Cerebral PalsyNCT04896840
Tele-rehabilitation in Children With Cerebral Palsy in the Covid-19 Pandemic
A study testing Telerehabilitation İntervention, Motor learning in people with Cerebral Palsy and Telerehabilitation, run by Inonu University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Telerehabilitation, Motor Learning
- What is being tested?
- Telerehabilitation İntervention, Motor learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 27 Aug 2021to 27 Oct 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 3 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Application of muscle tone reduction 6 months before the start of the study (eg botulin toxin, baclofen pump therapy) or those undergoing orthopedic surgery.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Inonu University
Malatya, 44000
Engin Ramazanoglu, PhD student, 04223410220, enginramazanoglu@hotmail.com
Inonu University Health Sciences Institute, PhD student
- Recruiting
Inonu University
Malatya, 44000
burcu talu, associate professor, 04223410220, fzt.burcu@hotmail.com
About this study
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
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.
Read the 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.
- Conditions
- Cerebral Palsy, Telerehabilitation, Motor Learning
- Being tested
- Telerehabilitation İntervention, Motor learning
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation İntervention, Motor learningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Telerehabilitation and motor learning principles will be applied. Receives: Other: Telerehabilitation İntervention, Motor learning |
| Control Group | Experimental | Motor learning principles will be applied in the clinic. Receives: Other: Telerehabilitation İntervention, Motor learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start27 Aug 2021
- Primary completion27 Oct 2021
- Study completion27 Oct 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 Inonu 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engin Ramazanoglu, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896840
- Sponsor's protocol ID
- 2021/1422
- Status last verified
- Oct 2021
- First submitted
- 14 May 2021
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The information of the patients participating in the study will be kept confidential.
Publications
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.
PubMed 20576667Dunn 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.
PubMed 6138665Meijer 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.
PubMed 29138050Pastora-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.
PubMed 28455277Woollacott 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.
PubMed 16097489
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04896840
- Acronym / sponsor ID
- 2021/1422
- Conditions
- Cerebral Palsy, Telerehabilitation, Motor Learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 27 Oct 2021 (actual)
- Study completion
- 27 Oct 2021 (estimated)
- First posted
- 21 May 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Telerehabilitation İntervention, Motor learningTelerehabilitation and motor learning principles will be applied. |
| Control Group | Experimental | Other: Telerehabilitation İntervention, Motor learningMotor learning principles will be applied in the clinic. |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Application of muscle tone reduction 6 months before the start of the study (eg botulin toxin, baclofen pump therapy) or those undergoing orthopedic surgery.
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 |
|---|---|---|
| Telerehabilitation İntervention, Motor learningTelerehabilitation 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. | Other | Control Group, Treatment group |
Primary outcome
Pediatric Quality of Life Inventory
Time frame: 8 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Background: PubMed 20576667Bar-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.
- Background: PubMed 6138665Dunn 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.
- Background: PubMed 29138050Meijer 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.
- Background: PubMed 28455277Pastora-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.
- Background: PubMed 16097489Woollacott 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.
- Individual participant dataSharing planned: No. The information of the patients participating in the study will be kept confidential.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation İntervention, Motor learning in people with Cerebral Palsy and Telerehabilitation, run by Inonu University at 2 sites 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 4 inclusion and 1 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Quality of Life Inventory (time frame: 8 weeks). 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 NCT04896840, 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 1 Nov 2021.