Whole-body Vibration in Spastic Hemiplegic Cerebral Palsy

November 8, 2021 updated by: Riphah International University

Effects of Whole-body Vibration on Spasticity, Balance and Mobility in Spastic Hemiplegic Cerebral Palsy

To target spasticity, balance and mobility whole body vibration exercises along with selected physical therapy is given to experimental group. Control group will receive only selected physical therapy that includes sstretching exercises, gait training, ffacilitation of postural reactions, ffacilitation of standing and weight shift and facilitation of standing balance by using a balance board.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cerebral palsy is the most common childhood disabilities affecting individual's posture and movement. Cerebral palsy is a disorder that causes activity limitations attributed to non-progressive disturbances of the foetal or infant brain that may also affect sensation, perception, cognition, communication, and behavior. Cerebral palsy (CP) results from damage to the developing central nervous system while in utero, during delivery, or during the first two years of life.

The most common movement disorder in Cerebral palsy is a spastic paresis, defined as a posture and movement-dependent tone regulation disorder.The most common signs of the disorder are spasticity, rigidity, muscle weakness, ataxia, balance and movement disorders. Compared to the typically developed children, these children have impaired sensation and increased muscle tone therefore they have trouble voluntarily controlling their muscles. Cerebral Palsy can be grouped based on the motor effects it has on the individual, these can include spastic Cerebral palsy or non-spastic Cerebral palsy. Spastic Cerebral Palsy is the most common type and is associated with tight or contracted muscles.

Cerebral Palsy is more prevalent in more deprived socio-economic populations. Cerebral palsy is a disease that globally has a prevalence of 2 to 3 cases per 1,000 live born neonates. An increase in the prevalence of CP was also seen in low birth weight survivors from the Mersey region of the United Kingdom for the same period. Pilot studies of severe mental retardation conducted in selected populations in Pakistan and India have reported extraordinarily high prevalence estimates in the range of 12-24 /1,000 Spasticity may be defined as a motor disorder characterised by a velocity-dependent exaggeration of stretch reflexes resulting from abnormal intraspinal processing of primary afferent input. The impaired sensation and increase in tone leads to wide range in movement dysfunction. About seventy to eighty percent of children with Cerebral Palsy demonstrate spastic clinical features. Many children with cerebral palsy (CP) have poor walking abilities and manipulation skills. One contributing factor to their problems with gait and reaching movement is poor balance control. Balance control is important as it helps a child to recover from unexpected balance disturbances.Currently, there are many options for the management of spasticity, balance disturbances and risk of fall that includes physical modalities, oral pharmacologic agents, peripheral injectables, intrathecal agents, and surgical interventions, however mostly physical therapy is commonly preferable treatment that includes stretching, NDT, Proprioceptive neuromuscular facilitations,strength training and gait training.

Dynamic mechanical loading of the skeleton is an arduous task and troublesome to induce in children who suffer from severe cerebral palsy. The lack of dynamic weight bearing in this population predisposes them to reduced bone mineral density (BMD) and pre-mature osteoporosis. These children are also more prone to muscle weakness, which contributes to pain, deformity and functional loss. Whole-body vibration training was proposed as a new therapeutic modality for the treatment of the gross motor function, balance and functional performance Whole body vibration (WBV), for which the participant stands on a vibrating platform, delivers low-frequency, low-amplitude mechanical stimuli that enter the human body via the feet. The vibrations stimulate the muscle spindles and alpha motor neuron sending nerve impulses to initiate muscle contractions according to the tonic vibration reflex. Compared to the repetitive passive movement, this WBV protocol adds a muscle strengthening component to the anti-spastic effects. Activity restrictions in spastic cerebral palsy are mainly due to poor postural control. Many interventions like resisting exercises, therapeutic horseback riding, electrical stimulations leads to short term posture and balance improvement. Training using vibration platforms adjunct to exercise has shown to be effective in increasing strength resulting in improved balance and coordination. Whole body vibration has shown to be effective in reducing lower limb spasticity after first application of WBV with a vibration frequency of 12 Hz to 18 Hz ( 2-3 m of amplitude ) for 9 minutes and a significant decrease in tone is observed and even the functional mobility and balance is improved.. During all of the vibration-training sessions, the children will wear the gymnastic shoes to standardize the damping of the vibration due to footwear.

