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The Effect of Telerehabilitation on the Children With Cerebral Palsy and Their Caregivers

Primary Purpose

Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation
Control
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cerebral Palsy focused on measuring cerebral palsy, telerehabilitation

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of Spastic Hemiplegic and Diplegic Cerebral Palsy in participating children confirmed by pediatric neurologists

Being GMFCS I and II

Spasticity value of 1, 2 or maximum 3 in the evaluation made with Modified Ashworth Scale (MAS) on lower extremity muscles

Being able to stand and walk without using any auxiliary equipment

Being mentally capable of reading the commands of the assessment.

Agree to participate in the study

Exclusion Criteria:

Not having ambulation

Having a cognitive disorder

Having undergone any orthopedic surgery or spasticity replacement procedure in the past 12 months

Having vision problems except refraction

Having any known systemic problems

Having an uncontrolled epileptic seizure

Having lower extremity contracture that affects the evaluation

The occurrence of any health problems that could affect the work

Refusing to participate in the study

Sites / Locations

  • Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

telerehabilitation

control

Arm Description

The exercises will be applied twice a week for a total of 12 weeks, and each program will last roughly 30 minutes.

The same exercise program will be prepared and given as a printout and they will be asked to do their exercises at home. This group will also be included in the study as a control group.

Outcomes

Primary Outcome Measures

CP-QOL-Child ve Teen
Evaluates the quality of life in Cerebral Palsy.
Revised Child Anxiety and Depression Scale
It was developed to screen for anxiety disorders and depression.
STAI-State Trait Anxiety Inventory
It is a self-evaluation questionnaire consisting of short statements.
BECK Depression Inventory
It will be applied in determining depression levels.

