Hemiplegic Cerebral PalsyNCT07792278
Full-Immersive Virtual Reality for Lower Limb Strength and Balance in Children With Hemiplegic Cerebral Palsy
A study testing A selected physical therapy program and Fully Immersive Virtual Reality in people with Hemiplegic Cerebral Palsy, run by Adly A Adam at 1 site in Egypt.
Trial summary
Hemiplegic cerebral palsy (HCP) is a neurological disorder that affects one side of the body, resulting in muscle weakness and impaired balance. Virtual reality (VR) is a promising tool in pediatric rehabilitation due to its engaging and interactive nature. Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- A selected physical therapy program and Fully Immersive Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2024to 30 Jun 2026
- 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 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Their Ages ranged from 7to10 years chronologically.
- Both genders will be included.
- They are able to understand and follow simple verbal commands or instructions included in both assessment and training procedures.
- Their degree of spasticity will range from 1 to 1+ according to the Modified Ashworth Scale
- Their motor function will be at level I according to Gross Motor Function Classification System
Who cannot join
- Bony joint limitation or skeletal deformities in lower limb.
- Surgeries (Tenotomy or muscle transfer in the affected lower limb) at last 6 months before the study.
- Botox injection at last 6 months before the study.
- Visual or auditory abnormalities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Full-Immersive Virtual Reality for Lower Limb Strength and Balance in Children With Hemiplegic Cerebral Palsy: A Randomized Controlled Trial
Hemiplegic cerebral palsy (HCP) is a neurological disorder that affects one side of the body, resulting in muscle weakness and impaired balance. Virtual reality (VR) is a promising tool in pediatric rehabilitation due to its engaging and interactive nature. Aim: To investigate the effect of VR on lower-limb muscle strength and balance in children with HCP. Methods:30 children with HCP aged 7-10 years were randomly allocated to two equal groups. The control group received a selected physical therapy program, whereas the study group received the same program combined with fully immersive VR training. The total treatment period was 8 weeks. Lower-limb muscle strength was assessed using a Lafayette hand-held dynamometer. The Five Times Sit-to-Stand Test was used to assess functional lower-limb strength, and the Pediatric Balance Scale was used to assess balance.
Read the detailed description
Cerebral palsy (CP) comprises a group of disorders resulting from injury to the developing brain, affecting motor function and postural control. Hemiplegic cerebral palsy (HCP) predominantly impacts one side of the body, accounting for approximately 38% of all cases of CP. Weakness is more prominent in distal muscle groups, with the hip extensors, knee extensors, and ankle dorsiflexors demonstrating more weakness than their antagonistic muscle groups. Virtual reality (VR) has been implemented in the treatment of children having CP. VR rehabilitation facilitates training across various complexity levels, while providing feedback within a safe and controlled setting. VR allows therapists to regulate the duration and intensity of tasks that are not feasible in the actual world. This study aimed to investigate the effect of fully immersive VR as an adjunct to the rehabilitation program of children with HCP for improving the clinical outcomes of lower-limb strength and balance. G*POWER statistical software (version 3.1.9.2) was utilized with α=0.05, 80% power, and an allocation ratio of N2/N1 = 1. For this study, a minimum sample of 30 children, 15 in each group, was considered adequate, based on Modified Ashworth Scale Grade 1, 1+, and Gross Motor Function Classification System. The control group received a selected physical therapy program 60 minutes and were conducted three times weekly for 8 consecutive weeks. The study group received a similar program of the control group along with VR-based training for 20-30 minutes each, three times weekly, across 8-week duration. Lafayette hand-held dynamometer, Five repetition sit to stand test, and Pediatric Balance Scale was utilized for evaluation.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- A selected physical therapy program, Fully Immersive Virtual Reality
- Keywords
- Cerebral Palsy, Balance, Hemiplegic Cerebral Palsy, Virtual Reality
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A selected physical therapy programOther
A selected physical therapy program based on NDT principles according to for 60 minutes, 3 times/week for 6 successive weeks including the following exercises: strengthening exercises, stretching exercises, facilitation of postural reactions from standing position including: standing on one leg, weight shifting from standing position, stoop and recover from standing, squat from standing, standing on balance board and pushing the child in different directions and gait training activities for correction of gait pattern including: walking on balance beam, walking on balance board, walking on uneven surface, walking using different obstacles (rolls, wedges, stepper) and walking up and down stairs
