StrokeNCT04813120
Digital Mirror Therapy With Uni- and Bilateral Mirror Visual Feedback After Stroke: Treatment Effects and EEG Evidence
A study testing Uni-MVF condition and unimanual training mode using the new MT system (UM-UT), Uni-MVF condition and bimanual training mode using the new MT system (UM-BT) and Bi-MVF condition and bimanual training mode using the new MT system (BM-BT) in people with Stroke and Cerebrovascular Disorders, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
Trial summary
The specific study aims will be: 1. To examine the treatment effects of a new digital mirror therapy (MT) system versus a mirror box in patients with stroke by conducting a 4-group randomized controlled trial. 2. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke, Cerebrovascular Disorders, Central Nervous System Diseases
- What is being tested?
- Uni-MVF condition and unimanual training mode using the new MT system (UM-UT), Uni-MVF condition and bimanual training mode using the new MT system (UM-BT) and Bi-MVF condition and bimanual training mode using the new MT system (BM-BT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Aug 2021to 31 Jul 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with a unilateral stroke;
- at least 6 months after stroke onset;
- age between 20 and 80 years old;
- having a baseline score of Fugl-Meyer Assessment (FMA) in a range of 20 to 60;
- able to follow the study instructions;
- capable of participating in therapy and assessment sessions
Show all 12Show fewer
- diagnosed with a unilateral stroke;
- at least 2 weeks after stroke onset and medical stable;
- aged 20 to 80 years;
- having a baseline score of FMA ≥ 40 and wrist flexion ≥ 20 degrees in order to perform EEG motor tasks;
- both wrist flexion and extension scores of Modified Ashworth Scale ≤ 1;
- able to follow the study instructions
Who cannot join
- global or receptive aphasia;
- severe neglect measured by line bisection test;
- other major medical diseases or comorbidities that have influenced upper-limb usage or caused severe pain
- Part II: Investigation of the Electrophysiological Mechanisms Underlying Different MVF Conditions by EEG
- global or receptive aphasia;
- severe neglect measured by line bisection test;
- other major medical diseases or comorbidities, such as neurological and psychiatric diseases, that have caused severe pain of upper-limb or interfered brain neural activities
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Lo-Sheng Sanatorium and Hospital
Taoyuan City, Taoyuan, 333
Taoyuan Chang Gung Memorial Hospital
Taoyuan City, 333
About this study
Official title: The Use of a New Digital Mirror Therapy System Providing Unilateral and Bilateral Mirror Visual Feedback for Patients With Stroke: Treatment Effects and EEG-physiological Evidence
The specific study aims will be:
- To examine the treatment effects of a new digital mirror therapy (MT) system versus a mirror box in patients with stroke by conducting a 4-group randomized controlled trial.
- To examine the electrophysiological mechanisms of uni-mirror visual feedback (uni-MVF) condition with unimanual training mode, uni-MVF condition with bimanual training mode, and bi-MVF condition with bimanual training mode in the new MT system by EEG.
Read the detailed description
Part I: Validation of Treatment Efficacy of the New Digital MT System with Different MVF Conditions and Training Modes
In this new MT system, 3 different types of MT in different MVF conditions and training modes can be provided: unilateral MVF with unimanual training mode (UM-UT), unilateral MVF with bimanual training mode (UM-BT), and bilateral MVF with bimanual training mode (BM-BT). In the part Ⅰ study, an estimated total of 80 patients with stroke will be recruited. In addition to the original rehabilitation interventions of patients, each participant will be randomly allocated to 1 of 4 intervention groups (i.e., UM-UT, UM-BT, BM-BT, or traditional MT using a mirror box) for 15-hour therapy sessions. Outcome measures will be administrated at pre-treatment, immediately after treatment, and at 1-month follow-up after treatment.
Part II: Investigation of the Electrophysiological Mechanisms Underlying Different MVF Conditions by EEG
Twenty stroke patients will be recruited for examining the brain electrophysiological mechanisms underlying different types of MVF and training conditions of this new system by using electroencephalography (EEG). Three experimental conditions, including UM-UT, UM-BT, and BM-BT conditions, will be conducted in the EEG study.
