Hemiplegic Cerebral PalsyNCT07401108
Reactive Balance Training vs Virtual Reality in Hemiplegic Cerebral Palsy
A study testing Virtual reality and Reactive Balance Training in people with Hemiplegic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
This randomized controlled study compared the effects of Wii Balance Board training versus reactive balance training on balance control and functional abilities in children with spastic hemiplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- Virtual reality and Reactive Balance Training
- 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
- 24 May 2025to 15 May 2026
- 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hemiplegic children between 6-10 years old.
- Both genders will be included.
- Their motor function will be between level I and II according to Gross Motor Function Classification System (GMFCS) .
- The degree of spasticity for these children will range from grade 1 to 1+ according to the Modified Ashworth Scale .
- They will be able to follow instructions during evaluation and treatment procedures
Who cannot join
- Cardiovascular or respiratory disorders.
- Undergone musculoskeletal surgery or botulinum toxin injection in the lower limbs in past six months
- Musculoskeletal problems or fixed deformities in the spine and/or lower extremities
- unstable seizures
- Visual or hearing impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reactive Balance Training Versus Virtual Reality on Balance and Functional Abilities in Children With Hemiplegia
This randomized controlled study compared the effects of Wii Balance Board training versus reactive balance training on balance control and functional abilities in children with spastic hemiplegic cerebral palsy. Sixty children aged 6-10 years (GMFCS levels I-II, mild spasticity) were randomly assigned to either a Wii-based balance training group or a reactive balance training group. Both groups received a conventional physical therapy program three times per week for eight weeks, with an additional 30 minutes of the assigned balance intervention per session. Balance and functional abilities were assessed before and after treatment using the HUMAC Balance System, Pediatric Balance Scale, Functional Reach Test, and Timed Up and Down Stairs test. The study aimed to evaluate and compare the effectiveness of both interventions in improving balance control and functional performance in this population.
Read the detailed description
This study was conducted as a randomized controlled trial to investigate and compare the effects of Wii Balance Board-based virtual reality training and reactive balance training on balance control and functional abilities in children with spastic hemiplegic cerebral palsy.
Study Design and Participants
Sixty children with spastic hemiplegia of both genders were recruited from Wahet Nour Elhayah Centers. Participants were aged between 6 and 10 years, classified as GMFCS levels I and II, and demonstrated mild spasticity (grades 1-1+ on the Modified Ashworth Scale). All children were able to follow verbal instructions and participate actively in assessment and treatment procedures. Children with musculoskeletal deformities, recent orthopedic surgery or botulinum toxin injections, uncontrolled seizures, cardiovascular or respiratory disorders, or visual or hearing impairments were excluded.
Participants were randomly allocated into two equal groups (Group A and Group B) using a simple randomization method.
Intervention Program
Both groups received a conventional physical therapy program for 90 minutes per session, three times per week for eight weeks. This program included neurodevelopmental treatment techniques, stretching exercises for affected upper and lower limbs, upper limb strengthening and functional exercises, and gait training.
In addition to conventional therapy, each group received a specific balance training intervention for 30 minutes per session.
Group A: Wii Balance Board Training (Virtual Reality-Based Balance Training)
Children in Group A participated in a structured balance training program using the Nintendo Wii Balance Board. Training was conducted three times per week for eight weeks. The program was designed to improve static and dynamic balance, weight-shifting ability, and sensorimotor integration through interactive virtual reality games.
During the first two weeks, training focused on familiarization with the device and games, with close therapist supervision, manual assistance, and verbal cues to ensure proper movement execution and safety. As participants progressed, manual assistance was gradually withdrawn, and training during the remaining weeks relied primarily on verbal instructions.
Each session was divided into three series. The first and second series included games such as Snowboard, Penguin Slide, and Super Hula Hoop, which required continuous weight shifting in the anteroposterior, mediolateral, and combined directions. Short rest periods (1-2 minutes) were provided between series to prevent fatigue. The third series involved relaxation and postural control exercises using the Yoga game, initially performed with eyes open and later with eyes closed to challenge sensory integration.
This training approach emphasized continuous visual feedback, motivation, and active participation, aiming to enhance postural control through multisensory stimulation and task-oriented practice.
