examples of functional practice include chopping vegetables, pouring water from a kettle, folding a towel, etc. |
Who may qualify
- Ages
- 30 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 and ≤3 years
- age between 30 and 80 years (Kwakkel et al., 1999)
- baseline Fugl-Meyer Assessment Upper Extremity (FMA-UE) score >10 (Fugl-Meyer et al., 1975)
- no severe spasticity in any joints of the affected arm (modified Ashworth scale <3) (Charalambous, 2014)
- ability to follow the instructions of the evaluator and therapists
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 therapy (MT)Each participant will practice two different MT protocols: UMT and BMT. During UMT, the affected hand is static, whereas 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 (i.e., shoulder flexion, elbow flexion/extension, forearm pronation/supination, and wrist flexion/extension and circumduction), fine motor movements (i.e., opposition, grasp, and release), and object manipulation (i.e., reaching out to grasp a cup, flipping coins). | Other | MT+AR group |
| augmented reality (AR)The training program with different levels of difficulty provides goal-directed exercises designed to be adjustable in order to match the patient's ability to minimize compensatory movements. The goal-directed exercise includes balance training (i.e., weight shifting, standing on one leg, etc.), activities of daily living training (i.e., reaching to grasp functionally relevant objects), 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 | AR group, MT+AR group |
| Control interventionParticipants will perform 90 minutes of therapist-mediated conventional therapy. The treatment protocols will be formulated by using occupational therapy techniques, such as neurodevelopmental techniques and functional task training. Specifically, the 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 will be used to alleviate functional deficits. In addition, 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 | CT group |
Primary outcome
Fugl-Meyer Assessment (FMA)
Time frame: Baseline, 6 weeks, and 18 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.
Berg Balance Scale (BBS)
Time frame: Baseline, 6 weeks, and 18 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.
7 secondary outcomes
Revised Nottingham Sensory Assessment (rNSA)
Time frame: Baseline, 6 weeks, and 18 weeks
Chedoke Arm and Hand Activity Inventory (CAHAI)
Time frame: Baseline, 6 weeks, and 18 weeks
Motor Activity Log (MAL)
Time frame: Baseline, 6 weeks, and 18 weeks
Stroke Impact Scale Version 3.0 (SIS 3.0)
Time frame: Baseline, 6 weeks, and 18 weeks
Stroke Self-Efficacy Questionnaire (SSEQ)
Time frame: Baseline, 6 weeks, and 18 weeks
Goal Attainment Scale (GAS)
Time frame: Baseline, 6 weeks, and 18 weeks
Stroke-Specific Measure of Adherence to Home-based Exercises (SS-MAHE)
Time frame: Baseline, 6 weeks, and 18 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 5 Feb 2026.
- Derived from this study: PubMed 41444616Lin CJ, Lin KC, Lau HY, Hsieh YW, Li YC, Chen WS, Chen CL, Chang YJ, Lee YY, Yao G, Hrong YS, Pan HC, Wu YH, Hsu WL, Kuo CC, Tsai HT, Lin CY, Chang PC. Effects of mirror therapy preceding augmented reality in stroke rehabilitation: a randomized controlled trial. J Neuroeng Rehabil. 2025 Dec 24;23(1):89. doi: 10.1186/s12984-025-01820-8.
- 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, ScD principal investigator
National Taiwan University Hospital
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 (MT) 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 5 Feb 2026. 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, ScD (+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?
Fugl-Meyer Assessment (FMA) (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 NCT05993091, 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 5 Feb 2026.