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Comparison of Effectiveness of Virtual Reality With Mirror Therapy in Improving Motor Function of Upper Limb of Stroke Patients

Primary Purpose

Stroke

Status

Recruiting

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Oculus Quest 2

Mirror therapy box

About this trial

This is an interventional treatment trial for Stroke focused on measuring virtual reallity, Mirror therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Stroke affecting upper limb

Exclusion Criteria:

mental problem cognitive problem

Sites / Locations

Shifa tameer e millat universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Fugl- Meyer Upper extremity scale

Used to assess motor function of upper limb

Action arm research test

To check motor activity of upper limb

Wolf motor function

To identify motor activity of upper limb

Secondary Outcome Measures

Full Information

NCT ID

NCT05441228

First Posted

June 27, 2022

Last Updated

June 27, 2022

Sponsor

Shifa Tameer-e-Millat University

1. Study Identification

Unique Protocol Identification Number

NCT05441228

Brief Title

Comparison of Effectiveness of Virtual Reality With Mirror Therapy in Improving Motor Function of Upper Limb of Stroke Patients

Official Title

Comparison of Effectiveness of Virtual Reality With Mirror Therapy in Improving Motor Function of Upper Limb of Stroke Patients

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 4, 2022 (Actual)

Primary Completion Date

July 20, 2022 (Anticipated)

Study Completion Date

July 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shifa Tameer-e-Millat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

virtual reallity, Mirror therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Arm Title

Group B

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Oculus Quest 2

Intervention Description

Oculus Quest 2 is virtual reality headset with 2 hand control remotes. Beat Saber application will be used on Oculus Quest 2.

Intervention Type

Device

Intervention Name(s)

Mirror therapy box

Intervention Description

Mirror therapy is provided by mirror therapy box by placing it in sagittal plane of patient.

Primary Outcome Measure Information:

Title

Fugl- Meyer Upper extremity scale

Description

Used to assess motor function of upper limb

Time Frame

4 weeks

Title

Action arm research test

Description

To check motor activity of upper limb

Time Frame

4 weeks

Title

Wolf motor function

Description

To identify motor activity of upper limb

Time Frame

4 weeks

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Stroke affecting upper limb Exclusion Criteria: mental problem cognitive problem

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shafaq Altaf, Phd*

Phone

03435020507

shafaq_dpt.ahs@stmu.edu.pk

First Name & Middle Initial & Last Name or Official Title & Degree

Nouman Khan, MS-OMPT

Phone

03339378324

nouman_drs.ahs@stmu.edu.pk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Saleha Qamar, MSPT*

Organizational Affiliation

Students

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shifa tameer e millat university

City

Islamabad

State/Province

Federal

ZIP/Postal Code

44000

Country

Pakistan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shafaq Altaf, Phd*

Phone

03435020507

shafaq_dpt.ahs@stmu.edu.pk

First Name & Middle Initial & Last Name & Degree

Nouman Khan, Ms- OMPT

Phone

03339378324

nouman_drs.ahs@stmu.edu.pk

First Name & Middle Initial & Last Name & Degree

Saleha Qamar, DPT

12. IPD Sharing Statement

Citations:

PubMed Identifier

29156493

Citation

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.

Results Reference

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PubMed Identifier

33228710

Citation

Erhardsson 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.

Results Reference

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PubMed Identifier

23390640

Citation

Thieme 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.

Results Reference

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PubMed Identifier

31520506

Citation

Dahms 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.

Results Reference

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PubMed Identifier

24681826

Citation

Lohse 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.

Results Reference

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Comparison of Effectiveness of Virtual Reality With Mirror Therapy in Improving Motor Function of Upper Limb of Stroke Patients

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