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

NCT04792229 — Not applicable, Completed, 42 participants, Riphah International University

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Registry	NCT04792229
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	42 (Actual)
Sponsor	Riphah International University (Other)
Conditions	Spastic Diplegia
Interventions	Whole Body Viberation (Other)
Dates	start 2020-10-16, primary completion 2021-07-31, completion 2021-08-31, first posted 2021-03-10, last updated 2021-09-23
Locations	1 site in Pakistan

-Summary

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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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Experimental Group	Experimental	Other: Whole Body Viberation	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
Control Group	Active comparator	Other: Whole Body Viberation	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

Whole Body Viberation (Other): WBV device (frequency of 40 Hz), 3 Minute vibration with 3 minute rest

+Outcome measures

Primary outcomes

Modified Ashworth Scale [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
Pediatric Balance Scale [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

Manual Muscle Testing [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)
CP QoL [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.

+Eligibility

Sex: All, ages: 5 Years to 11 Years

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

+Locations (1)

Facility	City	Country	Status
Meshal School of Special Children	Tarbela, Khyber Pakhtunkhwa	Pakistan

+Investigators

Mirza Obaid Baig, Principal investigator, Riphah International University