Fully Immersive Virtual RealityOther
Children in the study group only were given the same selected program as the control group, along with VR training using two interactive VRapeutic therapeutic games. Viblio, and Garden Do modules were chosen for their focus on functional, engaging virtual tasks that require movement and balance. VR sessions were conducted for 20-30 minutes each, three times weekly, across 8-week duration. The equipment included VRapeutic immersive rehabilitation system (VRapeutic Inc.); Lenovo IdeaPad 110 laptop (Intel Core i5-6200U CPU, 16 GB RAM, AMD Radeon R5 M430 GPU) running the VRapeutic software (developed with Unity™ 2019.4.40f1 LTS), Oculus Quest 2 VR headset (head-mounted display with 1440×1600 resolution per eye and a 96°×94° field of view), and two Oculus Touch handheld controllers, LED screen (43") was also used to guide the session
| Study group | Role | What they receive |
|---|---|---|
| Control Group (A) | Active comparator | Children in both groups received a physical therapy program according to Neurodevelopmental Treatment (NDT) principles. Equipment included mats, rolls, therapy balls, weights, and balance boards. Sessions lasted 60 minutes and were conducted three times weekly for 8 consecutive weeks. The program addressing the following: 1) muscle strengthening exercises in the form of functional exercises such as straight-leg raises, heel slides, and bridging (hip lift) and sit-to-stand from a chair exercises to engage core and lower-limb muscles. 2) gentle stretching for tight muscle groups, particularly the hamstrings, calf muscles, and hip flexors, 3) Supported standing exercises, 4) Dynamic and static balance activities, 5) gait training including obstacle walking, high-knee walking, and dual-tasking. Receives: Other: A selected physical therapy program |
| Study Group (B) | Experimental | Children in the study group only were given the same selected program as the control group, along with VR training using two interactive VRapeutic therapeutic games. Viblio, and Garden Do modules were chosen for their focus on functional, engaging virtual tasks that require movement and balance. VR sessions were conducted for 20-30 minutes each, three times weekly, across 8-week duration. The equipment included VRapeutic immersive rehabilitation system (VRapeutic Inc.); Lenovo IdeaPad 110 laptop (Intel Core i5-6200U CPU, 16 GB RAM, AMD Radeon R5 M430 GPU) running the VRapeutic software (developed with Unity™ 2019.4.40f1 LTS), Oculus Quest 2 VR headset (head-mounted display with 1440×1600 resolution per eye and a 96°×94° field of view), and two Oculus Touch handheld controllers, LED screen (43") was also used to guide the session Receives: Other: A selected physical therapy program; Other: Fully Immersive Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lafayette hand-held dynamometer (HHD)
[Model: 01163, Lafayette Instrument Company, USA] was used for objective measurement of isometric muscle strength of the hip, knee muscle groups. The HHD was calibrated by the manufacturer before assessment. Hip flexors and knee extensors were assessed in a sitting position; hip abductors were assessed in a supine posture; and hip extensors and knee flexors were assessed in a prone position. The child was assessed in three distinct positions: supine, prone, and sitting. The child was asked to perform two warm-up trials at sub maximal effort without the transducer being placed on the limb. Transducer was subsequently placed on the limb, and the child performed three maximal attempts lasting 5 seconds each, with a 30-second rest interval between trials. The child was instructed and verbally prompted to exert maximal force during the test, while the examiner resisted the child's maximal voluntary contraction, representing the maximal isometric force. Peak isometric presented in Newtons.
Measured: 1. Pre-treatment at base-line of the study. 2. Post-treatment after 8 weeks of intervention.
Secondary outcomes (2)
Five-Repetition Sit-to-Stand Test (FTSST)
FTSST is a reliable evaluative test used to assess lower-limb functional strength and has demonstrated correlations with functional balance ability assessments among children with CP. Test tools include a height-adjustable chair without an arm rest and a stopwatch. A stopwatch was used to measure how long it takes to perform five successive sit-to-stand-to-sit cycles as fast as possible.
Measured: 1. Pre-treatment at base-line of the study. 2. Post-treatment after 8 weeks of intervention.
The Pediatric Balance Scale (PBS)
PBS was used to evaluate the participants' functional balance, which is a valid and reliable scale. The scale comprises the following equipment: height-adjustable bench, chair with lumbar support and armrests, stopwatch or watch with a second hand, one-inch-wide masking tape, step stool six inches in height, chalkboard eraser, ruler or yardstick, and small level. It consists of 14 items. Every item has a score between 0 and 4, where higher scores correspond to better balance.
