Effects Of Whole Body Vibration On Lower Extremity With Diplegic Spastic Cerebral Palsy

Study Overview
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Brief Summary
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This study will help to determine the beneficial effects of high frequency vibration on children with diplegic cerebral palsy in improving balance ,spasticity, strength of lower limb and quality of life and a comparison between the effect of simple conventional treatment and conventional management with the usage of vibrational therapy in cp patients.

Detailed Description
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A study Effect of whole body vibration training on mobility in children with cerebral palsy states Whole body vibrational therapy induce an improvement in independent ambulation and mobility of lower limb by strengthening of muscles along with the refinement of walking pattern ,gait speed and stride length in children with cerebral palsy. On the basis of our study a better treatment protocol can be designed for future in diplegic spastic cerebral palsy children.

Official Title
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Effects Of Whole Body Vibration On Lower Extremity With Diplegic Spastic Cerebral Palsy

Conditions
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Spastic Diplegia

Intervention / Treatment
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* Other: Whole Body Viberation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gross motor function classification level II-III Modified Ashworth Scale of 1-2 Exclusion Criteria: Auditory/ visually impaired Other neurological conditions e.g. spina bifida etc. Lower limb contractures Children with history of lower limb surgery in last 6 months

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Standing on WBV device (frequency of 40 Hz); 3 Minute vibration with 3 minute rest. Three times repetition . Total 18-minute vibrational therapy protocol. 3 days session per week | Other: Whole Body Viberation<br>* WBV device (frequency of 40 Hz), 3 Minute vibration with 3 minute rest<br>|
| Active Comparator: Control Group<br>Stretching exercise (hip adductors ,plantar flexors, external rotators of hip & knee flexors). Active and passive ROMS to lower extremities. Strengthening exercises (hip and knee extensors, ankle dorsiflexes) 3 Repetitions into 3 day session per week | Other: Whole Body Viberation<br>* WBV device (frequency of 40 Hz), 3 Minute vibration with 3 minute rest<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ashworth Scale | the gold standard clinical tool, widely used for the measurement of the increased muscle tone and for grading the spasticity of the muscle. This scale is categorized in to 5 grades ranging from score 0 to 4. where 0 indicating normal muscular tone and 4 indicating marked spasticity of muscle. The intra class correlation coefficient for MAS is 0.92 | 4 weeks | 
| Pediatric Balance Scale | an upgraded version of berg balance scale (inter-tester reliability of 0.997 and test-retest reliability of 0.9989) used for the assessment of the balance of school age children having mild to moderate level of developmental disorders , motor impairment or with brain lesion while performing functional activities | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manual Muscle Testing | To assess the muscle strength, in clinical settings as well as in research trials evaluation done either manually with Manual Muscle Testing (MMT) or instrumentally by using a dynamometers .Inter-rater reliability of MMT is ICC 0.79-0.92) | 4 weeks | 
| CP QoL | Cp QOL have two versions :Primary caregiver (for parents of 4-12 aged children), composed of 65 items and Child self-report version (for children of 9-12 years of age ), 53 items questionnaire. Cp QOL (Caregiver ) is further Categorized into seven domains, Social wellbeing and acceptance, Participation and physical health, Feelings about functioning, Emotional wellbeing and self-esteem, Pain and impact of disability, Access to services, Family health. | 4 weeks |