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NCT Number: NCT04792229

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

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.

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Key information

Conditions

Spastic Diplegia Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meshal School of Special Children

Tarbela, Khyber Pakhtunkhwa, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole Body Viberation

Other

WBV device (frequency of 40 Hz), 3 Minute vibration with 3 minute rest

Primary outcomes

  1. Modified Ashworth Scale

    Time frame: 4 weeks

    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

  2. Pediatric Balance Scale

    Time frame: 4 weeks

    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

Secondary outcomes

  1. Manual Muscle Testing

    Time frame: 4 weeks

    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)

  2. CP QoL

    Time frame: 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2021
Registry last updated
Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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