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

Spastic Diplegia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04792229
• Other study ID #: REC00821 Fatima Aslam
• Status: Completed
• Phase: N/A
• Start date: October 16, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: September 2021
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Spastic Diplegia

Intervention

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

Locations

Country	Name	City	State
Pakistan	Meshal School of Special Children	Tarbela	Khyber Pakhtunkhwa

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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