Children With Hemiplegic cpNCT07884552
Virtual Reality Vs Postural Control Training in Children With Cerebral Palsy
A study testing Virtual reality in people with Children With Hemiplegic cp, run by Amira Mahmoud Abdelkader Mohamed at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if there is difference between the effect of virtual reality and postural control training on balance and gait in children with hemiplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Children With Hemiplegic cp
- What is being tested?
- Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 1 Feb 2027
- 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 8 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- They are diagnosed with hemiplegic cerebral palsy.
- Their ages ranged from 8-10 years.
- Degree of spasticity according to Modified Ashworth Scale will be ranged from grade 1 and 1+.
- The levels of gross motor function will be between level I and II according to Growth Motor Functional Classification System (GMFCS) for all children.
- Children's height will be minimum one meter (lower limits of height needed by the Biodex Balance System).
- Children will be able to follow verbal commands.
Who cannot join
- Visual or auditory problems.
- Contractures of the lower limbs.
- Seizures or epilepsy.
- Children who received Botulinum toxin injections for the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality Versus Postural Control Training on Balance and Gait in Children With Hemiplegic Cerebral Palsy
The goal of this clinical trial is to learn if there is difference between the effect of virtual reality and postural control training on balance and gait in children with hemiplegic cerebral palsy. The main questions it aims to answer are:
- Whether there is an effect of Virtual reality training on balance and gait in children with hemiplegic cerebral palsy?
- Whether there is an effect of Biodex training as a method of postural control on balance and gait in children with hemiplegic cerebral palsy? Researchers will compare the effect of Virtual reality and Biodex as a method of postural control training on balance and gait in children with hemiplegic CP.
Read more
Participants will:
- Receive the intervention for 2 months.
- Visit the clinic 3 times per week for sessions
- Conditions
- Children With Hemiplegic cp
- Being tested
- Virtual reality, Postural control training
- Keywords
- Virtual reality, Postural control, Balance, Gait, Cerebral palsy, Children
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
Wii fit plus will be used for balance training, which consist of a wireless handheld pointing device, the detection of movement and acceleration being in three dimensions by a motion sensor attached to a television. The virtual image is seen on the television screen that mimics the participant's movements. These games encourage the interaction of participants to play repetitively (Lohse, et al.,2014).
Postural control trainingDevice
The Biodex Stability System (BSS), is a unique balance assessment and training device. It is designed to assess the neuromuscular control and to stimulate joint mechanoreceptors (Hsue et al.,2009). It measures the ability of the subject to control the platform's angle of tilt, which is noted as a stability index and has high acceptable reliability (Hinman, 2009). It consists of a movable balance platform that provides up to 20 degrees of surface tilt in a360-degree range of motion. the platform is free to move about the AP and ML axes simultaneously (Figure 8) (Akhbari et al., 2007).
| Study group | Role | What they receive |
|---|---|---|
| Group A: Virtual reality | Experimental | Not described Receives: Device: Virtual reality |
| Group B: Postural control training | Experimental | Not described Receives: Device: Postural control training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stance time in seconds
Measured: 2 months
Walking speed in meter er seconds
Measured: 2 months
Step length in centimeters
Measured: 2 months
Center of balance in percentage of weight shift
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Oct 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Children With Hemiplegic cpStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amira Mahmoud Abdelkader Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amira Mahmoud Abdelkader Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884552
- Sponsor's protocol ID
- P.T.REC/012/006024
- Status last verified
- Sep 2026
- First submitted
- 7 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morone G, Tramontano M, Iosa M, Shofany J, Iemma A, Musicco M, Paolucci S, Caltagirone C. The efficacy of balance training with video game-based therapy in subacute stroke patients: a randomized controlled trial. Biomed Res Int. 2014;2014:580861. doi: 10.1155/2014/580861. Epub 2014 May 5.
PubMed 24877116Juras G, Słomka K, Fredyk A, Sobota G, Bacik B. (2008). Evaluation of the limits of stability (LOS) balance test. J Hum Kinet.;19(1):39-52; doi:10.2478/v10078-008-0003-0.
Arnoni JLB, Pavao SL, Dos Santos Silva FP, Rocha NACF. Effects of virtual reality in body oscillation and motor performance of children with cerebral palsy: A preliminary randomized controlled clinical trial. Complement Ther Clin Pract. 2019 May;35:189-194. doi: 10.1016/j.ctcp.2019.02.014. Epub 2019 Feb 25.