Group B: Reactive Balance Training
Children in Group B received a structured reactive balance training program, also delivered three times per week for eight weeks, with each session lasting approximately 30 minutes. The goal of this intervention was to improve the child's ability to recover balance in response to unexpected perturbations.
Training included external perturbations, internal perturbations, and combinations of both. External perturbations were applied by the therapist through techniques such as lean-and-release maneuvers and sudden, unpredictable pushes to the shoulder or pelvis while the child stood on a stable or unstable surface. Children were instructed to maintain balance with minimal displacement of the center of gravity. Internal perturbations involved voluntary destabilizing tasks such as kicking or throwing a ball while maintaining postural stability.
As participants' reactive balance responses improved, task difficulty was progressively increased by modifying perturbation magnitude, direction, and unpredictability, as well as by introducing sensory challenges or unstable support surfaces. This progression aimed to simulate real-life balance disturbances and enhance rapid postural responses.
Outcome Measures and Assessment Procedures
All participants were evaluated before and after the 8-week intervention period. Balance was objectively assessed using the HUMAC Balance System, including measures of center of pressure, limits of stability, and weight-shifting ability. Functional balance was assessed using the Pediatric Balance Scale. Functional performance was evaluated using the Functional Reach Test and the Timed Up and Down Stairs (TUDS) test.
Purpose of the Protocol
This protocol was designed to determine the effectiveness of Wii-based virtual reality training and reactive balance training in improving balance control and functional abilities in children with spastic hemiplegia, and to compare which approach yields superior clinical outcomes. The results are intended to guide evidence-based balance rehabilitation strategies for this population.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- Virtual reality, Reactive Balance Training
- Keywords
- Virtual Reality, Hemiplegic Cerebral Palsy, Wii Balance Board, Reactive Balance Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
Also called Wii Balance Board
Participants will undergo a structured balance training program utilizing the Wii Balance Board. The program will consist of three training sessions per week over an eight-week period.
The first two weeks will focus on guided exercises with manual assistance and verbal instructions, ensuring that the children are comfortable and correctly performing the exercises. As the participants progress, the manual guidance will be gradually reduced, and verbal instructions alone will be provided for the remaining four weeks of training.
Reactive Balance TrainingOther
Also called Perturbation- Based Training
In reactive balance training, each session will include 3-4 of the following five core exercises: lean and release, push/pull, reaching with unexpected perturbation, weight shifting on unstable surfaces, and trip/slip simulation. Exercises will be divided into 2-3 blocks, with 6-8 perturbations in each block and short rest periods between blocks (1-2 min), for a total of 30-40 perturbations per session.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality using Wii Balance Board | Experimental | The Wii Balance Board is a non-immersive virtual reality (VR) rehabilitation tool that has been widely used in physical therapy to assess and train balance and postural control. It is a force-platform-based device equipped with four pressure sensors (anterior-posterior and medial-lateral) that detect changes in body weight distribution and shifts in the center of pressure (CoP). These data are transmitted in real time to the Nintendo Wii console, where body movements are translated into visual feedback displayed on a screen, allowing users to interact with virtual environments and game-based tasks. Receives: Device: Virtual reality |
| Reactive Balance training | Experimental | Participants will undergo structured reactive balance training that will consist of three sessions per week over an eight-week period. In Reactive balance training we will use different types of perturbations: External perturbations, Internal perturbation and combination of them. Training will last about 30 minutes. Receives: Other: Reactive Balance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limits of stability scores
The Humac Balance System will be used for assessment of balance through limits of stability (LOS) scores. Higher scores indicate better dynamic balance control
Measured: From enrollment to the end of treatment at 8 weeks
center of pressure scores
The Humac Balance System will be used for assessment of balance through center of pressure (COP) scores. Lower values indicate better posture control
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (2)
Functional reach test scores
Functional abilities will be assessed using the functional reach test measured in centimeters. Higher reach distance indicates better functional balance
Measured: From enrollment to the end of treatment at 8 weeks
Timed up-and-down-stairs test scores
Functional abilities will be assessed using timed up and down stairs measured in seconds. Lower time indicates better functional performance
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start24 May 2025
- Primary completion23 Feb 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Abd Elaziz Anter, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401108
- Sponsor's protocol ID
- P.T.REC/012/005531
- Status last verified
- Feb 2026
- First submitted
- 5 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reactive Balance Training Versus Virtual Reality on Balance and Functional Abilities in Children With Hemiplegia
- ClinicalTrials.gov ID
- NCT07401108
- Acronym / sponsor ID
- P.T.REC/012/005531
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- Virtual Reality, Hemiplegic Cerebral Palsy, Wii Balance Board, Reactive Balance Training
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 24 May 2025 (actual)
- Primary completion
- 23 Feb 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 10 Feb 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.