- Being tested
- Uni-MVF condition and unimanual training mode using the new MT system (UM-UT), Uni-MVF condition and bimanual training mode using the new MT system (UM-BT), Bi-MVF condition and bimanual training mode using the new MT system (BM-BT), Traditional MT using a mirror box
- Keywords
- digital rehabilitation, cerebrovascular accident, mirror visual feedback, brain electrophysiology
- Medical subject headings
- Stroke, Cerebrovascular Disorders, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uni-MVF condition and unimanual training mode using the new MT system (UM-UT)Behavioural
For the UM-UT group, the participants will be seated in front of the new MT system, and will be instructed to watch the real-time image reflection of movements of the non-affected arm and hand on the screen carefully. At the same time, the patients will need to imagine that the movements were performed by their affected arm and hand. In this group, only the non-affected arm and hand will need to perform the movements, but the affected one will not need to move.
Uni-MVF condition and bimanual training mode using the new MT system (UM-BT)Behavioural
During the UM-BT, as similar as the first group (UM-UT), the participants will be also seated in front of the new MT system, and be instructed to watch the real-time image reflection of the non-affected arm and hand's movements on the screen carefully and imagine that the movements were performed by the affected arm. However, in this UM-BT group, the bilateral training mode is emphasized, and thus both arms and hands will need to move. That is, during therapy, the patient's affected arm and hand will be required to move at his/her best motor ability with the non-affected arm and hand at the same time.
Bi-MVF condition and bimanual training mode using the new MT system (BM-BT)Behavioural
For the BM-BT group, the participants will be seated in front of this new MT system, and be instructed to observe the real-time image reflection of the non-affected arm and hand's movements transformed and superimposed on both arms and hands (i.e., bi-MVF), and to imagine that the movements were performed by both arms and hands. In this group, bi-MVF and bilateral training mode are emphasized, and thus both arms and hands will also need to move. The patient's affected arm and hand will be required to move as could as possible simultaneously.
Traditional MT using a mirror boxBehavioural
During traditional MT, the participants will be seated in front of a mirror box placed at their mid-sagittal plane. The affected arm and hand of the participants will be placed inside the mirror box, and the non-affected arm and hand will be in front of the mirror. As similar to the UM-UT group, the participants will be instructed to watch the mirror reflection of the movements performed by the non-affected arm and hand carefully and to imagine that the movements were performed by the affected arm and hand. In this group, the patient's affected arm and hand inside the mirror box will not need to move.
| Study group | Role | What they receive |
|---|---|---|
| Uni-MVF condition and unimanual training mode using the new MT system (UM-UT) | Experimental | The following common categories of upper-limb movements and actions will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movements, and (c) object manipulation. Receives: Behavioral: Uni-MVF condition and unimanual training mode using the new MT system (UM-UT) |
| Uni-MVF condition and bimanual training mode using the new MT system (UM-BT) | Experimental | The following common categories of upper-limb movements and actions will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movements, and (c) object manipulation. Receives: Behavioral: Uni-MVF condition and bimanual training mode using the new MT system (UM-BT) |
| Bi-MVF condition and bimanual training mode using the new MT system (BM-BT) | Experimental | The following common categories of upper-limb movements and actions will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movements, and (c) object manipulation. Receives: Behavioral: Bi-MVF condition and bimanual training mode using the new MT system (BM-BT) |
| Traditional MT using a mirror box | Active comparator | The following common categories of upper-limb movements and actions will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movements, and (c) object manipulation. Receives: Behavioral: Traditional MT using a mirror box |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change scores of Fugl-Meyer Assessment
The upper-limb subsection of Fugl-Meyer Assessment is a measure with sound psychometric properties to evaluate motor impairments.
Measured: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
Change scores of Chedoke Arm and Hand Activity Inventory
The Chedoke Arm and Hand Activity Inventory is a reliable and validated measure to assess the independence of stroke patients to perform activities of daily living with an affected upper limb.
Measured: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
Secondary outcomes (7)
change scores of Box and Block Test
The Box and Block Test is a tool with sound reliability and validity to evaluate hand dexterity of stroke patients.
Measured: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
change scores of Revised Nottingham Sensory Assessment
The Revised Nottingham Sensory Assessment is a standardized measure with good reliability to assess sensory function in patients with stroke.
Measured: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
change scores of Movement Imagery Questionnaire-Revised, Second Edition
The Movement Imagery Questionnaire-Revised, Second Edition is a 14-item questionnaire with sound reliability and validity to evaluate the ability of motion imagination in patients with stroke.