Secondary Outcome Measures

Full Information

First Posted
June 6, 2021
Last Updated
June 6, 2021
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT04923438
Brief Title
The Effect of Telerehabilitation on the Children With Cerebral Palsy and Their Caregivers
Official Title
The Effect of Telerehabilitation on the Quality of Life, Anxiety and Depression Levels of Children With Cerebral Palsy and Their Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
June 12, 2021 (Anticipated)
Study Completion Date
June 26, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cerebral palsy develops due to brain damage before, during and after birth. Motor control is impaired in individuals with cerebral palsy. Disturbances occur in muscle tone, mobility and body posture. There is no definitive treatment for cerebral palsy, but improvement in functions can be achieved with physiotherapy. Because of the covid-19 pandemic precautions, activity level has been decreasing in children with cerebral palsy, as in adults. Children experience physical, social and psychological problems caused by physical inactivity. Exercises and games that can be done comfortably in the house will positively affect the physical development of children and enable them to spend productive time by getting away from excessive technology, internet and smart phone usage, excessive screen time. The aim of this project; To ensure that children with cerebral palsy who need intense exercise and activity and who experience physical inactivity due to COVID-19 can exercise with telerehabilitation and to determine the effect of telerehabilitation on the quality of life, anxiety and depression levels of children with cerebral palsy and their caregivers. It will be compared to a control group that did not accept telerehabilitation but was recommended to exercise at home.
Detailed Description
Cerebral palsy (SP); It is a group of permanent neuromotor disorders affecting movement, muscle tone and posture development as a result of non-progressive damage to the brain in the prenatal and neonatal period. In children with CP, it is observed that primitive reflexes continue, correction reactions occur late, muscle weakness, spasticity, loss of coordination and normal motor control cannot develop. Clinically SP; Spastic, dyskinetic, ataxic and mixed types are divided into four groups as SP. Although there is no definitive treatment for CP, physiotherapy applications are of great importance in the treatment of problems. With physical therapy exercises, it is known that children with CP progress in factors such as postural control, muscle strength, flexibility, balance, physical activity capacity, mental well-being, participation in social life. The COVID-19 (coronavirus) pandemic, which has recently surrounded the whole world, has caused serious measures to be taken in all areas in our country. Serious warnings are made that everyone should stay at home. During this period, physical activity levels of children as well as adults decreased significantly. Children experience physical, social and psychological problems caused by physical inactivity. Exercises and games that can be done easily in the house will positively affect the physical development of children and enable them to spend productive time by getting away from excessive technology, internet and smart phone usage, excessive screen time. (aerobic) and stretching activities. Physical activity programs that are age-appropriate, fun and diverse should be created for children. In addition, games for physical activity in the family; It is also thought that it will increase socialization within the family, that individuals will listen to each other more, understand, share more, and prevent some anxiety and stress caused by coronavirus. The aim of this project; To ensure that children with cerebral palsy who need intense exercise and activity and who experience physical inactivity due to COVID-19 can exercise with telerehabilitation and to determine the effect of telerehabilitation on the quality of life, anxiety and depression levels of children with cerebral palsy and their caregivers. It will be compared to a control group that did not accept telerehabilitation but was recommended to exercise at home.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy, telerehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
telerehabilitation
Arm Type
Experimental
Arm Description
The exercises will be applied twice a week for a total of 12 weeks, and each program will last roughly 30 minutes.
Arm Title
control
Arm Type
Active Comparator
Arm Description
The same exercise program will be prepared and given as a printout and they will be asked to do their exercises at home. This group will also be included in the study as a control group.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Intervention Description
The exercise program will begin with a warm-up, followed by a stretching exercise and an alphabetical exercise game called what's your name, and will end with a cool-down. The exercises will be performed 2 times a week for a total of 12 weeks, and each program will last for roughly 30 minutes. it will last. In what is your name game, 10 5-letter words containing the whole alphabet were produced and children will work out the exercises corresponding to each letter with a word they choose for each day.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The same exercise program will be prepared and given to the patients who are offered and not accepted telerehabilitation, and they will be asked to do their own exercises at home. This group will also be included in the study as a control group.
Primary Outcome Measure Information:
Title
CP-QOL-Child ve Teen
Description
Evaluates the quality of life in Cerebral Palsy.
Time Frame
Day 0 - Day 90
Title
Revised Child Anxiety and Depression Scale
Description
It was developed to screen for anxiety disorders and depression.
Time Frame
Day 0 - Day 90
Title
STAI-State Trait Anxiety Inventory
Description
It is a self-evaluation questionnaire consisting of short statements.
Time Frame
Day 0 - Day 90
Title
BECK Depression Inventory
Description
It will be applied in determining depression levels.
Time Frame
Day 0 - Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Spastic Hemiplegic and Diplegic Cerebral Palsy in participating children confirmed by pediatric neurologists Being GMFCS I and II Spasticity value of 1, 2 or maximum 3 in the evaluation made with Modified Ashworth Scale (MAS) on lower extremity muscles Being able to stand and walk without using any auxiliary equipment Being mentally capable of reading the commands of the assessment. Agree to participate in the study Exclusion Criteria: Not having ambulation Having a cognitive disorder Having undergone any orthopedic surgery or spasticity replacement procedure in the past 12 months Having vision problems except refraction Having any known systemic problems Having an uncontrolled epileptic seizure Having lower extremity contracture that affects the evaluation The occurrence of any health problems that could affect the work Refusing to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evrim Karadag-Saygi, Prof. Dr.
Organizational Affiliation
Physical Medicine and Rehabilitation Department, School of Medicine, Marmara University, Istanbul
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ayca Evkaya Acar, Lecturer
Organizational Affiliation
Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul Medeniyet University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nurahsen Demir, Res. Asst.
Organizational Affiliation
Physical Medicine and Rehabilitation Department, School of Medicine, Marmara University, Istanbul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17370477
Citation
Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14. Erratum In: Dev Med Child Neurol. 2007 Jun;49(6):480.
Results Reference
background
PubMed Identifier
18929061
Citation
Berker AN, Yalcin MS. Cerebral palsy: orthopedic aspects and rehabilitation. Pediatr Clin North Am. 2008 Oct;55(5):1209-25, ix. doi: 10.1016/j.pcl.2008.07.011.
Results Reference
background
PubMed Identifier
15132254
Citation
Tilton AH. Management of spasticity in children with cerebral palsy. Semin Pediatr Neurol. 2004 Mar;11(1):58-65. doi: 10.1016/j.spen.2004.01.008.
Results Reference
background
PubMed Identifier
32206590
Citation
Patel DR, Neelakantan M, Pandher K, Merrick J. Cerebral palsy in children: a clinical overview. Transl Pediatr. 2020 Feb;9(Suppl 1):S125-S135. doi: 10.21037/tp.2020.01.01.
Results Reference
background
PubMed Identifier
14515936
Citation
McBurney H, Taylor NF, Dodd KJ, Graham HK. A qualitative analysis of the benefits of strength training for young people with cerebral palsy. Dev Med Child Neurol. 2003 Oct;45(10):658-63. doi: 10.1017/s0012162203001233.
Results Reference
background

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The Effect of Telerehabilitation on the Children With Cerebral Palsy and Their Caregivers

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