Cerebral PalsyNCT04923438
The Effect of Telerehabilitation on the Children With Cerebral Palsy and Their Caregivers
A study testing Telerehabilitation in people with Cerebral Palsy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2021to 26 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Istanbul, 34890
About this study
Official title: The Effect of Telerehabilitation on the Quality of Life, Anxiety and Depression Levels of Children With Cerebral Palsy and Their Caregivers
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.
Read more
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Telerehabilitation, Control
- Keywords
- cerebral palsy, telerehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| telerehabilitation | Experimental | The exercises will be applied twice a week for a total of 12 weeks, and each program will last roughly 30 minutes. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
CP-QOL-Child ve Teen
Evaluates the quality of life in Cerebral Palsy.
Measured: Day 0 - Day 90
Revised Child Anxiety and Depression Scale
It was developed to screen for anxiety disorders and depression.
Measured: Day 0 - Day 90
STAI-State Trait Anxiety Inventory
It is a self-evaluation questionnaire consisting of short statements.
Measured: Day 0 - Day 90
BECK Depression Inventory
It will be applied in determining depression levels.
Measured: Day 0 - Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start16 Feb 2021
- Primary completion12 Jun 2021 (estimated)
- Study completion26 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evrim Karadag-Saygi, Prof. Dr., Study chair, Physical Medicine and Rehabilitation Department, School of Medicine, Marmara University, IstanbulAyca Evkaya Acar, Lecturer, Principal investigator, Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul Medeniyet UniversityNurahsen Demir, Res. Asst., Principal investigator, Physical Medicine and Rehabilitation Department, School of Medicine, Marmara University, Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923438
- Sponsor's protocol ID
- 09.2021.180
- Status last verified
- Jun 2021
- First submitted
- 6 Jun 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17370477Berker 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.
PubMed 18929061Tilton 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.
PubMed 15132254Patel 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.
PubMed 32206590McBurney 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.
PubMed 14515936
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Telerehabilitation on the Quality of Life, Anxiety and Depression Levels of Children With Cerebral Palsy and Their Caregivers
- ClinicalTrials.gov ID
- NCT04923438
- Acronym / sponsor ID
- 09.2021.180
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 12 Jun 2021 (estimated)
- Study completion
- 26 Jun 2021 (estimated)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telerehabilitation | Experimental | Other: TelerehabilitationThe exercises will be applied twice a week for a total of 12 weeks, and each program will last roughly 30 minutes. |
| control | Active comparator | Other: ControlThe 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitationThe 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. | Other | telerehabilitation |
| ControlThe 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. | Other | control |
Primary outcome
CP-QOL-Child ve Teen
Time frame: Day 0 - Day 90
Evaluates the quality of life in Cerebral Palsy.
Revised Child Anxiety and Depression Scale
Time frame: Day 0 - Day 90
It was developed to screen for anxiety disorders and depression.
STAI-State Trait Anxiety Inventory
Time frame: Day 0 - Day 90
It is a self-evaluation questionnaire consisting of short statements.
BECK Depression Inventory
Time frame: Day 0 - Day 90
It will be applied in determining depression levels.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Background: PubMed 17370477Rosenbaum 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.
- Background: PubMed 18929061Berker 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.
- Background: PubMed 15132254Tilton 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.
- Background: PubMed 32206590Patel 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.
- Background: PubMed 14515936McBurney 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evrim Karadag-Saygi, Prof. Dr. study chair
Physical Medicine and Rehabilitation Department, School of Medicine, Marmara University, Istanbul
Ayca Evkaya Acar, Lecturer principal investigator
Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul Medeniyet University
Nurahsen Demir, Res. Asst. principal investigator
Physical Medicine and Rehabilitation Department, School of Medicine, Marmara University, Istanbul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation in people with Cerebral Palsy, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CP-QOL-Child ve Teen (time frame: Day 0 - Day 90). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04923438, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.