Clinical trial NCT04923438: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: cerebral palsy
telerehabilitation
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 34
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: CP-QOL-Child ve Teen
timeFrame: Day 0 - Day 90
measure: Revised Child Anxiety and Depression Scale
timeFrame: Day 0 - Day 90
measure: STAI-State Trait Anxiety Inventory
timeFrame: Day 0 - Day 90
measure: BECK Depression Inventory
timeFrame: Day 0 - Day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Physical Medicine and Rehabilitation Department, School of Medicine, Marmara University, Istanbul
name: Evrim Karadag-Saygi, Prof. Dr.
role: STUDY_CHAIR
affiliation: Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul Medeniyet University
name: Ayca Evkaya Acar, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Physical Medicine and Rehabilitation Department, School of Medicine, Marmara University, Istanbul
name: Nurahsen Demir, Res. Asst.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.