NCT07827365

Brief 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. The primary function of the hand is hand grip, which has a great Influence on activities and tasks of daily life

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Sep 2026Jan 2027

First Submitted

Initial submission to the registry

September 14, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

September 20, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2027

Last Updated

September 18, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 14, 2026

Last Update Submit

September 14, 2026

Conditions

Keywords

Virtual Reality, sensorimotor Function, Children, immature Brain Injury

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    three months

Secondary Outcomes (1)

  • Pediatric Quality of Life Inventory CP Module

    three months

Study Arms (2)

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.

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.

Other: Task-oriented circuit training

Interventions

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.

Also known as: VR
Virtual reality (VR)

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.

Task-oriented circuit training

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Lama Saad El-Din SED Mahmoud

CONTACT

Lama Saad El-Din SED Mahmoud

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor Department of Neurology and Neurosurgery

Study Record Dates

First Submitted

September 14, 2026

First Posted

September 18, 2026

Study Start

September 20, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

January 15, 2027

Last Updated

September 18, 2026

Record last verified: 2026-09