This randomized controlled study compared the effects of Wii Balance Board training versus reactive balance training on balance control and functional abilities in children with spastic hemiplegic cerebral palsy. Sixty children aged 6-10 years (GMFCS levels I-II, mild spasticity) were randomly assigned to either a Wii-based balance training group or a reactive balance training group. Both groups received a conventional physical therapy program three times per week for eight weeks, with an additional 30 minutes of the assigned balance intervention per session. Balance and functional abilities were assessed before and after treatment using the HUMAC Balance System, Pediatric Balance Scale, Functional Reach Test, and Timed Up and Down Stairs test. The study aimed to evaluate and compare the effectiveness of both interventions in improving balance control and functional performance in this population.
Detailed description
This study was conducted as a randomized controlled trial to investigate and compare the effects of Wii Balance Board-based virtual reality training and reactive balance training on balance control and functional abilities in children with spastic hemiplegic cerebral palsy.
Study Design and Participants
Sixty children with spastic hemiplegia of both genders were recruited from Wahet Nour Elhayah Centers. Participants were aged between 6 and 10 years, classified as GMFCS levels I and II, and demonstrated mild spasticity (grades 1-1+ on the Modified Ashworth Scale). All children were able to follow verbal instructions and participate actively in assessment and treatment procedures. Children with musculoskeletal deformities, recent orthopedic surgery or botulinum toxin injections, uncontrolled seizures, cardiovascular or respiratory disorders, or visual or hearing impairments were excluded.
Participants were randomly allocated into two equal groups (Group A and Group B) using a simple randomization method.
Intervention Program
Both groups received a conventional physical therapy program for 90 minutes per session, three times per week for eight weeks. This program included neurodevelopmental treatment techniques, stretching exercises for affected upper and lower limbs, upper limb strengthening and functional exercises, and gait training.
In addition to conventional therapy, each group received a specific balance training intervention for 30 minutes per session.
Group A: Wii Balance Board Training (Virtual Reality-Based Balance Training)
Children in Group A participated in a structured balance training program using the Nintendo Wii Balance Board. Training was conducted three times per week for eight weeks. The program was designed to improve static and dynamic balance, weight-shifting ability, and sensorimotor integration through interactive virtual reality games.
During the first two weeks, training focused on familiarization with the device and games, with close therapist supervision, manual assistance, and verbal cues to ensure proper movement execution and safety. As participants progressed, manual assistance was gradually withdrawn, and training during the remaining weeks relied primarily on verbal instructions.
Each session was divided into three series. The first and second series included games such as Snowboard, Penguin Slide, and Super Hula Hoop, which required continuous weight shifting in the anteroposterior, mediolateral, and combined directions. Short rest periods (1-2 minutes) were provided between series to prevent fatigue. The third series involved relaxation and postural control exercises using the Yoga game, initially performed with eyes open and later with eyes closed to challenge sensory integration.
This training approach emphasized continuous visual feedback, motivation, and active participation, aiming to enhance postural control through multisensory stimulation and task-oriented practice.
Group B: Reactive Balance Training
Children in Group B received a structured reactive balance training program, also delivered three times per week for eight weeks, with each session lasting approximately 30 minutes. The goal of this intervention was to improve the child's ability to recover balance in response to unexpected perturbations.
Training included external perturbations, internal perturbations, and combinations of both. External perturbations were applied by the therapist through techniques such as lean-and-release maneuvers and sudden, unpredictable pushes to the shoulder or pelvis while the child stood on a stable or unstable surface. Children were instructed to maintain balance with minimal displacement of the center of gravity. Internal perturbations involved voluntary destabilizing tasks such as kicking or throwing a ball while maintaining postural stability.
