Tele-rehabilitation in Children With Cerebral Palsy in the Covid-19 Pandemic

October 29, 2021 updated by: Engin Ramazanoglu, Inonu University

The Effect of Motor Learning Based Tele-rehabilitation on Quality of Life in Children With Cerebral Palsy During the Covid-19 Epidemic Process

The investigators study aimed to observe the effect of motor learning-based tele-rehabilitation on quality of life in children with cerebral palsy during the Covid-19 pandemic.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cerebral palsy; It is defined as a permanent, non-progressive disorder that occurs as a result of the effects of the developing fetal or infant brain for different reasons in prenatal, perinatal or postnatal periods. Children with cerebral palsy experience fundamental limitations in the postural control of static and dynamic tasks such as sitting, standing, and walking. However, children with cerebral palsy need rehabilitation. The COVID-19 pandemic prevents effective provision of rehabilitation services for children with cerebral palsy. However; Lack of access to rehabilitation services in individuals with cerebral palsy during the COVID-19 pandemic has increased the need for alternative and complementary methods. During the Covid-19 pandemic process, the tele-rehabilitation process will be able to achieve functional and social participation in children with cerebral palsy.

Study Type

Interventional

Enrollment (Anticipated)

30

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

  • Turkey
      • Malatya, Turkey, 44000
        • Recruiting
        • Inonu University
        • Contact:

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 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children with spastic cerebral palsy, ages 3-16
  • To be at 1-2-3 levels according to GMFCS
  • The tele-rehabilitation group is not receiving treatment in any center.
  • Voluntary participation in the study with the consent of the parents

Exclusion Criteria:

  • Application of muscle tone reduction 6 months before the start of the study (eg botulin toxin, baclofen pump therapy) or those undergoing orthopedic surgery.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Telerehabilitation and motor learning principles will be applied.
Other: Telerehabilitation İntervention, Motor learning

Telerehabilitation İntervention:

Training videos will be sent to the families of the children in the tele-rehabilitation group before starting to work. With the training videos, it is aimed to teach the exercises to be done to the families. Treatment will be applied by their families for 8 weeks, 2 days a week, 40 minutes a day. Physiotherapist will attend the sessions by video conference method. Video conference calls will be made by phone over the WhatsApp application.

Motor learning:

The first 10 minutes will start with active stretching Functional lying in a sitting position, Functional lying with feet together in a standing position. rolling the pilates ball on the wall, walking on its side. Going up and down stairs at different heights. Walking across different surfaces and obstacles. Getting up from chairs of different heights, sitting and extending the object taken from the ground. Functional exercises suitable for the child's level.
Experimental: Control Group
Motor learning principles will be applied in the clinic.
Other: Telerehabilitation İntervention, Motor learning

Telerehabilitation İntervention:

Training videos will be sent to the families of the children in the tele-rehabilitation group before starting to work. With the training videos, it is aimed to teach the exercises to be done to the families. Treatment will be applied by their families for 8 weeks, 2 days a week, 40 minutes a day. Physiotherapist will attend the sessions by video conference method. Video conference calls will be made by phone over the WhatsApp application.

Motor learning:

The first 10 minutes will start with active stretching Functional lying in a sitting position, Functional lying with feet together in a standing position. rolling the pilates ball on the wall, walking on its side. Going up and down stairs at different heights. Walking across different surfaces and obstacles. Getting up from chairs of different heights, sitting and extending the object taken from the ground. Functional exercises suitable for the child's level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Quality of Life Inventory
Time Frame: 8 weeks
The 35-item PedsQL consists of seven subscales: Daily Activities, School Activities, Movement and Balance, Pain, Fatigue, Eating Activities, Speaking and Communication. The scale consists of a child self-report and a parent report. The scale questions the degree of problems the children have experienced in the last month. Item scores are converted linearly backwards on a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so higher scores indicate better health-related quality of Life.Subscale scores are calculated by dividing the total score of the items answered by the number of items answered. There is no scale total score, subscales have calculated mean scores. The higher the average score for an area (subscale) indicates that there are fewer problems in that area and the higher the quality of life.
8 weeks

Collaborators and Investigators

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

Sponsor

Inonu 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)

August 27, 2021

Primary Completion (Actual)

October 27, 2021

Study Completion (Anticipated)

October 27, 2021

Study Registration Dates

First Submitted

May 14, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 21, 2021

Study Record Updates

Last Update Posted (Actual)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 29, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/1422

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The information of the patients participating in the study will be kept confidential.

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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