Measured: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
change scores of Barthel Index
The Barthel Index is a validated tool designed to measure activities reflecting the daily living independence.
Measured: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
change scores of Motor Activity Log
The Motor Activity Log is a semi-structured interview with good psychometric properties to assess the level of use of affected upper limb in 30 main activities of daily living.
Measured: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
change scores of the health state of EQ-5D-5L
The questionnaire of EQ-5D-5L contains 5 dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and uses a 5-point Likert scale scored from 1 (no problem) to 5 (unable to/extreme problems); whereas, the numerical description of 5 dimensions represents the health state.
Measured: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
change scores of the visual analogue scale (VAS) of EQ-5D-5L
The VAS of EQ-5D-5L scores will be scored from 0 to 100, with a higher score indicating better overall current health.
Measured: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Aug 2021
- Primary completion31 Jul 2024
- Study completion31 Jul 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Wei Hsieh, PhD, Principal investigator, Department of Occupational Therapy, College of Medicine, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813120
- Sponsor's protocol ID
- 202002234A3
- Status last verified
- Aug 2023
- First submitted
- 21 Mar 2021
- Last updated
- 21 Aug 2024
- Results posted
- 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a New Digital Mirror Therapy System Providing Unilateral and Bilateral Mirror Visual Feedback for Patients With Stroke: Treatment Effects and EEG-physiological Evidence
- ClinicalTrials.gov ID
- NCT04813120
- Acronym / sponsor ID
- 202002234A3
- Keywords
- digital rehabilitation, cerebrovascular accident, mirror visual feedback, brain electrophysiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 24 Mar 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.
The specific study aims will be:
- To examine the treatment effects of a new digital mirror therapy (MT) system versus a mirror box in patients with stroke by conducting a 4-group randomized controlled trial.
- To examine the electrophysiological mechanisms of uni-mirror visual feedback (uni-MVF) condition with unimanual training mode, uni-MVF condition with bimanual training mode, and bi-MVF condition with bimanual training mode in the new MT system by EEG.
Detailed description
Part I: Validation of Treatment Efficacy of the New Digital MT System with Different MVF Conditions and Training Modes
In this new MT system, 3 different types of MT in different MVF conditions and training modes can be provided: unilateral MVF with unimanual training mode (UM-UT), unilateral MVF with bimanual training mode (UM-BT), and bilateral MVF with bimanual training mode (BM-BT). In the part Ⅰ study, an estimated total of 80 patients with stroke will be recruited. In addition to the original rehabilitation interventions of patients, each participant will be randomly allocated to 1 of 4 intervention groups (i.e., UM-UT, UM-BT, BM-BT, or traditional MT using a mirror box) for 15-hour therapy sessions. Outcome measures will be administrated at pre-treatment, immediately after treatment, and at 1-month follow-up after treatment.
Part II: Investigation of the Electrophysiological Mechanisms Underlying Different MVF Conditions by EEG
Twenty stroke patients will be recruited for examining the brain electrophysiological mechanisms underlying different types of MVF and training conditions of this new system by using electroencephalography (EEG). Three experimental conditions, including UM-UT, UM-BT, and BM-BT conditions, will be conducted in the EEG study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Uni-MVF condition and unimanual training mode using the new MT system (UM-UT) | Experimental | Behavioral: Uni-MVF condition and unimanual training mode using the new MT system (UM-UT)The following common categories of upper-limb movements and actions will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movements, and (c) object manipulation. |
| Uni-MVF condition and bimanual training mode using the new MT system (UM-BT) | Experimental | Behavioral: Uni-MVF condition and bimanual training mode using the new MT system (UM-BT)The following common categories of upper-limb movements and actions will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movements, and (c) object manipulation. |
| Bi-MVF condition and bimanual training mode using the new MT system (BM-BT) | Experimental | Behavioral: Bi-MVF condition and bimanual training mode using the new MT system (BM-BT)The following common categories of upper-limb movements and actions will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movements, and (c) object manipulation. |
| Traditional MT using a mirror box | Active comparator | Behavioral: Traditional MT using a mirror boxThe following common categories of upper-limb movements and actions will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movements, and (c) object manipulation. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- diagnosed with a unilateral stroke;
- at least 6 months after stroke onset;
- age between 20 and 80 years old;
- having a baseline score of Fugl-Meyer Assessment (FMA) in a range of 20 to 60;
- able to follow the study instructions;
Key exclusion criteria (7 listed)
- global or receptive aphasia;