As participants' reactive balance responses improved, task difficulty was progressively increased by modifying perturbation magnitude, direction, and unpredictability, as well as by introducing sensory challenges or unstable support surfaces. This progression aimed to simulate real-life balance disturbances and enhance rapid postural responses.
Outcome Measures and Assessment Procedures
All participants were evaluated before and after the 8-week intervention period. Balance was objectively assessed using the HUMAC Balance System, including measures of center of pressure, limits of stability, and weight-shifting ability. Functional balance was assessed using the Pediatric Balance Scale. Functional performance was evaluated using the Functional Reach Test and the Timed Up and Down Stairs (TUDS) test.
Purpose of the Protocol
This protocol was designed to determine the effectiveness of Wii-based virtual reality training and reactive balance training in improving balance control and functional abilities in children with spastic hemiplegia, and to compare which approach yields superior clinical outcomes. The results are intended to guide evidence-based balance rehabilitation strategies for this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality using Wii Balance Board | Experimental | Device: Virtual realityThe Wii Balance Board is a non-immersive virtual reality (VR) rehabilitation tool that has been widely used in physical therapy to assess and train balance and postural control. It is a force-platform-based device equipped with four pressure sensors (anterior-posterior and medial-lateral) that detect changes in body weight distribution and shifts in the center of pressure (CoP). These data are transmitted in real time to the Nintendo Wii console, where body movements are translated into visual feedback displayed on a screen, allowing users to interact with virtual environments and game-based tasks. |
| Reactive Balance training | Experimental | Other: Reactive Balance TrainingParticipants will undergo structured reactive balance training that will consist of three sessions per week over an eight-week period. In Reactive balance training we will use different types of perturbations: External perturbations, Internal perturbation and combination of them. Training will last about 30 minutes. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Hemiplegic children between 6-10 years old.
- Both genders will be included.
- Their motor function will be between level I and II according to Gross Motor Function Classification System (GMFCS) .
- The degree of spasticity for these children will range from grade 1 to 1+ according to the Modified Ashworth Scale .
- They will be able to follow instructions during evaluation and treatment procedures
Key exclusion criteria (5 listed)
- Cardiovascular or respiratory disorders.
- Undergone musculoskeletal surgery or botulinum toxin injection in the lower limbs in past six months
- Musculoskeletal problems or fixed deformities in the spine and/or lower extremities
- unstable seizures
- Visual or hearing impairment
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 realityAlso: Wii Balance BoardParticipants will undergo a structured balance training program utilizing the Wii Balance Board. The program will consist of three training sessions per week over an eight-week period. The first two weeks will focus on guided exercises with manual assistance and verbal instructions, ensuring that the children are comfortable and correctly performing the exercises. As the participants progress, the manual guidance will be gradually reduced, and verbal instructions alone will be provided for the remaining four weeks of training. | Device | Virtual reality using Wii Balance Board |
| Reactive Balance TrainingAlso: Perturbation- Based TrainingIn reactive balance training, each session will include 3-4 of the following five core exercises: lean and release, push/pull, reaching with unexpected perturbation, weight shifting on unstable surfaces, and trip/slip simulation. Exercises will be divided into 2-3 blocks, with 6-8 perturbations in each block and short rest periods between blocks (1-2 min), for a total of 30-40 perturbations per session. | Other | Reactive Balance training |
Primary outcome
Limits of stability scores
Time frame: From enrollment to the end of treatment at 8 weeks
The Humac Balance System will be used for assessment of balance through limits of stability (LOS) scores. Higher scores indicate better dynamic balance control
center of pressure scores
Time frame: From enrollment to the end of treatment at 8 weeks
The Humac Balance System will be used for assessment of balance through center of pressure (COP) scores. Lower values indicate better posture control
2 secondary outcomes
Functional reach test scores
Time frame: From enrollment to the end of treatment at 8 weeks
Timed up-and-down-stairs test scores
Time frame: From enrollment to the end of treatment at 8 weeks
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 10 Feb 2026.
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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 and Reactive Balance Training in people with Hemiplegic Cerebral Palsy, run by Cairo 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: under way, not looking for participants, as of the sponsor's last update on 10 Feb 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?
Limits of stability scores (time frame: From enrollment to the end of treatment at 8 weeks). 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 10 Feb 2026.