StrokeNCT05580744
Augmented-reality Based Mirror Therapy in Stroke Rehabilitation
A study testing Traditional occupational therapy, Mirror therapy using a mirror box and Augmented reality-based mirror therapy in people with Stroke and Rehabilitation, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
In the proposed study, the investigators assumed that mirror therapy combined with augmented reality technology will provide a better treatment effects than traditional mirror therapy for the patients with unilateral stroke. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Rehabilitation, Technology
- What is being tested?
- Traditional occupational therapy, Mirror therapy using a mirror box and Augmented reality-based mirror therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Jan 2023to 27 May 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of stroke with unilateral side involved;
- A score of Mini-mental state examination greater than 24 for proving higher mental function
- Time of onset > 6 months before treatment begins; and
- Premorbid right-handedness.
Who cannot join
- Severe vision impairment;
- Major cognitive-perceptual deficit;
- Other brain disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Augmented-reality Based Mirror Therapy on Sensorimotor Function of Upper Extremity
In the proposed study, the investigators assumed that mirror therapy combined with augmented reality technology will provide a better treatment effects than traditional mirror therapy for the patients with unilateral stroke. The aim of the study is to examine the difference in the treatment effects among the combination of task-oriented training with either augmented reality based mirror therapy, mirror therapy or traditional occupational therapy on the upper extremity function and brain activity of the stroke patients.
- Conditions
- Stroke, Rehabilitation, Technology, Mirror Movement Therapy
- Being tested
- Traditional occupational therapy, Mirror therapy using a mirror box, Augmented reality-based mirror therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional occupational therapyOther
Motor training targeted to goals that are relevant to the functional needs of the patient
Mirror therapy using a mirror boxOther
Mirror therapy using a mirror box
Augmented reality-based mirror therapyOther
Augmented reality-based mirror therapy
| Study group | Role | What they receive |
|---|---|---|
| Traditional occupational therapy | Active comparator | Traditional occupational therapy delivered skill training related to daily living tasks. Receives: Other: Traditional occupational therapy |
| Mirror therapy using a mirror box | Active comparator | Exercise of mirror therapy included movements of forearm, wrist, fingers and thumb, as well as a tendon gliding exercise using a mirror box . Receives: Other: Mirror therapy using a mirror box |
| Augmented reality-based mirror therapy | Experimental | Exercise of augmented reality-based mirror therapy included movements of forearm, wrist, fingers and thumb, as well as a tendon gliding exercise using an augmented reality mirror therapy system
. Receives: Other: Augmented reality-based mirror therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test
Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.
Measured: baseline, 9 weeks and 21 weeks
Secondary outcomes (4)
Change in the result of Modified Ashworth scale (MAS)
Muscle tone is defined by the resistance of a muscle being stretched without resistance. The MAS scores were distributed across the entire scale, ranging from 0 to 4, that is convenient for the clinician use. The grading of the scale is described as below: 0) no increase in muscle tone; 1) minimal resistance at the end of the range of motion; 1+) slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the reminder (less than half) of the ROM; 2) more marked increase in tone but only after part is easily flexed; 3) considerable increase in tone; and 4) passive movement is difficult and affected part is rigid in flexion or extension.
Measured: baseline, 9 weeks and 21 weeks
Change in the result of Box and blocks test
The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.
Measured: baseline, 9 weeks and 21 weeks
Change in the result of Semmes-Weinstein monofilament (SWM) test
The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.
Measured: baseline, 9 weeks and 21 weeks
Change in the result of Motor Activity Log
Semi-structured interview examine how much and how well the subject uses their more-affected arm for 30 ADLs. Score range from 0-5. Higher values represent a better outcome.
Measured: baseline, 9 weeks and 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start3 Jan 2023
- Primary completion8 May 2024
- Study completion27 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580744
- Sponsor's protocol ID
- B-ER-111-246
- Status last verified
- Nov 2023
- First submitted
- 6 Oct 2022
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Augmented-reality Based Mirror Therapy on Sensorimotor Function of Upper Extremity
- ClinicalTrials.gov ID
- NCT05580744
- Acronym / sponsor ID
- B-ER-111-246
- Conditions
- Stroke, Rehabilitation, Technology, Mirror Movement Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 14 Oct 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.
In the proposed study, the investigators assumed that mirror therapy combined with augmented reality technology will provide a better treatment effects than traditional mirror therapy for the patients with unilateral stroke. The aim of the study is to examine the difference in the treatment effects among the combination of task-oriented training with either augmented reality based mirror therapy, mirror therapy or traditional occupational therapy on the upper extremity function and brain activity of the stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional occupational therapy | Active comparator | Other: Traditional occupational therapyTraditional occupational therapy delivered skill training related to daily living tasks. |
| Mirror therapy using a mirror box | Active comparator | Other: Mirror therapy using a mirror boxExercise of mirror therapy included movements of forearm, wrist, fingers and thumb, as well as a tendon gliding exercise using a mirror box . |
| Augmented reality-based mirror therapy | Experimental | Other: Augmented reality-based mirror therapyExercise of augmented reality-based mirror therapy included movements of forearm, wrist, fingers and thumb, as well as a tendon gliding exercise using an augmented reality mirror therapy system . |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of stroke with unilateral side involved;
- A score of Mini-mental state examination greater than 24 for proving higher mental function
- Time of onset > 6 months before treatment begins; and
- Premorbid right-handedness.
Key exclusion criteria (3 listed)
- Severe vision impairment;
- Major cognitive-perceptual deficit;
- Other brain disease.
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 |
|---|---|---|
| Traditional occupational therapyMotor training targeted to goals that are relevant to the functional needs of the patient | Other | Traditional occupational therapy |
| Mirror therapy using a mirror boxMirror therapy using a mirror box | Other | Mirror therapy using a mirror box |
| Augmented reality-based mirror therapyAugmented reality-based mirror therapy | Other | Augmented reality-based mirror therapy |
Primary outcome
Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test
Time frame: baseline, 9 weeks and 21 weeks
Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.
4 secondary outcomes
Change in the result of Modified Ashworth scale (MAS)
Time frame: baseline, 9 weeks and 21 weeks
Change in the result of Box and blocks test
Time frame: baseline, 9 weeks and 21 weeks
Change in the result of Semmes-Weinstein monofilament (SWM) test
Time frame: baseline, 9 weeks and 21 weeks
Change in the result of Motor Activity Log
Time frame: baseline, 9 weeks and 21 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 16 Dec 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional occupational therapy, Mirror therapy using a mirror box and Augmented reality-based mirror therapy in people with Stroke and Rehabilitation, run by National Cheng-Kung University Hospital at 1 site 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 4 inclusion and 3 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 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test (time frame: baseline, 9 weeks and 21 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2024; AzTrials last refreshed its copy on 31 Oct 2026.