- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07827404
VR Versus Plyometric Exercise on Lower Limb Motor Control and Balance in Spastic Hemiplegic Children
Effect of Virtual Reality-Based Therapy Versus Plyometric Exercise Training on Lower Limb Selective Motor Control , Balance and Quality of Life in Spastic Hemiplegic Children : a Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Hypothesis
This study hypothesized that:
there is no difference between the effect of virtual reality and polymetric exercises on balance, selective motor control in lower extremity and quality of life in children with spastic cerebral palsy.
RESEARCH QUESTION:
Is there difference between the effect of virtual reality and polymetric exercises on balance, selective motor control in lower extremity and quality of life in children with spastic cerebral palsy?
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual reality
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 (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.
|
|
Experimental: Polymetric exercises
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biodex
Time Frame: three months
|
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)
Time Frame: three months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric Quality of Life Inventory CP Module.
Time Frame: three months
|
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 module will evaluate cerebral palsy-specific aspects of the child's physical, emotional, social, and functional well-being.
Items will be rated using the standardized response scale, and scores will be calculated according to the PedsQL scoring guidelines.
Higher scores will indicate better health-related quality of life.
|
three months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Brain Damage, Chronic
- Cerebral Palsy
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Physical Conditioning, Human
- Exercise
- Plyometric Exercise
Other Study ID Numbers
- P.T.REC/012/006485
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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