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

Primary Purpose

Cerebral Palsy, Telerehabilitation, Motor Learning

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation İntervention, Motor learning
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

3 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Inonu UniversityRecruiting
  • Inonu UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment group

Control Group

Arm Description

Telerehabilitation and motor learning principles will be applied.

Motor learning principles will be applied in the clinic.

Outcomes

Primary Outcome Measures

Pediatric Quality of Life Inventory
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.

Secondary Outcome Measures

Full Information

First Posted
May 14, 2021
Last Updated
October 29, 2021
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT04896840
Brief Title
Tele-rehabilitation in Children With Cerebral Palsy in the Covid-19 Pandemic
Official Title
The Effect of Motor Learning Based Tele-rehabilitation on Quality of Life in Children With Cerebral Palsy During the Covid-19 Epidemic Process
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 27, 2021 (Actual)
Primary Completion Date
October 27, 2021 (Actual)
Study Completion Date
October 27, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Telerehabilitation, Motor Learning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Telerehabilitation and motor learning principles will be applied.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Motor learning principles will be applied in the clinic.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation İntervention, Motor learning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pediatric Quality of Life Inventory
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Inonu University
City
Malatya
ZIP/Postal Code
44000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Engin Ramazanoglu, PhD student
Phone
04223410220
Email
enginramazanoglu@hotmail.com
First Name & Middle Initial & Last Name & Degree
Inonu University Health Sciences Institute, PhD student
First Name & Middle Initial & Last Name & Degree
Rabia Çelikel, PhD student
Facility Name
Inonu University
City
Malatya
ZIP/Postal Code
44000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
burcu talu, associate professor
Phone
04223410220
Email
fzt.burcu@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The information of the patients participating in the study will be kept confidential.
Citations:
PubMed Identifier
20576667
Citation
Bar-Haim S, Harries N, Nammourah I, Oraibi S, Malhees W, Loeppky J, Perkins NJ, Belokopytov M, Kaplanski J, Lahat E; MERC project. Effectiveness of motor learning coaching in children with cerebral palsy: a randomized controlled trial. Clin Rehabil. 2010 Nov;24(11):1009-20. doi: 10.1177/0269215510371428. Epub 2010 Jun 24.
Results Reference
background
PubMed Identifier
6138665
Citation
Dunn AM, Patel KP. Integration of geriatric with general medical services. Lancet. 1983 Nov 12;2(8359):1139. doi: 10.1016/s0140-6736(83)90650-5. No abstract available.
Results Reference
background
PubMed Identifier
29138050
Citation
Meijer HA, Graafland M, Goslings JC, Schijven MP. Systematic Review on the Effects of Serious Games and Wearable Technology Used in Rehabilitation of Patients With Traumatic Bone and Soft Tissue Injuries. Arch Phys Med Rehabil. 2018 Sep;99(9):1890-1899. doi: 10.1016/j.apmr.2017.10.018. Epub 2017 Nov 11.
Results Reference
background
PubMed Identifier
28455277
Citation
Pastora-Bernal JM, Martin-Valero R, Baron-Lopez FJ, Estebanez-Perez MJ. Evidence of Benefit of Telerehabitation After Orthopedic Surgery: A Systematic Review. J Med Internet Res. 2017 Apr 28;19(4):e142. doi: 10.2196/jmir.6836.
Results Reference
background
PubMed Identifier
16097489
Citation
Woollacott MH, Shumway-Cook A. Postural dysfunction during standing and walking in children with cerebral palsy: what are the underlying problems and what new therapies might improve balance? Neural Plast. 2005;12(2-3):211-9; discussion 263-72. doi: 10.1155/NP.2005.211.
Results Reference
background

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

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