StrokeNCT05796843
360 Degrees Virtual Reality-based Mirror Therapy for Stroke Patients
A study testing 360 Degrees virtual reality-based mirror therapy, Traditional mirror therapy and Conventional Physical Therapy in people with Stroke and Stroke Rehabilitation, run by Sahmyook University at 1 site in South Korea.
Trial summary
The goal of this randomized controlled trial is to compare the effects of 360 degree virtual reality-based mirror therapy (360MT) to traditional mirror therapy (TMT) and conventional physical therapy (control group) on upper extremity function among stroke patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Stroke Rehabilitation, Mirror Movement Therapy
- What is being tested?
- 360 Degrees virtual reality-based mirror therapy, Traditional mirror therapy and Conventional Physical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2023to 4 May 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- who have not passed 12 months since onset;
- who can understand and follow instructions;
- who have ≥21 scores in Korean version of Mini-Mental State Examination (MMSE-K);
- who have mild to moderate motor impairment according to the Fugl Meyer Assessment (FMA) scores
Who cannot join
- patients who have any kinds of mental disorder and/or Alzheimer's disease;
- who have orthopedic and/or musculoskeletal injury;
- who have apraxia; and
- who have previous experiences of participating in investigations and/or mirror therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 360 Degrees Virtual Reality-based Mirror Therapy for Upper Extremity Rehabilitation Among Stroke Patients
The goal of this randomized controlled trial is to compare the effects of 360 degree virtual reality-based mirror therapy (360MT) to traditional mirror therapy (TMT) and conventional physical therapy (control group) on upper extremity function among stroke patients.
The main questions it aims to answer are:
Read more
- Would 360MT be more effective when treated for 4 weeks in outcome measure ments including: Fugl-Meyer Assessment for upper extremity (FMA-UE); manual function test (MFT); and box \& block test (BBT)?
- How would particants' experience be in terms of satisfactory and enjoyment during 360MT?
The study will have three groups of participants who will be involved in different tasks:
- 360MT group: will receive mirror therapy using a virtual reality device (HMD) and perform tasks with their paralyzed hand. Sessions will last 30 minutes, 3 times a week for 4 weeks.
- TMT group: will receive mirror therapy using an acrylic mirror and perform finger, wrist, elbow exercises using their paralyzed limb. Sessions will last 30 minutes, 3 times a week for 4 weeks.
- Control group: will receive conventional physical therapy consisting of exercises for the upper extremity, 60 minutes per day, 5 sessions a week, for 4 weeks.
- Conditions
- Stroke, Stroke Rehabilitation, Mirror Movement Therapy
- Being tested
- 360 Degrees virtual reality-based mirror therapy, Traditional mirror therapy, Conventional Physical Therapy
- Keywords
- Stroke, Stroke Rehabilitation, Mirror Movement Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
360 Degrees virtual reality-based mirror therapyProcedure or surgery
Participants will receive mirror therapy using a virtual reality device (Pico G2 VR 4K, Pico, China). They will be asked to follow tasks that are played in HMD using their paralyzed hand. The video played using HMD will be video taped using 360 degree camera prior to the treatment. The 360MT will last 30 minutes/session, 3 sessions a week for 4 weeks. The tasks are finger flexion-extension, wrist flexion-extension and pronation-supination, and elbow flexion-extension for ten repetitions.
Traditional mirror therapyProcedure or surgery
Participants will receive mirror therapy using an acrylic mirror (40cm x 40cm x 3cm) that reflects unparalyzed side of them. They will be asked to perform tasks including finger flexion-extension, wrist flexion-extension and pronation-supination, and elbow flexion-extension for ten repetitions. They will be asked to follow the reflection on mirror using their paralyzed limb. The TMT will last 30 minutes/session, 3 sessions a week for 4 weeks.
