Whole Body Vibration Effect on Trunk Control, Functional Performance and Selective Control

March 10, 2025 updated by: Riphah International University

Effect of Whole Body Vibration Effect on Trunk Control, Functional Performance and Selective Control of Lower Extremity in Children With Cerebral Palsy

Permanent neurological disorders such as cerebral palsy lead to problems with motor, sensory, and cognitive functions, which in turn limit one's ability to do certain activities. While the exact causes of cerebral palsy differ from child to child, anoxia-induced brain injury is a major cause of the disorder. The body parts affected, tone, and involuntary motions are used to categorise cerebral palsy. Among all the forms, spastic CP is the most prevalent. In individuals with CP, postural stabilisation and adaptations of the head, trunk, pelvic, and shoulder girdles grow more slowly. The primary problem with CP children is their gross movement pattern, which prevents them from performing single joint movements. Muscle strength increases significantly with WBV exercise training, which also reduces spasticity and enhances CP children's motor function. This study is important because it will determine whether WBV improves trunk control, functional performance, and lower limb selective control.

Data from Rising Sun Institute will be gathered for this randomised clinical trial. 38 patients will be included in the study. The study's inclusion criteria will include CP children with ages between 6 and 12 years old, those who can stand or walk alone (even with unusual gait patterns), GMFCS I and II, and children with diplegic cerebral palsy. Children with cerebral palsy (CP) who have had a lower limb fracture, fixed contracture, or other deformity, as well as those who have had a botulinum toxin injection or selective dorsal rhizotomy within the last six months, will not be eligible. Stretching exercises, strengthening exercises, trunk control facilitation, and rightening reaction facilitation will be the specific physical therapy treatments administered to group A. In addition, group B will receive WBV in addition to the specific physical therapy treatments (stretching exercises, strengthening exercises, trunk control facilitation, and rightening reaction facilitation). For two months, the 30-minute sessions will be held three times a week. The Modified Trost Test will test selective lower limb control, the PEDI scale will assess functional performance, and the Trunk Control Measurement Scale will monitor trunk stability before and after sessions. SPSS version 26 will be utilised for data analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Lahore, Pakistan, 54792
        • Pakistan Society for Rehabilitation of Disabled

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • Childrens who follow verbal command

    • Childrens who can stand or walk alone (either with altered pattern)
    • Age limit: 6 -12 years
    • GMFCS I & II
    • Diplegic Cerebral palsy

Exclusion Criteria:

  • • Childrens with history of fracture in last 6 months

    • Childrens with fixed contracture or other deformity of lower limb
    • Childrens having visual or auditory impairments
    • Selective dorsal rhizotomy or botulinum toxin injection to lower extremities within past six months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: whole body vibration group
Other: conventional therapy
This group will be provided with the conventional physical therapy. To this, stretching activities to keep up muscle elasticity particularly Achilles tendon, hamstring muscles, hip flexors and adductors; strength training to hip flexor, knee extensor, and ankle dorsiflexor;
Other: Whole Body Vibration group
This group will be given WBV training session, by using a WBV platform was conducted to the study group. The wBV program comprises various positions such as the child stands in an erect position, sitting, and in kneeling position on vibrating platform. This platform vibrates horizontally at a frequency ranged from 10 to 25 Hz. The participants had to carry out each position for 2 min in the first month, and then it was increased to 3 min in the second month. The rest period between each position was 1 min in the first month, then it became half a minute in the second month. The duration of the vibration exposure was 10 min.
Active Comparator: conventional therapy group
Other: conventional therapy
This group will be provided with the conventional physical therapy. To this, stretching activities to keep up muscle elasticity particularly Achilles tendon, hamstring muscles, hip flexors and adductors; strength training to hip flexor, knee extensor, and ankle dorsiflexor;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
.Trunk Control Measurement Scale (TCMS) for trunk control
Time Frame: Baseline to 8 weeks
To access trunk control in CP child we choose TCMS, it assesses seated trunk control in three dimensions static sitting balance, dynamic sitting balance and dynamic reaching. The maximum score is 58 points. The items are scored from 0 to 3, with 0 being the inability to perform the task and 3 being the complete performance of the item (20).
Baseline to 8 weeks
Modified Trost Test for selective control of lower extremity
Time Frame: Baseline to 8 weeks

This test is used for assessment of selective motor control of lower extremity. It is a 3-point scale with assessment of ankle dorsiflexion, knee extension, hip flexion and hip abduction.

  • 0 point for Only patterned movement observed (total synergy)
  • 1 for Partially isolated movement observed (partial synergy)
  • 2 for Completely isolated movement observed (no synergy)
Baseline to 8 weeks
PEDI SCALE for functional performance
Time Frame: Baseline to 8 weeks

This scale is use for assessment of functional performance. It is composed of 197 items, subdivided into three domains(22).

Mobility (59 items, involving tub transfers, toilet transfers, indoor and outdoor locomotion, and climbing stairs); Self-care (73 items involving eating, dressing, grooming); Social function (65 items related to communication with comprehension and expression, problem-solving, interactions with peers and adults and safety awareness).

Each item scores (0) for "unable" to perform the activities or (1) for "capable
Baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Fareeha Kausar, PP-DPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2024

Primary Completion (Actual)

August 15, 2024

Study Completion (Actual)

August 30, 2024

Study Registration Dates

First Submitted

June 12, 2024

First Submitted That Met QC Criteria

June 12, 2024

First Posted (Actual)

June 17, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/PCR&AHS/23/0771

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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