PubMed 31003657Jessica Cheunga, Melissa Marona, Sandy Tatlaa,b and Tal Jarusa.(2013). Virtual reality as balance rehabilitation for children with brain injury: A case study. Technology and Disability 25 (2013) 207-219 207; DOI 10.3233/TAD-130383
Jelsma J, Pronk M, Ferguson G, Jelsma-Smit D. The effect of the Nintendo Wii Fit on balance control and gross motor function of children with spastic hemiplegic cerebral palsy. Dev Neurorehabil. 2013;16(1):27-37. doi: 10.3109/17518423.2012.711781. Epub 2012 Oct 3.
PubMed 23030836Hsue BJ, Miller F, Su FC. The dynamic balance of the children with cerebral palsy and typical developing during gait. Part I: Spatial relationship between COM and COP trajectories. Gait Posture. 2009 Apr;29(3):465-70. doi: 10.1016/j.gaitpost.2008.11.007. Epub 2008 Dec 25.
PubMed 19111469Hinman M. (2009): Factors affecting reliability of the Biodex Balance System: A summary of four studies. J Sport Rehabil; 9:240-252.
Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
PubMed 22588748Hatem Abdal-Mohsen Emara; Tarek Mohamed El-Gohary; Osama Ahmed Khaled. (2016). Using Biodex balance training system to improve postural control in spastic diplegic cerebral palsy children: A biomechanical perspective. International Journal of Therapies & Rehabilitation Research; 5 (5):220-226. https://doi.org/10.5455/ijtrr.000000210
Gracies JM. Pathophysiology of spastic paresis. I: Paresis and soft tissue changes. Muscle Nerve. 2005 May;31(5):535-51. doi: 10.1002/mus.20284.
PubMed 15714510Gage JR. Gait analysis. An essential tool in the treatment of cerebral palsy. Clin Orthop Relat Res. 1993 Mar;(288):126-34.
PubMed 8458125Gorter JW, Rosenbaum PL, Hanna SE, Palisano RJ, Bartlett DJ, Russell DJ, Walter SD, Raina P, Galuppi BE, Wood E. Limb distribution, motor impairment, and functional classification of cerebral palsy. Dev Med Child Neurol. 2004 Jul;46(7):461-7. doi: 10.1017/s0012162204000763.
PubMed 15230459Flynn S, Palma P, Bender A. (2006). Low-tech virtual reality improves function in individuals with central nervous system injury. Journal of Neurological Physical Therapy;30(4): p210-211; DOI: 10.1097/01.NPT.0000281304.16905.61
Fang Q, Ghanouni P, Anderson SE, Touchett H, Shirley R, Fang F, Fang C. Effects of Exergaming on Balance of Healthy Older Adults: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Games Health J. 2020 Feb;9(1):11-23. doi: 10.1089/g4h.2019.0016. Epub 2019 Dec 3.
PubMed 31800322Elnaggar RK. Effects of plyometric exercises on muscle-activation strategies and response-capacity to balance threats in children with hemiplegic cerebral palsy. Physiother Theory Pract. 2022 Sep;38(9):1165-1173. doi: 10.1080/09593985.2020.1833389. Epub 2020 Oct 12.
PubMed 33044886
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Versus Postural Control Training on Balance and Gait in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07884552
- Acronym / sponsor ID
- P.T.REC/012/006024
- Conditions
- Children With Hemiplegic cp
- Keywords
- Virtual reality, Postural control, Balance, Gait, Cerebral palsy, Children
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Amira Mahmoud Abdelkader MohamedUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 20 Oct 2026 (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 learn if there is difference between the effect of virtual reality and postural control training on balance and gait in children with hemiplegic cerebral palsy. The main questions it aims to answer are:
- Whether there is an effect of Virtual reality training on balance and gait in children with hemiplegic cerebral palsy?
- Whether there is an effect of Biodex training as a method of postural control on balance and gait in children with hemiplegic cerebral palsy? Researchers will compare the effect of Virtual reality and Biodex as a method of postural control training on balance and gait in children with hemiplegic CP.
Participants will:
- Receive the intervention for 2 months.
- Visit the clinic 3 times per week for sessions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Virtual reality | Experimental | Device: Virtual reality |
| Group B: Postural control training | Experimental | Device: Postural control training |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- They are diagnosed with hemiplegic cerebral palsy.
- Their ages ranged from 8-10 years.
- Degree of spasticity according to Modified Ashworth Scale will be ranged from grade 1 and 1+.
- The levels of gross motor function will be between level I and II according to Growth Motor Functional Classification System (GMFCS) for all children.
- Children's height will be minimum one meter (lower limits of height needed by the Biodex Balance System).
Key exclusion criteria (4 listed)
- Visual or auditory problems.
- Contractures of the lower limbs.
- Seizures or epilepsy.
- Children who received Botulinum toxin injections for the past 6 months.
