Virtual Reality With Mirror Therapy on Upper Limb Function

NCT ID: NCT06728475

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2025-03-15

Brief Summary

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The goal of this clinical trial is to address the effect of (Virtual Reality) and (Mirror Therapy) together on upper limb function in hemiplegic Cerebral Palsy children , male or female ranged between 3 to 10 years of age

. The main question of the study is Are there any significant differences between the effects of virtual reality , mirror therapy and the combined effect of both techniques and on upper limb function in hemiplegic CP children?

Participants will be subdevided into three groups A , B ,C Group (A): will receive VR in addition to designed physical therapy program Group (B): will receive MT in addition to designed physical therapy program Group (C): will receive the compound effect of both techniques in addition to designed physical therapy program

Detailed Description

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The goal of this clinical trial is to address the effect of (Virtual Reality) and (Mirror Therapy) together on upper limb function in hemiplegic Cerebral Palsy children , male or female ranged between 3 to 10 years of age

. The main question of the study is Are there any significant differences between the effects of virtual reality (VR), mirror therapy (MR) and the combined effect of both techniques (VR) and (MR) on upper limb function in hemiplegic CP children?

Participants will be subdevided into three groups A , B ,C Group (A): will receive VR in addition to designed physical therapy program Group (B): will receive MT in addition to designed physical therapy program Group (C): will receive the compound effect of both techniques in addition to designed physical therapy program

Conditions

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Hemiplegic Cerebral Palsy

Keywords

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Hemiplagia Upper limb function Virtual reality Mirror therapy Xbox 360

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group (A) virtual reality group

this group will receive virtual reality intervention plus designed physical therapy program

Group Type ACTIVE_COMPARATOR

virtual reality

Intervention Type DEVICE

In Xbox, we will choose suitable games that aim to improve upper limb function like boxing, Darts, tennis, goalkeeping, basketball, disc throwing, balling, and volleyball.

The Kinect sensor has the advantage of auto adjustment of its camera according to the child's position and height that's to say the child can perform the game in sitting or standing according to their abilities.

They will receive 30 minutes of VR intervention in addition to the time required for the designed physical therapy program.

Group (B) mirror therapy group

this group will receive mirror therapy intervention plus designed physical therapy program

Group Type ACTIVE_COMPARATOR

mirror therapy

Intervention Type OTHER

Mirror Therapy A mirror of 30 × 20 inches was used for the MT, which was large enough to cover the entire affected limb while still allowing the reflection of the non-affected limb to be seen. The child was seated in a chair with the forearms resting on the table. In the mid-sagittal plane, the mirror box was positioned at an angle of 70° to 80° to the trunk. The affected limb was placed behind the mirror. The child was asked to perform the exercises bilaterally and symmetrically as much as possible. Even if the affected side did not move easily or fully, the child was advised to synchronize the motions with both hands and arms. The researcher constantly reminded the child to concentrate on the movement of the non-affected limb in front of the mirror, which helped to increase the mirror illusion

Group (C) the compound effect of virtual reality and mirror therapy group

this group will receive virtual reality intervention , mirror therapy intervention plus designed physical threrapy program

Group Type ACTIVE_COMPARATOR

virtual reality with mirror therapy

Intervention Type OTHER

group C will receive combined effect of both techniques (virtual reality and mirror therapy)

Interventions

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virtual reality

In Xbox, we will choose suitable games that aim to improve upper limb function like boxing, Darts, tennis, goalkeeping, basketball, disc throwing, balling, and volleyball.

The Kinect sensor has the advantage of auto adjustment of its camera according to the child's position and height that's to say the child can perform the game in sitting or standing according to their abilities.

They will receive 30 minutes of VR intervention in addition to the time required for the designed physical therapy program.

Intervention Type DEVICE

mirror therapy

Mirror Therapy A mirror of 30 × 20 inches was used for the MT, which was large enough to cover the entire affected limb while still allowing the reflection of the non-affected limb to be seen. The child was seated in a chair with the forearms resting on the table. In the mid-sagittal plane, the mirror box was positioned at an angle of 70° to 80° to the trunk. The affected limb was placed behind the mirror. The child was asked to perform the exercises bilaterally and symmetrically as much as possible. Even if the affected side did not move easily or fully, the child was advised to synchronize the motions with both hands and arms. The researcher constantly reminded the child to concentrate on the movement of the non-affected limb in front of the mirror, which helped to increase the mirror illusion

Intervention Type OTHER

virtual reality with mirror therapy

group C will receive combined effect of both techniques (virtual reality and mirror therapy)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children will be included in the study if they fulfil the following criteria:

1. A medical diagnosis of spastic hemiplegic CP made by pediatric neurologists.
2. Children with spasticity grades ranged from 1 to 1+ according to MAS.
3. Their age range from 4 to 10 years.
4. Children level 1 and level 2 in gross motor functional classification (GMFC 1\&2)

Exclusion Criteria

* Children will be excluded from the study if:

1. They had a permanent deformity (bony or soft tissue contractures).
2. Children having visual or auditory defects.
3. Children who can not understand verbal commands
4. Children who had Botox application to the upper extremity in the past 6 months or had undergone a previous surgical intervention to wrist and hand.
Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kafrelsheikh University

OTHER

Sponsor Role lead

Responsible Party

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Khalid Esmail Mohamed Mohamed

Effect Of Virtual Reality with Mirror Therapy on Upper Limb Functions in Children with Hemiplegic Cerebral Palsy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed B Ibrahim, Ass.Prof.

Role: STUDY_CHAIR

head of pediatric department in faculty of physical therapy Kafrelshiekh university

Osama A El-Agamy, Professor

Role: STUDY_DIRECTOR

Professor and head of department of pediatric department Faculty of medicine Kafrelshiekh university

Sara Y Abdel Elglil, Lecturer

Role: STUDY_DIRECTOR

Lecturer in pediatric department in faculty of physical therapy Kafrelshiekh University

Locations

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faculty of physical therapy Kafrelshiekh university

Kafr ash Shaykh, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Khalid E Mohamed, Demonstrator

Role: CONTACT

Phone: +201120190879

Email: [email protected]

Facility Contacts

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khalid E mohamed, demonstrator

Role: primary

References

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Atasavun Uysal S, Baltaci G. Effects of Nintendo Wii Training on Occupational Performance, Balance, and Daily Living Activities in Children with Spastic Hemiplegic Cerebral Palsy: A Single-Blind and Randomized Trial. Games Health J. 2016 Oct;5(5):311-317. doi: 10.1089/g4h.2015.0102. Epub 2016 Oct 5.

Reference Type BACKGROUND
PMID: 27705006 (View on PubMed)

Other Identifiers

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KFSIRB200-254

Identifier Type: -

Identifier Source: org_study_id