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

NCT04923438 | Unknown

• 1 other identifier: 09.2021.180
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

cerebral palsy; telerehabilitation

Outcome Measures

Primary Outcomes (4)

• CP-QOL-Child ve Teen

  Evaluates the quality of life in Cerebral Palsy.

  Day 0 - Day 90

• Revised Child Anxiety and Depression Scale

  It was developed to screen for anxiety disorders and depression.

  Day 0 - Day 90

• STAI-State Trait Anxiety Inventory

  It is a self-evaluation questionnaire consisting of short statements.

  Day 0 - Day 90

• BECK Depression Inventory

  It will be applied in determining depression levels.

  Day 0 - Day 90

Study Arms (2)

telerehabilitation

EXPERIMENTAL

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

Other: Telerehabilitation

control

ACTIVE COMPARATOR

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.

Other: Control

Interventions

Telerehabilitation OTHER

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.

telerehabilitation

Control OTHER

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.

control

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, 34890, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 17370477 BACKGROUND

• 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.

  PMID: 18929061 BACKGROUND

• 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.

  PMID: 15132254 BACKGROUND

• 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.

  PMID: 32206590 BACKGROUND

• 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.

  PMID: 14515936 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Evrim Karadag-Saygi, Prof. Dr.

  Physical Medicine and Rehabilitation Department, School of Medicine, Marmara University, Istanbul

  STUDY CHAIR

• Ayca Evkaya Acar, Lecturer

  Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul Medeniyet University

  PRINCIPAL INVESTIGATOR

• Nurahsen Demir, Res. Asst.

  Physical Medicine and Rehabilitation Department, School of Medicine, Marmara University, Istanbul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 11, 2021
• Study Start: February 16, 2021
• Primary Completion: June 12, 2021
• Study Completion: June 26, 2021
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)