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

NCT04792229 | Completed

• 1 other identifier: REC00821 Fatima Aslam
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Spastic Diplegia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Manual Muscle Testing

  4 weeks

• CP QoL

  4 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Whole Body Viberation OTHER

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

Control Group; Experimental Group

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gross motor function classification level II-III
• Modified Ashworth Scale of 1-2

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Meshal School of Special Children

Tarbela, Khyber Pakhtunkhwa, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mirza Obaid Baig

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2021
• First Posted: March 10, 2021
• Study Start: October 16, 2020
• Primary Completion: July 31, 2021
• Study Completion: August 31, 2021
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)