Measured: 1. Pre-treatment at base-line of the study. 2. Post-treatment after 8 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 posted28 Aug 2026
- Study start10 May 2024
- Primary completion1 Mar 2026
- Study completion30 Jun 2026
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.
- 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
- Model description
- Random controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adly A Adam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adly A Adam, Cairo University
- Investigators
- Gehan H El-Meniawy, Professor, Study chair, Cairo University; Faculty of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792278
- Sponsor's protocol ID
- P.T.REC/012/005126
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full-Immersive Virtual Reality for Lower Limb Strength and Balance in Children With Hemiplegic Cerebral Palsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07792278
- Acronym / sponsor ID
- P.T.REC/012/005126
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- Cerebral Palsy, Balance, Hemiplegic Cerebral Palsy, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Adly A AdamUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 28 Aug 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.
Hemiplegic cerebral palsy (HCP) is a neurological disorder that affects one side of the body, resulting in muscle weakness and impaired balance. Virtual reality (VR) is a promising tool in pediatric rehabilitation due to its engaging and interactive nature. Aim: To investigate the effect of VR on lower-limb muscle strength and balance in children with HCP. Methods:30 children with HCP aged 7-10 years were randomly allocated to two equal groups. The control group received a selected physical therapy program, whereas the study group received the same program combined with fully immersive VR training. The total treatment period was 8 weeks. Lower-limb muscle strength was assessed using a Lafayette hand-held dynamometer. The Five Times Sit-to-Stand Test was used to assess functional lower-limb strength, and the Pediatric Balance Scale was used to assess balance.
Detailed description
Cerebral palsy (CP) comprises a group of disorders resulting from injury to the developing brain, affecting motor function and postural control. Hemiplegic cerebral palsy (HCP) predominantly impacts one side of the body, accounting for approximately 38% of all cases of CP. Weakness is more prominent in distal muscle groups, with the hip extensors, knee extensors, and ankle dorsiflexors demonstrating more weakness than their antagonistic muscle groups. Virtual reality (VR) has been implemented in the treatment of children having CP. VR rehabilitation facilitates training across various complexity levels, while providing feedback within a safe and controlled setting. VR allows therapists to regulate the duration and intensity of tasks that are not feasible in the actual world. This study aimed to investigate the effect of fully immersive VR as an adjunct to the rehabilitation program of children with HCP for improving the clinical outcomes of lower-limb strength and balance. G*POWER statistical software (version 3.1.9.2) was utilized with α=0.05, 80% power, and an allocation ratio of N2/N1 = 1. For this study, a minimum sample of 30 children, 15 in each group, was considered adequate, based on Modified Ashworth Scale Grade 1, 1+, and Gross Motor Function Classification System. The control group received a selected physical therapy program 60 minutes and were conducted three times weekly for 8 consecutive weeks. The study group received a similar program of the control group along with VR-based training for 20-30 minutes each, three times weekly, across 8-week duration. Lafayette hand-held dynamometer, Five repetition sit to stand test, and Pediatric Balance Scale was utilized for evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Random controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control Group (A) | Active comparator | Other: A selected physical therapy programChildren in both groups received a physical therapy program according to Neurodevelopmental Treatment (NDT) principles. Equipment included mats, rolls, therapy balls, weights, and balance boards. Sessions lasted 60 minutes and were conducted three times weekly for 8 consecutive weeks. The program addressing the following: 1) muscle strengthening exercises in the form of functional exercises such as straight-leg raises, heel slides, and bridging (hip lift) and sit-to-stand from a chair exercises to engage core and lower-limb muscles. 2) gentle stretching for tight muscle groups, particularly the hamstrings, calf muscles, and hip flexors, 3) Supported standing exercises, 4) Dynamic and static balance activities, 5) gait training including obstacle walking, high-knee walking, and dual-tasking. |
| Study Group (B) | Experimental | Other: A selected physical therapy program, Other: Fully Immersive Virtual RealityChildren in the study group only were given the same selected program as the control group, along with VR training using two interactive VRapeutic therapeutic games. Viblio, and Garden Do modules were chosen for their focus on functional, engaging virtual tasks that require movement and balance. VR sessions were conducted for 20-30 minutes each, three times weekly, across 8-week duration. The equipment included VRapeutic immersive rehabilitation system (VRapeutic Inc.); Lenovo IdeaPad 110 laptop (Intel Core i5-6200U CPU, 16 GB RAM, AMD Radeon R5 M430 GPU) running the VRapeutic software (developed with Unity™ 2019.4.40f1 LTS), Oculus Quest 2 VR headset (head-mounted display with 1440×1600 resolution per eye and a 96°×94° field of view), and two Oculus Touch handheld controllers, LED screen (43") was also used to guide the session |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Their Ages ranged from 7to10 years chronologically.
