Hemiplegic Cerebral PalsyNCT06728475
Virtual Reality With Mirror Therapy on Upper Limb Function
A study testing virtual reality, mirror therapy and virtual reality with mirror therapy in people with Hemiplegic Cerebral Palsy, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- virtual reality, mirror therapy and virtual reality with mirror therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2024to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children will be included in the study if they fulfil the following criteria:
- A medical diagnosis of spastic hemiplegic CP made by pediatric neurologists.
- Children with spasticity grades ranged from 1 to 1+ according to MAS.
- Their age range from 4 to 10 years.
- Children level 1 and level 2 in gross motor functional classification (GMFC 1\&2)
Who cannot join
- Children will be excluded from the study if:
- They had a permanent deformity (bony or soft tissue contractures).
- Children having visual or auditory defects.
- Children who can not understand verbal commands
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
faculty of physical therapy Kafrelshiekh university
Kafr ash Shaykh
khalid E mohamed, demonstrator, +201120190879, khalid.esmail@acu.edu.eg
About this study
Official title: Effect Of Virtual Reality With Mirror Therapy on Upper Limb Functions in Children With Hemiplegic Cerebral Palsy
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
Read the detailed description
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
- Hemiplegic Cerebral Palsy
- Being tested
- virtual reality, mirror therapy, virtual reality with mirror therapy
- Keywords
- Hemiplagia, Upper limb function, Virtual reality, Mirror therapy, Xbox 360
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityDevice
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.
mirror therapyOther
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
virtual reality with mirror therapyOther
group C will receive combined effect of both techniques (virtual reality and mirror therapy)
| Study group | Role | What they receive |
|---|---|---|
| Group (A) virtual reality group | Active comparator | this group will receive virtual reality intervention plus designed physical therapy program Receives: Device: virtual reality |
| Group (B) mirror therapy group | Active comparator | this group will receive mirror therapy intervention plus designed physical therapy program Receives: Other: mirror therapy |
| Group (C) the compound effect of virtual reality and mirror therapy group | Active comparator | this group will receive virtual reality intervention , mirror therapy intervention plus designed physical threrapy program Receives: Other: virtual reality with mirror therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in upper limb functions
using quality of upper extremity skills test (Quest)
Measured: after 12 weeks of intervention
changes in power grip strength
using sphygmomanometer
Measured: after 12 weeks of intervention
changes in range of motion (ROM)
using kinovea software
Measured: after 12 weeks of intervention
Secondary outcomes (1)
changes in activity of daily living (ADL)
using functional independence measure for children (WeeFIM):
Measured: after 12 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 posted11 Dec 2024
- Study start10 Dec 2024 (estimated)
- Primary completion10 Mar 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemiplegic Cerebral PalsyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khalid Esmail Mohamed Mohamed, Kafrelsheikh University
- Investigators
- Mohamed B Ibrahim, Ass.Prof., Study chair, head of pediatric department in faculty of physical therapy Kafrelshiekh universityOsama A El-Agamy, Professor, Study director, Professor and head of department of pediatric department Faculty of medicine Kafrelshiekh universitySara Y Abdel Elglil, Lecturer, Study director, Lecturer in pediatric department in faculty of physical therapy Kafrelshiekh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728475
- Sponsor's protocol ID
- KFSIRB200-254
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27705006
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Virtual Reality With Mirror Therapy on Upper Limb Functions in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06728475
- Acronym / sponsor ID
- KFSIRB200-254
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- Hemiplagia, Upper limb function, Virtual reality, Mirror therapy, Xbox 360
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 10 Dec 2024 (estimated)
- Primary completion
- 10 Mar 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 11 Dec 2024 (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 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
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (A) virtual reality group | Active comparator | Device: virtual realitythis group will receive virtual reality intervention plus designed physical therapy program |
| Group (B) mirror therapy group | Active comparator | Other: mirror therapythis group will receive mirror therapy intervention plus designed physical therapy program |
| Group (C) the compound effect of virtual reality and mirror therapy group | Active comparator | Other: virtual reality with mirror therapythis group will receive virtual reality intervention , mirror therapy intervention plus designed physical threrapy program |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children will be included in the study if they fulfil the following criteria:
Key exclusion criteria (5 listed)
- Children will be excluded from the study if:
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 |
|---|---|---|
| virtual realityIn 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. | Device | Group (A) virtual reality group |
| mirror therapyMirror 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 | Other | Group (B) mirror therapy group |
| virtual reality with mirror therapygroup C will receive combined effect of both techniques (virtual reality and mirror therapy) | Other | Group (C) the compound effect of virtual reality and mirror therapy group |
Primary outcome
changes in upper limb functions
Time frame: after 12 weeks of intervention
using quality of upper extremity skills test (Quest)
changes in power grip strength
Time frame: after 12 weeks of intervention
using sphygmomanometer
changes in range of motion (ROM)
Time frame: after 12 weeks of intervention
using kinovea software
1 secondary outcome
changes in activity of daily living (ADL)
Time frame: after 12 weeks of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Background: PubMed 27705006Atasavun 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.
- 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.
Mohamed B Ibrahim, Ass.Prof. study chair
head of pediatric department in faculty of physical therapy Kafrelshiekh university
Osama A El-Agamy, Professor study director
Professor and head of department of pediatric department Faculty of medicine Kafrelshiekh university
Sara Y Abdel Elglil, Lecturer study director
Lecturer in pediatric department in faculty of physical therapy Kafrelshiekh 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 virtual reality, mirror therapy and virtual reality with mirror therapy in people with Hemiplegic Cerebral Palsy, run by Kafrelsheikh University at 1 site in Egypt.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 11 Dec 2024. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khalid E Mohamed, Demonstrator (+201120190879, khalid.esmail@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in upper limb functions (time frame: after 12 weeks of intervention). 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 NCT06728475, which also lists 1 linked publication.
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 11 Dec 2024.