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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04792229
Enrollment
42
Registered
2021-03-10
Start date
2020-10-16
Completion date
2021-08-31
Last updated
2021-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spastic Diplegia

Brief 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.

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.

Interventions

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

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 11 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Modified Ashworth Scale4 weeksthe 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 Scale4 weeksan 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

MeasureTime frameDescription
Manual Muscle Testing4 weeksTo 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 QoL4 weeksCp 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026