RehabilitationNCT05331703
Virtual Reality Versus Mirror Therapy on Balance and Muscle Strength in Children With Hemiplegic Cerebral Palsy
A study testing designed physical therapy program in addition to program of virtual reality. and designed physical therapy program in addition to program of mirror therapy. in people with Rehabilitation, run by October 6 University at 1 site in Egypt.
Trial summary
Previous research has demonstrated balance deficits ranging from 28%-43% depending on the nature of the balance task in individuals with CP compared to controls (Kenis-Coskun et al., 2016). Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Rehabilitation
- What is being tested?
- designed physical therapy program in addition to program of virtual reality. and designed physical therapy program in addition to program of mirror therapy.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Dec 2022to 22 Dec 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Their ages will range from 6 to 10 years old.
- The degree of spasticity will range from 1+ to 2 grades according to Modified Ashworth scale (NUMANO and Günel, 2011) (Appendix II).
- They will be on level I and II on Gross Motor Function Classification System (GMFCS) (Palisano et al., 2008) (Appendix III).
- Their heights will be one meter or more.
- They will be able to follow the verbal commands or instructions.
Who cannot join
- Severe visual or auditory problems.
- Epilepsy.
- History of surgical interference in lower limbs.
- Botulinum toxin injections of the lower limbs during the previous six
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Emad Eldin
Cairo, October, 8124
emad mohamed, phd, 01146808839, omdamohamed9111@gmail.com
About this study
Previous research has demonstrated balance deficits ranging from 28%-43% depending on the nature of the balance task in individuals with CP compared to controls (Kenis-Coskun et al., 2016). As balance is critical for underlying normal movement, improvements in static and dynamic balance are important goals in rehabilitation for ambulatory children with CP (Saether et al., 2013).
Balance deficits are among the symptoms that having a more profound impact on motor function and quality of life inn with CP children (Lai et al., 2017). Poor balance reduces the ability to perform gait-related activities and increases the risk of falling, which, in turn, limits participation in daily activities, including sports and physical activities (Usuba et al., 2015).
- Conditions
- Rehabilitation
- Being tested
- designed physical therapy program in addition to program of virtual reality., designed physical therapy program in addition to program of mirror therapy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
designed physical therapy program in addition to program of virtual reality.Other
physical therapy program in addition to program of virtual reality.
designed physical therapy program in addition to program of mirror therapy.Other
physical therapy program in addition to program of mirror therapy.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | will receive a designed physical therapy program in addition to program of virtual reality Receives: Other: designed physical therapy program in addition to program of virtual reality. |
| group B | Experimental | will receive a designed physical therapy program in addition to program of mirror therapy. Receives: Other: designed physical therapy program in addition to program of mirror therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodex balance system
The Biodex balance System to measures postural stability under dynamic stress.
Measured: 3 months
Hand held dynamometer
The hand held dynamometry to measure muscle strength of non-disabled children
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start22 Dec 2022 (estimated)
- Primary completion22 Mar 2023 (estimated)
- Study completion22 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, samar salem, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331703
- Sponsor's protocol ID
- P.T.REC/012/0035A342
- Status last verified
- Apr 2022
- First submitted
- 28 Mar 2022
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Versus Mirror Therapy on Balance and Muscle Strength in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05331703
- Acronym / sponsor ID
- P.T.REC/012/0035A342
- Conditions
- Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 22 Dec 2022 (estimated)
- Primary completion
- 22 Mar 2023 (estimated)
- Study completion
- 22 Dec 2023 (estimated)
- First posted
- 18 Apr 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.
Previous research has demonstrated balance deficits ranging from 28%-43% depending on the nature of the balance task in individuals with CP compared to controls (Kenis-Coskun et al., 2016). As balance is critical for underlying normal movement, improvements in static and dynamic balance are important goals in rehabilitation for ambulatory children with CP (Saether et al., 2013).
Balance deficits are among the symptoms that having a more profound impact on motor function and quality of life inn with CP children (Lai et al., 2017). Poor balance reduces the ability to perform gait-related activities and increases the risk of falling, which, in turn, limits participation in daily activities, including sports and physical activities (Usuba et al., 2015).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Other: designed physical therapy program in addition to program of virtual reality.will receive a designed physical therapy program in addition to program of virtual reality |
| group B | Experimental | Other: designed physical therapy program in addition to program of mirror therapy.will receive a designed physical therapy program in addition to program of mirror therapy. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Their ages will range from 6 to 10 years old.
- The degree of spasticity will range from 1+ to 2 grades according to Modified Ashworth scale (NUMANO and Günel, 2011) (Appendix II).
- They will be on level I and II on Gross Motor Function Classification System (GMFCS) (Palisano et al., 2008) (Appendix III).
- Their heights will be one meter or more.
- They will be able to follow the verbal commands or instructions.
Key exclusion criteria (4 listed)
- Severe visual or auditory problems.
- Epilepsy.
- History of surgical interference in lower limbs.
- Botulinum toxin injections of the lower limbs during the previous six
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 |
|---|---|---|
| designed physical therapy program in addition to program of virtual reality.physical therapy program in addition to program of virtual reality. | Other | group A |
| designed physical therapy program in addition to program of mirror therapy.physical therapy program in addition to program of mirror therapy. | Other | group B |
Primary outcome
Biodex balance system
Time frame: 3 months
The Biodex balance System to measures postural stability under dynamic stress.
Hand held dynamometer
Time frame: 3 months
The hand held dynamometry to measure muscle strength of non-disabled children
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing designed physical therapy program in addition to program of virtual reality. and designed physical therapy program in addition to program of mirror therapy. in people with Rehabilitation, run by October 6 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 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: status not confirmed, as of the sponsor's last update on 18 Apr 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodex balance system (time frame: 3 months). The study lists 2 primary outcomes in all. 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 18 Apr 2022.