NCT07827404

Brief Summary

To investigate and compare the effect of Virtual reality and Polymetric exercises on balance, selectivity of the lower extremity and quality of life in children with spastic cerebral palsy. BACKGROUND: Cerebral palsy (CP) can cause a variety of musculoskeletal issues that impact everyday functioning and activities including reduced balance and selective motor control thus improving balance, selective motor control, and quality of life represents a primary goal of pediatric rehabilitation. Various therapeutic interventions have been introduced to enhance lower limb function however, evidence comparing the effectiveness of different treatment approaches remains limited.

Trial Health

65
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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
5mo 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 Progress9%
Sep 2026Feb 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 30, 2027

Expected
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 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

Outcome Measures

Primary Outcomes (2)

  • Biodex

    The Biodex Balance System will be used to assess dynamic postural stability using the Overall Stability Index (OSI). Participants will stand barefoot on the platform with the feet positioned according to the standardized protocol and will be instructed to maintain their balance while the platform moves unpredictably in multiple directions. The test will be performed under standardized conditions, with the participant instructed to maintain the center of balance within the target area throughout the assessment. The OSI will be recorded as an indicator of overall postural stability, with higher OSI values indicating greater instability and poorer balance control.

    three months

  • Selective Control Assessment of the Lower Extremity (SCALE)

    The Selective Control Assessment of the Lower Extremity (SCALE) will be used to assess selective voluntary motor control of the lower extremities. The assessment will evaluate the participant's ability to perform isolated movements of the hip, knee, ankle, and toes while minimizing compensatory movements at the adjacent joints. Each movement will be demonstrated and the participant will be instructed to perform it actively and selectively. Each component will be scored according to the standardized SCALE scoring criteria, with higher scores indicating better selective motor control of the lower extremity.

    three months

Secondary Outcomes (1)

  • Pediatric Quality of Life Inventory CP Module.

    three months

Study Arms (2)

Virtual reality

EXPERIMENTAL

Virtual reality (VR) will be used as an interactive, task-oriented intervention to improve lower-limb motor function and functional mobility. Participants will perform virtual activities involving weight shifting, stepping, squatting, reaching with the lower limbs, balance control, and multidirectional movements. The tasks will require repetitive and goal-directed lower-limb movements within an immersive or interactive virtual environment. Task difficulty will be progressively adjusted according to each participant's functional ability by modifying movement speed, range, task complexity, or level of challenge. Visual and auditory feedback provided by the VR system will be used to facilitate movement accuracy, postural control, and active participation. All VR training will be performed under the supervision of a physiotherapist to ensure appropriate and safe execution of the activities.

Device: Virtual reality (VR)

Polymetric exercises

EXPERIMENTAL

Plyometric exercises will be incorporated to improve lower-limb explosive strength, power, and neuromuscular performance. Participants will perform progressive, rapid stretch-shortening cycle exercises involving jumping, hopping, and landing activities. Exercises will include bilateral and unilateral jumps, forward and lateral hops, and repeated squat jumps, according to the participant's functional ability. Exercise intensity and complexity will be progressively increased by modifying the jumping distance, height, speed, or number of repetitions. Proper landing technique and controlled lower-limb alignment will be emphasized throughout the training to ensure safe and effective performance.

Other: Plyometric exercises

Interventions

Virtual reality (VR) will be used as an interactive, task-oriented intervention to improve lower-limb motor function and functional mobility. Participants will perform virtual activities involving weight shifting, stepping, squatting, reaching with the lower limbs, balance control, and multidirectional movements. The tasks will require repetitive and goal-directed lower-limb movements within an immersive or interactive virtual environment. Task difficulty will be progressively adjusted according to each participant's functional ability by modifying movement speed, range, task complexity, or level of challenge. Visual and auditory feedback provided by the VR system will be used to facilitate movement accuracy, postural control, and active participation. All VR training will be performed under the supervision of a physiotherapist to ensure appropriate and safe execution of the activities.

Virtual reality

Plyometric exercises will be incorporated to improve lower-limb explosive strength, power, and neuromuscular performance. Participants will perform progressive, rapid stretch-shortening cycle exercises involving jumping, hopping, and landing activities. Exercises will include bilateral and unilateral jumps, forward and lateral hops, and repeated squat jumps, according to the participant's functional ability. Exercise intensity and complexity will be progressively increased by modifying the jumping distance, height, speed, or number of repetitions. Proper landing technique and controlled lower-limb alignment will be emphasized throughout the training to ensure safe and effective performance.

Polymetric exercises

Eligibility Criteria

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

You may qualify if:

  • children with cerebral palsy,
  • Age will range as (12:18) years old
  • spastic cerebral palsy
  • level I-II on the GMFCS
  • The child can stand alone.
  • The child is over one meter tall.

You may not qualify if:

  • difficulty to communicate or to understand program instructions
  • surgery/Botox injection during the last 6 months in the lower 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

Cerebral Palsy

Interventions

Plyometric Exercise

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
Assistant Professor of Neurology and Neurosurgery Faculty of Physical Therapy October 6 University

Study Record Dates

First Submitted

September 14, 2026

First Posted

September 18, 2026

Study Start

September 20, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

February 15, 2027

Last Updated

September 18, 2026

Record last verified: 2026-09