Conventional Physical TherapyProcedure or surgery
Participants will receive conventional physical therapy including neurodevelopmental therapy, muscle strengthening exercises, and joint mobilization which will be provided 60 minutes per day, 5 sessions a week, for 4 weeks. The therapy will follow upper extremity rehabilitation protocol which consists of three phases of warm up, circuit, and cool down exercises
| Study group | Role | What they receive |
|---|---|---|
| 360 Degrees Virtual Reality-based Mirror Therapy Group | Experimental | The group which will receive 360 Degrees Virtual Reality-based Mirror Therapy Group Receives: Procedure: 360 Degrees virtual reality-based mirror therapy; Procedure: Conventional Physical Therapy |
| Traditional Mirror Therapy Group | Active comparator | The group which will receive traditional mirror therapy using a conventional mirror Receives: Procedure: Traditional mirror therapy; Procedure: Conventional Physical Therapy |
| Conventional Physical Therapy Group | Active comparator | The group which will receive conventional rehabilitation for upper extremity Receives: Procedure: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment for upper extremity (FMA-UE)
The test is one of the most frequently used evaluation tools that quantitatively assesses recovery after stroke by measuring motor skills, balance ability, sensory function, and range of motion. The maximum total score for FMA-UE is 66 points, containing 18 items to evaluate shoulder, elbow, and forearm; 5 for the wrist; 7 for the hand; and 3 items for coordination.
Measured: Changes from baseline after 4 weeks of intervention
Secondary outcomes (2)
Manual Function Test (MFT)
This test can reflect the degree of upper extremity dysfunction after stroke, consists of four items each for shoulder and hands. The MFT has a maximum total score of 32 points
Measured: Changes from baseline after 4 weeks of intervention
Box & Block Test (BBT)
used to evaluate manual dexterity of the hands. The evaluation involves wooden blocks (2.5 cm3) placed in a box (53.7cm x 8.5 cm x 27.4cm) which is divided by a partition in the center. The subjects were instructed to move as many boxes as possible from one side to another in one minute using their affected upper limbs.
Measured: Changes from baseline after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start1 Apr 2023
- Primary completion4 May 2023
- Study completion4 May 2023
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sungbae Jo, Sahmyook University
- Investigators
- Sungbae Jo, PhD candidate, Principal investigator, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796843
- Sponsor's protocol ID
- SYU 2023-01-009-001
- Status last verified
- May 2023
- First submitted
- 16 Mar 2023
- Last updated
- 6 May 2023
- 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 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 360 Degrees Virtual Reality-based Mirror Therapy for Upper Extremity Rehabilitation Among Stroke Patients
- ClinicalTrials.gov ID
- NCT05796843
- Acronym / sponsor ID
- SYU 2023-01-009-001
- Conditions
- Stroke, Stroke Rehabilitation, Mirror Movement Therapy
- Keywords
- Stroke, Stroke Rehabilitation, Mirror Movement Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 4 Apr 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.
The goal of this randomized controlled trial is to compare the effects of 360 degree virtual reality-based mirror therapy (360MT) to traditional mirror therapy (TMT) and conventional physical therapy (control group) on upper extremity function among stroke patients.
The main questions it aims to answer are:
- Would 360MT be more effective when treated for 4 weeks in outcome measure ments including: Fugl-Meyer Assessment for upper extremity (FMA-UE); manual function test (MFT); and box \& block test (BBT)?
- How would particants' experience be in terms of satisfactory and enjoyment during 360MT?
The study will have three groups of participants who will be involved in different tasks:
- 360MT group: will receive mirror therapy using a virtual reality device (HMD) and perform tasks with their paralyzed hand. Sessions will last 30 minutes, 3 times a week for 4 weeks.
- TMT group: will receive mirror therapy using an acrylic mirror and perform finger, wrist, elbow exercises using their paralyzed limb. Sessions will last 30 minutes, 3 times a week for 4 weeks.