- severe neglect measured by line bisection test;
- other major medical diseases or comorbidities that have influenced upper-limb usage or caused severe pain
- Part II: Investigation of the Electrophysiological Mechanisms Underlying Different MVF Conditions by EEG
- global or receptive aphasia;
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 |
|---|---|---|
| Uni-MVF condition and unimanual training mode using the new MT system (UM-UT)For the UM-UT group, the participants will be seated in front of the new MT system, and will be instructed to watch the real-time image reflection of movements of the non-affected arm and hand on the screen carefully. At the same time, the patients will need to imagine that the movements were performed by their affected arm and hand. In this group, only the non-affected arm and hand will need to perform the movements, but the affected one will not need to move. | Behavioural | Uni-MVF condition and unimanual training mode using the new MT system (UM-UT) |
| Uni-MVF condition and bimanual training mode using the new MT system (UM-BT)During the UM-BT, as similar as the first group (UM-UT), the participants will be also seated in front of the new MT system, and be instructed to watch the real-time image reflection of the non-affected arm and hand's movements on the screen carefully and imagine that the movements were performed by the affected arm. However, in this UM-BT group, the bilateral training mode is emphasized, and thus both arms and hands will need to move. That is, during therapy, the patient's affected arm and hand will be required to move at his/her best motor ability with the non-affected arm and hand at the same time. | Behavioural | Uni-MVF condition and bimanual training mode using the new MT system (UM-BT) |
| Bi-MVF condition and bimanual training mode using the new MT system (BM-BT)For the BM-BT group, the participants will be seated in front of this new MT system, and be instructed to observe the real-time image reflection of the non-affected arm and hand's movements transformed and superimposed on both arms and hands (i.e., bi-MVF), and to imagine that the movements were performed by both arms and hands. In this group, bi-MVF and bilateral training mode are emphasized, and thus both arms and hands will also need to move. The patient's affected arm and hand will be required to move as could as possible simultaneously. | Behavioural | Bi-MVF condition and bimanual training mode using the new MT system (BM-BT) |
| Traditional MT using a mirror boxDuring traditional MT, the participants will be seated in front of a mirror box placed at their mid-sagittal plane. The affected arm and hand of the participants will be placed inside the mirror box, and the non-affected arm and hand will be in front of the mirror. As similar to the UM-UT group, the participants will be instructed to watch the mirror reflection of the movements performed by the non-affected arm and hand carefully and to imagine that the movements were performed by the affected arm and hand. In this group, the patient's affected arm and hand inside the mirror box will not need to move. | Behavioural | Traditional MT using a mirror box |
Primary outcome
Change scores of Fugl-Meyer Assessment
Time frame: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
The upper-limb subsection of Fugl-Meyer Assessment is a measure with sound psychometric properties to evaluate motor impairments.
Change scores of Chedoke Arm and Hand Activity Inventory
Time frame: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
The Chedoke Arm and Hand Activity Inventory is a reliable and validated measure to assess the independence of stroke patients to perform activities of daily living with an affected upper limb.
7 secondary outcomes
change scores of Box and Block Test
Time frame: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
change scores of Revised Nottingham Sensory Assessment
Time frame: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
change scores of Movement Imagery Questionnaire-Revised, Second Edition
Time frame: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
change scores of Barthel Index
Time frame: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
change scores of Motor Activity Log
Time frame: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
change scores of the health state of EQ-5D-5L
Time frame: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
change scores of the visual analogue scale (VAS) of EQ-5D-5L
Time frame: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
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 21 Aug 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.
Yu-Wei Hsieh, PhD principal investigator
Department of Occupational Therapy, College of Medicine, Chang Gung University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uni-MVF condition and unimanual training mode using the new MT system (UM-UT), Uni-MVF condition and bimanual training mode using the new MT system (UM-BT) and Bi-MVF condition and bimanual training mode using the new MT system (BM-BT) in people with Stroke and Cerebrovascular Disorders, run by Chang Gung Memorial 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 12 inclusion and 7 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 21 Aug 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 scores of Fugl-Meyer Assessment (time frame: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)). 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?
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 21 Aug 2024.