Brain Injuries, FocalNCT07827365
VR Versus Task-Oriented Circuit Training on UL Sensorimotor in Children With Immature Brain Injury
A study testing Virtual reality and Task-oriented circuit training in people with Brain Injuries, Focal, run by October 6 University.
Trial summary
To investigate and compare the effect of virtual reality and task-oriented circuit training on pinch grip and quality of life in children with with immature brain injury. BACKGROUND: Children with immature brain injury may have limited use of their hands for functional activities and for fine motor skills. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Brain Injuries, Focal
- What is being tested?
- Virtual reality and Task-oriented circuit training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 15 Jan 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Forty four children with cerebral palsy,
- Age will range as (12:18) years old
- spastic cerebral palsy
- Gross motor function classification system: level I\&II
- level I-III on the Manual Ability Classification System (MACS)
Who cannot join
- difficulty to communicate or to understand program instructions
- surgery/Botox injection during the last 6 months in the upper extremity
- uncontrolled severe seizures
- fixed deformities in the affected side;
- Attention deficit/hyperactivity disorders.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Virtual Reality Versus Task-Oriented Circuit Training on Upper Limb Sensorimotor Function in Children With Immature Brain Injury :Randomized Controlled Trial
To investigate and compare the effect of virtual reality and task-oriented circuit training on pinch grip and quality of life in children with with immature brain injury. BACKGROUND: Children with immature brain injury may have limited use of their hands for functional activities and for fine motor skills. The primary function of the hand is hand grip, which has a great Influence on activities and tasks of daily life
Read the detailed description
To investigate and compare the effect of virtual reality and task-oriented circuit training on pinch grip and quality of life in children with with immature brain injury. BACKGROUND: Children with immature brain injury may have limited use of their hands for functional activities and for fine motor skills. The primary function of the hand is hand grip, which has a great Influence on activities and tasks of daily life
Hypothesis
This study hypothesized that:
there is no difference between the effect of virtual reality and task-oriented circuit training on pinch grip and quality of life in children with spastic cerebral palsy.
RESEARCH QUESTION:
Is there difference between the effect of virtual reality and task-oriented circuit training on pinch grip and quality of life in children with immature brain injury?
- Conditions
- Brain Injuries, Focal
- Being tested
- Virtual reality, Task-oriented circuit training
- Keywords
- Virtual Reality, sensorimotor Function, Children, immature Brain Injury
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
Also called VR
Virtual reality (VR) will be applied as an interactive, task-oriented rehabilitation intervention targeting upper-extremity function. Participants will perform virtual tasks involving purposeful reaching, grasping, object manipulation, and directional movements of the affected upper limb. The difficulty and range of the tasks will be progressively adjusted according to each participant's functional ability to encourage active movement, repetitive practice, and motor learning.
Task-oriented circuit trainingOther
Task-oriented circuit training will be provided to improve upper-extremity functional performance through repetitive, goal-directed activities. Participants will perform a series of functional tasks involving reaching, grasping, lifting, transferring, and manipulating objects. The training will be organized as a circuit of exercise stations, with each station targeting a specific upper-extremity functional skill. Tasks will be progressively modified by increasing the movement complexity, speed, repetitions, or task demands according to the participant's functional ability. Participants will receive verbal instructions and feedback from the physiotherapist to facilitate accurate task performance and encourage active participation.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality (VR) | Experimental | Virtual reality (VR) will be applied as an interactive, task-oriented rehabilitation intervention targeting upper-extremity function. Participants will perform virtual tasks involving purposeful reaching, grasping, object manipulation, and directional movements of the affected upper limb. The difficulty and range of the tasks will be progressively adjusted according to each participant's functional ability to encourage active movement, repetitive practice, and motor learning. Receives: Device: Virtual reality |
| Task-oriented circuit training | Experimental | Task-oriented circuit training will be provided to improve upper-extremity functional performance through repetitive, goal-directed activities. Participants will perform a series of functional tasks involving reaching, grasping, lifting, transferring, and manipulating objects. The training will be organized as a circuit of exercise stations, with each station targeting a specific upper-extremity functional skill. Tasks will be progressively modified by increasing the movement complexity, speed, repetitions, or task demands according to the participant's functional ability. Participants will receive verbal instructions and feedback from the physiotherapist to facilitate accurate task performance and encourage active participation. Receives: Other: Task-oriented circuit training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pinch dynamometer
Pinch strength will be assessed using a pinch dynamometer to quantify the maximal voluntary pinch force of the affected hand. The dynamometer will be positioned between the thumb and the specified finger(s), and participants will be instructed to apply maximal pinch force for approximately 3-5 seconds. Three trials will be performed with adequate rest between trials, and the highest recorded value or mean of the three trials will be used for analysis.