- Control group: will receive conventional physical therapy consisting of exercises for the upper extremity, 60 minutes per day, 5 sessions a week, for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 360 Degrees Virtual Reality-based Mirror Therapy Group | Experimental | Procedure: 360 Degrees virtual reality-based mirror therapy, Procedure: Conventional Physical TherapyThe group which will receive 360 Degrees Virtual Reality-based Mirror Therapy Group |
| Traditional Mirror Therapy Group | Active comparator | Procedure: Traditional mirror therapy, Procedure: Conventional Physical TherapyThe group which will receive traditional mirror therapy using a conventional mirror |
| Conventional Physical Therapy Group | Active comparator | Procedure: Conventional Physical TherapyThe group which will receive conventional rehabilitation for upper extremity |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- who have not passed 12 months since onset;
- who can understand and follow instructions;
- who have ≥21 scores in Korean version of Mini-Mental State Examination (MMSE-K);
- who have mild to moderate motor impairment according to the Fugl Meyer Assessment (FMA) scores
Key exclusion criteria (4 listed)
- patients who have any kinds of mental disorder and/or Alzheimer's disease;
- who have orthopedic and/or musculoskeletal injury;
- who have apraxia; and
- who have previous experiences of participating in investigations and/or mirror therapy.
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 |
|---|---|---|
| 360 Degrees virtual reality-based mirror therapyParticipants will receive mirror therapy using a virtual reality device (Pico G2 VR 4K, Pico, China). They will be asked to follow tasks that are played in HMD using their paralyzed hand. The video played using HMD will be video taped using 360 degree camera prior to the treatment. The 360MT will last 30 minutes/session, 3 sessions a week for 4 weeks. The tasks are finger flexion-extension, wrist flexion-extension and pronation-supination, and elbow flexion-extension for ten repetitions. | Procedure or surgery | 360 Degrees Virtual Reality-based Mirror Therapy Group |
| Traditional mirror therapyParticipants will receive mirror therapy using an acrylic mirror (40cm x 40cm x 3cm) that reflects unparalyzed side of them. They will be asked to perform tasks including finger flexion-extension, wrist flexion-extension and pronation-supination, and elbow flexion-extension for ten repetitions. They will be asked to follow the reflection on mirror using their paralyzed limb. The TMT will last 30 minutes/session, 3 sessions a week for 4 weeks. | Procedure or surgery | Traditional Mirror Therapy Group |
| Conventional Physical TherapyParticipants will receive conventional physical therapy including neurodevelopmental therapy, muscle strengthening exercises, and joint mobilization which will be provided 60 minutes per day, 5 sessions a week, for 4 weeks. The therapy will follow upper extremity rehabilitation protocol which consists of three phases of warm up, circuit, and cool down exercises | Procedure or surgery | 360 Degrees Virtual Reality-based Mirror Therapy Group, Conventional Physical Therapy Group, Traditional Mirror Therapy Group |
Primary outcome
Fugl-Meyer Assessment for upper extremity (FMA-UE)
Time frame: Changes from baseline after 4 weeks of intervention
The test is one of the most frequently used evaluation tools that quantitatively assesses recovery after stroke by measuring motor skills, balance ability, sensory function, and range of motion. The maximum total score for FMA-UE is 66 points, containing 18 items to evaluate shoulder, elbow, and forearm; 5 for the wrist; 7 for the hand; and 3 items for coordination.
2 secondary outcomes
Manual Function Test (MFT)
Time frame: Changes from baseline after 4 weeks of intervention
Box & Block Test (BBT)
Time frame: Changes from baseline after 4 weeks of intervention
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 6 May 2023.
- 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.
Sungbae Jo, PhD candidate principal investigator
Sahmyook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 360 Degrees virtual reality-based mirror therapy, Traditional mirror therapy and Conventional Physical Therapy in people with Stroke and Stroke Rehabilitation, run by Sahmyook University at 1 site in South Korea.
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 4 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 6 May 2023. 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 South Korea. 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?
Fugl-Meyer Assessment for upper extremity (FMA-UE) (time frame: Changes from baseline after 4 weeks of intervention). 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 6 May 2023.