StrokeNCT05441228
Comparison of Effectiveness of Virtual Reality With Mirror Therapy in Improving Motor Function of Upper Limb of Stroke Patients
A study testing Oculus Quest 2 and Mirror therapy box in people with Stroke, run by Shifa Tameer-e-Millat University at 1 site in Pakistan.
Trial summary
The purpose of the study is to compare the effectiveness of virtual reality and mirror therapy in stroke patients. Different studies has been done to find out the best therapy for stroke patients. Use of virtual reality in medical field is becoming more popular now-a-days. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Oculus Quest 2 and Mirror therapy box
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Apr 2022to 20 Jul 2022
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Stroke affecting upper limb
Who cannot join
- mental problem cognitive problem
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Shifa tameer e millat university
Islamabad, Federal, 44000
Shafaq Altaf, Phd*, 03435020507, shafaq_dpt.ahs@stmu.edu.pk
Nouman Khan, Ms- OMPT, 03339378324, nouman_drs.ahs@stmu.edu.pk
About this study
The purpose of the study is to compare the effectiveness of virtual reality and mirror therapy in stroke patients. Different studies has been done to find out the best therapy for stroke patients. Use of virtual reality in medical field is becoming more popular now-a-days. Different devices and applications are available to treat various conditions. Research has been done to find the clinical applications of virtual reality for upper limb motor rehabilitation in stroke. in another study, mirror therapy with bilateral arm training was used for hemiplegic upper extremity motor functions in patients with chronic stroke. After doing literature review, it was found that no research has been done to compare the effectiveness of mirror therapy with virtual reality in improving motor function of upper limb of stroke patients. So, In this study these two therapies are compared. For virtual reality Oculus Quest 2 has been used. Patients were allowed to use beat saber game on Oculus.
- Conditions
- Stroke
- Being tested
- Oculus Quest 2, Mirror therapy box
- Keywords
- virtual reallity, 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.
Oculus Quest 2Device
Oculus Quest 2 is virtual reality headset with 2 hand control remotes. Beat Saber application will be used on Oculus Quest 2.
Mirror therapy boxDevice
Mirror therapy is provided by mirror therapy box by placing it in sagittal plane of patient.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A receives virtual reality through Oculus Quest 2. Beat saber application will be used to improve upper limb's motor function of stroke patients. Total 1 hour session will be provided to each patient for 5 days a week. Total period 4 weeks Receives: Device: Oculus Quest 2 |
| Group B | Other | Group B receives mirror therapy through mirror therapy box. Total 1 hour session will be provided to each patient for 5 days a week. Total period 4 weeks Receives: Device: Mirror therapy box |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl- Meyer Upper extremity scale
Used to assess motor function of upper limb
Measured: 4 weeks
Action arm research test
To check motor activity of upper limb
Measured: 4 weeks
Wolf motor function
To identify motor activity of upper limb
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start4 Apr 2022
- Primary completion20 Jul 2022 (estimated)
- Study completion20 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Model description
- The participant are divided into two groups. The group a received virtual reality and group b received mirror therapy.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shifa Tameer-e-Millat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouman Khan, Shifa Tameer-e-Millat University
- Investigators
- Saleha Qamar, MSPT*, Principal investigator, Students
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441228
- Sponsor's protocol ID
- Saleha 279-21
- Status last verified
- Jun 2022
- First submitted
- 27 Jun 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4.
PubMed 29156493Erhardsson M, Alt Murphy M, Sunnerhagen KS. Commercial head-mounted display virtual reality for upper extremity rehabilitation in chronic stroke: a single-case design study. J Neuroeng Rehabil. 2020 Nov 23;17(1):154. doi: 10.1186/s12984-020-00788-x.
PubMed 33228710Thieme H, Mehrholz J, Pohl M, Behrens J, Dohle C. Mirror therapy for improving motor function after stroke. Stroke. 2013 Jan;44(1):e1-2. doi: 10.1161/strokeaha.112.673087.
PubMed 23390640Dahms C, Brodoehl S, Witte OW, Klingner CM. The importance of different learning stages for motor sequence learning after stroke. Hum Brain Mapp. 2020 Jan;41(1):270-286. doi: 10.1002/hbm.24793. Epub 2019 Sep 14.