- Both genders will be included.
- They are able to understand and follow simple verbal commands or instructions included in both assessment and training procedures.
- Their degree of spasticity will range from 1 to 1+ according to the Modified Ashworth Scale
- Their motor function will be at level I according to Gross Motor Function Classification System
Key exclusion criteria (4 listed)
- Bony joint limitation or skeletal deformities in lower limb.
- Surgeries (Tenotomy or muscle transfer in the affected lower limb) at last 6 months before the study.
- Botox injection at last 6 months before the study.
- Visual or auditory abnormalities.
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 |
|---|---|---|
| A selected physical therapy programA selected physical therapy program based on NDT principles according to for 60 minutes, 3 times/week for 6 successive weeks including the following exercises: strengthening exercises, stretching exercises, facilitation of postural reactions from standing position including: standing on one leg, weight shifting from standing position, stoop and recover from standing, squat from standing, standing on balance board and pushing the child in different directions and gait training activities for correction of gait pattern including: walking on balance beam, walking on balance board, walking on uneven surface, walking using different obstacles (rolls, wedges, stepper) and walking up and down stairs | Other | Control Group (A), Study Group (B) |
| Fully Immersive Virtual RealityChildren in the study group only were given the same selected program as the control group, along with VR training using two interactive VRapeutic therapeutic games. Viblio, and Garden Do modules were chosen for their focus on functional, engaging virtual tasks that require movement and balance. VR sessions were conducted for 20-30 minutes each, three times weekly, across 8-week duration. The equipment included VRapeutic immersive rehabilitation system (VRapeutic Inc.); Lenovo IdeaPad 110 laptop (Intel Core i5-6200U CPU, 16 GB RAM, AMD Radeon R5 M430 GPU) running the VRapeutic software (developed with Unity™ 2019.4.40f1 LTS), Oculus Quest 2 VR headset (head-mounted display with 1440×1600 resolution per eye and a 96°×94° field of view), and two Oculus Touch handheld controllers, LED screen (43") was also used to guide the session | Other | Study Group (B) |
Primary outcome
Lafayette hand-held dynamometer (HHD)
Time frame: 1. Pre-treatment at base-line of the study. 2. Post-treatment after 8 weeks of intervention.
[Model: 01163, Lafayette Instrument Company, USA] was used for objective measurement of isometric muscle strength of the hip, knee muscle groups. The HHD was calibrated by the manufacturer before assessment. Hip flexors and knee extensors were assessed in a sitting position; hip abductors were assessed in a supine posture; and hip extensors and knee flexors were assessed in a prone position. The child was assessed in three distinct positions: supine, prone, and sitting. The child was asked to perform two warm-up trials at sub maximal effort without the transducer being placed on the limb. Transducer was subsequently placed on the limb, and the child performed three maximal attempts lasting 5 seconds each, with a 30-second rest interval between trials. The child was instructed and verbally prompted to exert maximal force during the test, while the examiner resisted the child's maximal voluntary contraction, representing the maximal isometric force. Peak isometric presented in Newtons.
2 secondary outcomes
Five-Repetition Sit-to-Stand Test (FTSST)
Time frame: 1. Pre-treatment at base-line of the study. 2. Post-treatment after 8 weeks of intervention.
The Pediatric Balance Scale (PBS)
Time frame: 1. Pre-treatment at base-line of the study. 2. Post-treatment after 8 weeks of intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 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.
Gehan H El-Meniawy, Professor study chair
Cairo University; Faculty of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A selected physical therapy program and Fully Immersive Virtual Reality in people with Hemiplegic Cerebral Palsy, run by Adly A Adam 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: finished, as of the sponsor's last update on 28 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lafayette hand-held dynamometer (HHD) (time frame: 1. Pre-treatment at base-line of the study. 2. Post-treatment after 8 weeks of intervention.). 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 28 Aug 2026.