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 realityWii fit plus will be used for balance training, which consist of a wireless handheld pointing device, the detection of movement and acceleration being in three dimensions by a motion sensor attached to a television. The virtual image is seen on the television screen that mimics the participant's movements. These games encourage the interaction of participants to play repetitively (Lohse, et al.,2014). | Device | Group A: Virtual reality |
| Postural control trainingThe Biodex Stability System (BSS), is a unique balance assessment and training device. It is designed to assess the neuromuscular control and to stimulate joint mechanoreceptors (Hsue et al.,2009). It measures the ability of the subject to control the platform's angle of tilt, which is noted as a stability index and has high acceptable reliability (Hinman, 2009). It consists of a movable balance platform that provides up to 20 degrees of surface tilt in a360-degree range of motion. the platform is free to move about the AP and ML axes simultaneously (Figure 8) (Akhbari et al., 2007). | Device | Group B: Postural control training |
Primary outcome
Stance time in seconds
Time frame: 2 months
Walking speed in meter er seconds
Time frame: 2 months
Step length in centimeters
Time frame: 2 months
Center of balance in percentage of weight shift
Time frame: 2 months
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 20 Oct 2026.
- Background: PubMed 24877116Morone G, Tramontano M, Iosa M, Shofany J, Iemma A, Musicco M, Paolucci S, Caltagirone C. The efficacy of balance training with video game-based therapy in subacute stroke patients: a randomized controlled trial. Biomed Res Int. 2014;2014:580861. doi: 10.1155/2014/580861. Epub 2014 May 5.
- BackgroundJuras G, Słomka K, Fredyk A, Sobota G, Bacik B. (2008). Evaluation of the limits of stability (LOS) balance test. J Hum Kinet.;19(1):39-52; doi:10.2478/v10078-008-0003-0.
- Background: PubMed 31003657Arnoni JLB, Pavao SL, Dos Santos Silva FP, Rocha NACF. Effects of virtual reality in body oscillation and motor performance of children with cerebral palsy: A preliminary randomized controlled clinical trial. Complement Ther Clin Pract. 2019 May;35:189-194. doi: 10.1016/j.ctcp.2019.02.014. Epub 2019 Feb 25.
- BackgroundJessica Cheunga, Melissa Marona, Sandy Tatlaa,b and Tal Jarusa.(2013). Virtual reality as balance rehabilitation for children with brain injury: A case study. Technology and Disability 25 (2013) 207-219 207; DOI 10.3233/TAD-130383
- Background: PubMed 23030836Jelsma J, Pronk M, Ferguson G, Jelsma-Smit D. The effect of the Nintendo Wii Fit on balance control and gross motor function of children with spastic hemiplegic cerebral palsy. Dev Neurorehabil. 2013;16(1):27-37. doi: 10.3109/17518423.2012.711781. Epub 2012 Oct 3.
- Background: PubMed 19111469Hsue BJ, Miller F, Su FC. The dynamic balance of the children with cerebral palsy and typical developing during gait. Part I: Spatial relationship between COM and COP trajectories. Gait Posture. 2009 Apr;29(3):465-70. doi: 10.1016/j.gaitpost.2008.11.007. Epub 2008 Dec 25.
- BackgroundHinman M. (2009): Factors affecting reliability of the Biodex Balance System: A summary of four studies. J Sport Rehabil; 9:240-252.
- Background: PubMed 22588748Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
- BackgroundHatem Abdal-Mohsen Emara; Tarek Mohamed El-Gohary; Osama Ahmed Khaled. (2016). Using Biodex balance training system to improve postural control in spastic diplegic cerebral palsy children: A biomechanical perspective. International Journal of Therapies & Rehabilitation Research; 5 (5):220-226. https://doi.org/10.5455/ijtrr.000000210
- Background: PubMed 15714510Gracies JM. Pathophysiology of spastic paresis. I: Paresis and soft tissue changes. Muscle Nerve. 2005 May;31(5):535-51. doi: 10.1002/mus.20284.
- Background: PubMed 8458125Gage JR. Gait analysis. An essential tool in the treatment of cerebral palsy. Clin Orthop Relat Res. 1993 Mar;(288):126-34.
- Background: PubMed 15230459Gorter JW, Rosenbaum PL, Hanna SE, Palisano RJ, Bartlett DJ, Russell DJ, Walter SD, Raina P, Galuppi BE, Wood E. Limb distribution, motor impairment, and functional classification of cerebral palsy. Dev Med Child Neurol. 2004 Jul;46(7):461-7. doi: 10.1017/s0012162204000763.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Children With Hemiplegic cp, run by Amira Mahmoud Abdelkader Mohamed 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 6 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stance time in seconds (time frame: 2 months). The study lists 4 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 NCT07884552, which also lists 33 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 20 Oct 2026.