Measured: three months
fugl myer assessment for sensorimotor function of upper limb
The Fugl-Meyer Assessment (FMA) will be used to evaluate sensorimotor function of the upper extremity. The upper-extremity section of the FMA will assess motor function, reflex activity, coordination, and speed of movement. The assessment will include movements of the shoulder, elbow, forearm, wrist, and hand, with each item scored according to the standardized FMA scoring system. Higher scores will indicate better sensorimotor performance of the affected upper extremity
Measured: three months
Secondary outcomes (1)
Pediatric Quality of Life Inventory CP Module
The Pediatric Quality of Life Inventory Cerebral Palsy Module (PedsQL CP Module) will be used to assess health-related quality of life in children with cerebral palsy. The questionnaire will evaluate the child's perceived difficulties and limitations across cerebral palsy-specific domains, including daily activities, movement and balance, pain and hurt, fatigue, eating activities, and communication, as applicable to the child's age and functional level. Items will be scored according to the standardized PedsQL CP Module scoring system, with higher scores indicating better health-related quality of life.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, FocalStudies 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
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lama Saad El-Din Mahmoud, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827365
- Sponsor's protocol ID
- P.T.REC/012/006486
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- 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 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Versus Task-Oriented Circuit Training on Upper Limb Sensorimotor Function in Children With Immature Brain Injury :Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07827365
- Acronym / sponsor ID
- P.T.REC/012/006486
- Conditions
- Brain Injuries, Focal
- Keywords
- Virtual Reality, sensorimotor Function, Children, immature Brain Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 18 Sep 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.
To investigate and compare the effect of virtual reality and task-oriented circuit training on pinch grip and quality of life in children with with immature brain injury. BACKGROUND: Children with immature brain injury may have limited use of their hands for functional activities and for fine motor skills. The primary function of the hand is hand grip, which has a great Influence on activities and tasks of daily life
Detailed description
To investigate and compare the effect of virtual reality and task-oriented circuit training on pinch grip and quality of life in children with with immature brain injury. BACKGROUND: Children with immature brain injury may have limited use of their hands for functional activities and for fine motor skills. The primary function of the hand is hand grip, which has a great Influence on activities and tasks of daily life
Hypothesis
This study hypothesized that:
there is no difference between the effect of virtual reality and task-oriented circuit training on pinch grip and quality of life in children with spastic cerebral palsy.
RESEARCH QUESTION:
Is there difference between the effect of virtual reality and task-oriented circuit training on pinch grip and quality of life in children with immature brain injury?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality (VR) | Experimental | Device: Virtual realityVirtual reality (VR) will be applied as an interactive, task-oriented rehabilitation intervention targeting upper-extremity function. Participants will perform virtual tasks involving purposeful reaching, grasping, object manipulation, and directional movements of the affected upper limb. The difficulty and range of the tasks will be progressively adjusted according to each participant's functional ability to encourage active movement, repetitive practice, and motor learning. |
| Task-oriented circuit training | Experimental | Other: Task-oriented circuit trainingTask-oriented circuit training will be provided to improve upper-extremity functional performance through repetitive, goal-directed activities. Participants will perform a series of functional tasks involving reaching, grasping, lifting, transferring, and manipulating objects. The training will be organized as a circuit of exercise stations, with each station targeting a specific upper-extremity functional skill. Tasks will be progressively modified by increasing the movement complexity, speed, repetitions, or task demands according to the participant's functional ability. Participants will receive verbal instructions and feedback from the physiotherapist to facilitate accurate task performance and encourage active participation. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Forty four children with cerebral palsy,
- Age will range as (12:18) years old
- spastic cerebral palsy
- Gross motor function classification system: level I\&II
- level I-III on the Manual Ability Classification System (MACS)
Key exclusion criteria (5 listed)
- difficulty to communicate or to understand program instructions
- surgery/Botox injection during the last 6 months in the upper extremity
- uncontrolled severe seizures
- fixed deformities in the affected side;
- Attention deficit/hyperactivity disorders.
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: VRVirtual reality (VR) will be applied as an interactive, task-oriented rehabilitation intervention targeting upper-extremity function. Participants will perform virtual tasks involving purposeful reaching, grasping, object manipulation, and directional movements of the affected upper limb. The difficulty and range of the tasks will be progressively adjusted according to each participant's functional ability to encourage active movement, repetitive practice, and motor learning. | Device | Virtual reality (VR) |
| Task-oriented circuit trainingTask-oriented circuit training will be provided to improve upper-extremity functional performance through repetitive, goal-directed activities. Participants will perform a series of functional tasks involving reaching, grasping, lifting, transferring, and manipulating objects. The training will be organized as a circuit of exercise stations, with each station targeting a specific upper-extremity functional skill. Tasks will be progressively modified by increasing the movement complexity, speed, repetitions, or task demands according to the participant's functional ability. Participants will receive verbal instructions and feedback from the physiotherapist to facilitate accurate task performance and encourage active participation. | Other | Task-oriented circuit training |
Primary outcome
Pinch dynamometer
Time frame: three months
Pinch strength will be assessed using a pinch dynamometer to quantify the maximal voluntary pinch force of the affected hand. The dynamometer will be positioned between the thumb and the specified finger(s), and participants will be instructed to apply maximal pinch force for approximately 3-5 seconds. Three trials will be performed with adequate rest between trials, and the highest recorded value or mean of the three trials will be used for analysis.
fugl myer assessment for sensorimotor function of upper limb
Time frame: three months
The Fugl-Meyer Assessment (FMA) will be used to evaluate sensorimotor function of the upper extremity. The upper-extremity section of the FMA will assess motor function, reflex activity, coordination, and speed of movement. The assessment will include movements of the shoulder, elbow, forearm, wrist, and hand, with each item scored according to the standardized FMA scoring system. Higher scores will indicate better sensorimotor performance of the affected upper extremity
1 secondary outcome
Pediatric Quality of Life Inventory CP Module
Time frame: three 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 18 Sep 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.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality and Task-oriented circuit training in people with Brain Injuries, Focal, run by October 6 University.
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 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Lama Saad El-Din SED Mahmoud (01157592636, lamaelsedawyy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pinch dynamometer (time frame: three 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 Sep 2026.