PubMed 31520506Lohse KR, Hilderman CG, Cheung KL, Tatla S, Van der Loos HF. Virtual reality therapy for adults post-stroke: a systematic review and meta-analysis exploring virtual environments and commercial games in therapy. PLoS One. 2014 Mar 28;9(3):e93318. doi: 10.1371/journal.pone.0093318. eCollection 2014.
PubMed 24681826
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of Virtual Reality With Mirror Therapy in Improving Motor Function of Upper Limb of Stroke Patients
- ClinicalTrials.gov ID
- NCT05441228
- Acronym / sponsor ID
- Saleha 279-21
- Conditions
- Stroke
- Keywords
- virtual reallity, Mirror therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Shifa Tameer-e-Millat UniversityUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 20 Jul 2022 (estimated)
- Study completion
- 20 Jul 2022 (estimated)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the effectiveness of virtual reality and mirror therapy in stroke patients. Different studies has been done to find out the best therapy for stroke patients. Use of virtual reality in medical field is becoming more popular now-a-days. Different devices and applications are available to treat various conditions. Research has been done to find the clinical applications of virtual reality for upper limb motor rehabilitation in stroke. in another study, mirror therapy with bilateral arm training was used for hemiplegic upper extremity motor functions in patients with chronic stroke. After doing literature review, it was found that no research has been done to compare the effectiveness of mirror therapy with virtual reality in improving motor function of upper limb of stroke patients. So, In this study these two therapies are compared. For virtual reality Oculus Quest 2 has been used. Patients were allowed to use beat saber game on Oculus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participant are divided into two groups. The group a received virtual reality and group b received mirror therapy.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Oculus Quest 2Group A receives virtual reality through Oculus Quest 2. Beat saber application will be used to improve upper limb's motor function of stroke patients. Total 1 hour session will be provided to each patient for 5 days a week. Total period 4 weeks |
| Group B | Other | Device: Mirror therapy boxGroup B receives mirror therapy through mirror therapy box. Total 1 hour session will be provided to each patient for 5 days a week. Total period 4 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Stroke affecting upper limb
Key exclusion criteria (1 listed)
- mental problem cognitive problem
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 |
|---|---|---|
| Oculus Quest 2Oculus Quest 2 is virtual reality headset with 2 hand control remotes. Beat Saber application will be used on Oculus Quest 2. | Device | Group A |
| Mirror therapy boxMirror therapy is provided by mirror therapy box by placing it in sagittal plane of patient. | Device | Group B |
Primary outcome
Fugl- Meyer Upper extremity scale
Time frame: 4 weeks
Used to assess motor function of upper limb
Action arm research test
Time frame: 4 weeks
To check motor activity of upper limb
Wolf motor function
Time frame: 4 weeks
To identify motor activity of upper limb
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Background: PubMed 29156493Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4.
- Background: PubMed 33228710Erhardsson M, Alt Murphy M, Sunnerhagen KS. Commercial head-mounted display virtual reality for upper extremity rehabilitation in chronic stroke: a single-case design study. J Neuroeng Rehabil. 2020 Nov 23;17(1):154. doi: 10.1186/s12984-020-00788-x.
- Background: PubMed 23390640Thieme H, Mehrholz J, Pohl M, Behrens J, Dohle C. Mirror therapy for improving motor function after stroke. Stroke. 2013 Jan;44(1):e1-2. doi: 10.1161/strokeaha.112.673087.
- Background: PubMed 31520506Dahms C, Brodoehl S, Witte OW, Klingner CM. The importance of different learning stages for motor sequence learning after stroke. Hum Brain Mapp. 2020 Jan;41(1):270-286. doi: 10.1002/hbm.24793. Epub 2019 Sep 14.
- Background: PubMed 24681826Lohse KR, Hilderman CG, Cheung KL, Tatla S, Van der Loos HF. Virtual reality therapy for adults post-stroke: a systematic review and meta-analysis exploring virtual environments and commercial games in therapy. PLoS One. 2014 Mar 28;9(3):e93318. doi: 10.1371/journal.pone.0093318. eCollection 2014.
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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.
Saleha Qamar, MSPT* principal investigator
Students
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oculus Quest 2 and Mirror therapy box in people with Stroke, run by Shifa Tameer-e-Millat University at 1 site in Pakistan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Jul 2022. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shafaq Altaf, Phd* (03435020507, shafaq_dpt.ahs@stmu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl- Meyer Upper extremity scale (time frame: 4 weeks). The study lists 3 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 NCT05441228, which also lists 5 linked publications.
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 1 Jul 2022.