There is paucity in the literature regarding evidence for the safe and effective use of vibration intervention in children with or without pathology and has great effects in spasticity, mobility and improving balance.Chia-Ling Chen concluded that the WBV is an effective intervention for controlling spasticity and improving ambulation. Villarreal et al.showed that 20-week WBV therapy had positive effects on the balance of DS adolescents, although only under specific conditions, with vision and somatosensory input altered.

In previous studies high dosage of whole body vibration has both positive and negative effects. Because this type of treatment seems to improve bone health, The purpose of this intervention is to ensure functional independence in cerebral palsy patients. Whole Body Vibration Therapy has proven to be effective in improving balance by reducing spasticity and improving muscle strength. It is essential to explore new interventions for patients specially for cerebral palsy in whom functional independence is impaired thus their mobility is restricted leading to secondary complications. In my study my goal is to use combination of conventional physical therapy with whole body vibration which can control spasticity and enhance ambulatory performance.

Study Type

Interventional

Enrollment (Actual)

34

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
    • Federal
      • Islamabad, Federal, Pakistan, 46000
        • Riphah International University

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

4 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ashworth scale score +1-3
  • age between 6 and 13 years,
  • able to accept and follow verbal instructions,
  • Gross Motor Function Classification System [GMFCS] levels I-III),

Exclusion Criteria:

  • unstable seizures, any treatment for spasticity or surgical procedures from 3 months (for botulinum toxin type A injections)
  • Suffering from any other condition that interfered with physical activity.

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: Group 1 Experimental group
Stretching, facilitation exercises with whole body vibration
Other: Group 1 Experimental group

Stretching exercises for Achilles tendon, hamstrings, hip flexors and adductors of lower limbs, upper abdominal and pectoralis muscles.

Facilitation of postural reactions, including: facilitation of righting, equilibrium and protective reactions from sitting on ball.

Facilitation of standing and weight shift. Facilitation of standing balance by tilting the child from standing to different directions (forward, back-ward and side-way) using a balance board.

Gait training: by forward, backward, and side-way walking between parallel bars.

Whole body vibration.
Active Comparator: Group 2 Control group
Stretching and facilitation exercises
Other: Group 2 Control group

Stretching exercises for Achilles tendon, hamstrings, hip flexors and adductors of lower limbs, upper abdominal and pectoralis muscles.

Facilitation of postural reactions, including: facilitation of righting, equilibrium and protective reactions from sitting on ball.

Facilitation of standing and weight shift. Facilitation of standing balance by tilting the child from standing to different directions (forward, back-ward and side-way) using a balance board.

Gait training: by forward, backward, and side-way walking between parallel bars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth
Time Frame: Change from Baseline spasticity to 3 months
It is used to check spasticity and consists of 6 grades from 0-4
Change from Baseline spasticity to 3 months
6-Minute walking test (6MWT)
Time Frame: Change from Baseline mobility level to 3 months
It is used to test mobility of participant. The 6-minute walk test (6MWT) is a standardized, self-paced walking test commonly used to assess functional ability in different populations.
Change from Baseline mobility level to 3 months
Paediatric Balance Scale
Time Frame: Change from Baseline balance to 3 months
The Pediatric Balance Scale (PBS), a modification of the BBS, was developed as a balance measure for children with mild to moderate motor impairments and has good test-retest and interrater reliability. The PBS is a 14-item, criterion-referenced measure and examines functional balance in the context of everyday tasks
Change from Baseline balance to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go test (TUG)
Time Frame: Change from Baseline mobility and balance to 3 months
TUG is a test used to assess a person's mobility. TUG measured the time required for an individual to stand up from a chair with armrests, walk 3 m, turn, walk back to the chair, and sit down.
Change from Baseline mobility and balance to 3 months
Sit-To-Stand (STS) test
Time Frame: Change from Baseline mobility and balance to 3 months
Sit to stand test is a reliable tool for measuring lower limb functional strength and balance ability.
Change from Baseline mobility and balance to 3 months

Collaborators and Investigators

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

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Misbah Ghous, MSNMPT*, 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)

September 15, 2019

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

September 4, 2019

First Submitted That Met QC Criteria

September 11, 2019

First Posted (Actual)

September 12, 2019

Study Record Updates

Last Update Posted (Actual)

November 10, 2021

Last Update Submitted That Met QC Criteria

November 8, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/00555 kainat Ameer

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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