Vestibular and Motor Functions in Children With Hemiplegic Cerebral Palsy

February 20, 2022 updated by: Riphah International University

The Effect of Vestibular Stimulation Along With Neurodevelopmental Technique on Motor Functions of Children With Hemiplegic Cerebral Palsy

As many researches have been conducted to see the effects of vestibular system activation on gross motor activities of children with cerebral palsy but there are limited researches on improvement of motor abilities of hemiplegic cerebral palsy child using UEU or BOSU ball or treadmill in a single study. There is lack of research on vestibular stimulation in hemiplegic cerebral palsy along with neurodevelopmental treatment.

This study will improve the gross motor activities of children with hemiplegic cerebral palsy. It will broaden up the ways for physical therapist to deal with this type of cerebral palsy (hemiplegic).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There are various therapeutic approaches that are used to improve motor activities and postural control in CP child. Among these approaches vestibular stimulation is used to improve neuromotor development by different sensory stimulation techniques. It has shown positive effects on motor control of CP child. It also influences all sensory experiences and is an exercise based approach.

Study Type

Interventional

Enrollment (Actual)

28

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
    • Punjab
      • Lahore, Punjab, Pakistan
        • Institute of Pediatric Habilitation and Rehabilitation IPH

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

3 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 3 years to 12 years
  • Gender: Both Male and female
  • Children with Spastic Hemiplegic CP scoring 1,1+ and 2 on Modified Ashworth scale
  • Level III and IV on GMFCS (Gross Motor Function Classification System)

Exclusion Criteria:

  • Children with other types of Cerebral Palsy (diplegia, quadriplegia etc)
  • Children with other Abnormalities and pathologies (delayed milestones, hydrocephalous, epilepsy etc)
  • Children Undergone any kind of surgery (cardiac, shunt placement, orthopedic etc)
  • Children with any other neurological deficits (spina bifida etc)
  • Children with conditions in which vestibular stimulation is not allowed (paroxysmal positional vertigo or vestibular neuritis, Meniere's disease, migraine-associated vertigo, and childhood vertigo).

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group A
Neurodevelopmental Treatment. Total duration of treatment will be 20 minutes, 3 sessions per for 3 months
Other: Neurodevelopmental technique
  1. st month: postural maintenance; exercises with weight on forearms and hands, in sitting, crawling, semi-kneeling and standing positions with support from therapist.
  2. nd month: balance and corrective reactions; using CP ball and tilt board.
  3. rd month: ambulation training; appropriate to motor development level (crawling, creeping, walking in a semi-kneeling position and walking between parallel bars).
EXPERIMENTAL: Group B
Neurodevelopmental Technique and Vestibular stimulation. Total duration of treatment will be 50 minutes (20 min NDT+ 30 MIN VS) 3 sessions per week for 3 months.
Other: Neurodevelopmental technique
  1. st month: postural maintenance; exercises with weight on forearms and hands, in sitting, crawling, semi-kneeling and standing positions with support from therapist.
  2. nd month: balance and corrective reactions; using CP ball and tilt board.
  3. rd month: ambulation training; appropriate to motor development level (crawling, creeping, walking in a semi-kneeling position and walking between parallel bars).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GMFM-88
Time Frame: 12 weeks
It is a Standardized Observational Instrument designed and validated to measure change in gross motor function over time in children with Cerebral Palsy. The GMFM-88 item scores can be summed to calculate raw and percent scores for each of the five GMFM dimensions of interest, selected goal areas and a total GMFM-88 score.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth Scale
Time Frame: 12 weeks
The purpose of the Modified Ashworth Scale is to measure spasticity in patients who have lesions of the CNS or neurological disorders. The MAS is a quick and easy measure that can assist a clinician's assessment of spasticity during passive soft-tissue stretching.
12 weeks

Collaborators and Investigators

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

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Mirza Obaid Baig, MSPT, 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, 2021

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ACTUAL)

January 31, 2022

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (ACTUAL)

May 20, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 22, 2022

Last Update Submitted That Met QC Criteria

February 20, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/00757 Anam Tariq

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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