Cerebral Palsy(EoTBHPCP)NCT04807790
Effects of "Telerehabılıtatıon Based Structured Home Program Implementatıons" Chıldren With Cerebral Palsy
A study testing Telerehabilitation based structured home program applications in people with Cerebral Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to examine the effectiveness of Telerehabilitation Based Structured Home Program Implementations on functional status, activity and participation in preschool children with Cerebral Palsy. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Telerehabilitation based structured home program applications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2021to 31 Mar 2023
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being in preschool period (3-5 years old)
- Receiving routine physiotherapy and rehabilitation services 2 sessions in a week
- Family members being active mobile phone or computer and internet users
Who cannot join
- Uncontrolled epileptic seizures
- Incomplete assesments
- Family's discontinuation of treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of "Telerehabılıtatıon Based Structured Home Program Implementatıons" For The Improvement Of Motor Functıon, Activity And Participation In Pre-Schooler Chıldren With Cerebral Palsy
The aim of the study is to examine the effectiveness of Telerehabilitation Based Structured Home Program Implementations on functional status, activity and participation in preschool children with Cerebral Palsy.
Read the detailed description
The structured home program will consist of activities determined by the family members according to the functional level of the child and the activities child can't do, and which are determined according to the goals specific to the child. In order to ensure that the structured home program created can be implemented by the family, a 1 hour family training will be provided.
After the structured home program training, a 45-minute video interview will be held with one of the family members (mother-father-caregiver) once a week, in order to check by the physiotherapist whether the home program is implemented correctly. Video interviews will be the telerehabilitation part of the study.
During routine physiotherapy and rehabilitation practices, activities organized by physiotherapists as one or two sessions per week according to the functional levels of children with CP. Routine physiotherapy and rehabilitation applications include increasing postural control, gaining motor development steps, strengthening training, balance training, long-term stretching training, manual therapy, hydrotherapy, hippotherapy and neurodevelopmental therapy approaches. Telerehabilitation-based structured home program applications, which are given in addition to routine physiotherapy and rehabilitation applications, and only individuals who receive routine physiotherapy and rehabilitation will be followed for 24 weeks. Individuals who receive routine physiotherapy and rehabilitation will be monitored only for control purposes, and a structured home program will be given to the group that receives Telerehabilitation Based Structured Home Program Practices, which are given in addition to routine physiotherapy and rehabilitation applications. The researcher will not be included in the program of the group that only benefits from routine physiotherapy and rehabilitation practices. A total of three evaluations will be made for both groups, after the training before the training and after 12 weeks from the training.
- Conditions
- Cerebral Palsy
- Being tested
- Telerehabilitation based structured home program applications
- Keywords
- telerehabilitation, cerebral palsy, home program, participation, activity
- Medical subject headings
- Cerebral Palsy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation based structured home program applicationsOther
Also called Routine physiotherapy and rehabilitation group
The structured home program will consist of activities determined by the family members according to the functional level of the child and the activities he / she can not do, and which are determined according to the goals specific to the child. In order to ensure that the structured home program created can be implemented by the family, a 1 hour family training will be provided.
After the structured home program training, a 45-minute video interview will be held with one of the family members (mother-father-caregiver) once a week, in order to check by the physiotherapist whether the home program is implemented correctly. Video interviews will be the telerehabilitation part of the study.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation based structured home program group | Experimental | The structured home program will consist of activities determined by the family members according to the functional level of the child and the activities he / she can not do, and which are determined according to the goals specific to the child. In order to ensure that the structured home program created can be implemented by the family, a 1 hour family training will be provided.
After the structured home program training, a 45-minute video interview will be held with one of the family members (mother-father-caregiver) once a week, in order to check by the physiotherapist whether the home program is implemented correctly. Video interviews will be the telerehabilitation part of the study. Receives: Other: Telerehabilitation based structured home program applications |
| Routine physiotherapy and rehabilitation group | No intervention | Routine physiotherapy and rehabilitation practices, consist of activities organized by physiotherapists as one or two sessions per week according to the functional levels of children with CP. Routine physiotherapy and rehabilitation applications include increasing postural control, gaining motor development steps, strengthening training, balance training, long-term stretching training, manual therapy, hydrotherapy, hippotherapy and neurodevelopmental therapy approaches. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure-88 (GMFM-88)
GMFM-66 is a widely used scale to show the improvement in motor function. The KMFM-88 evaluates the motor functional structure in five main positions: supine and prone lying and rolling (A), sitting (B), crawling and kneeling (C), standing (D), walking, running and jumping (E). The highest score is 100, the lowest score is 0.
Measured: At baseline
Quality of Upper Extremity Skills Test (QUEST)
It is used to evaluate the upper extremity motor functions of children. QUEST is a test that evaluates the quality of movement and dexterity of the child with SP. QUEST is concerned with how the child does the activity he or she can do. Examines the quality of upper limb skills in 7 sections. The highest score is 100, the lowest score is 50.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start10 Feb 2021
- Primary completion10 Mar 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Hacettepe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mintaze Kerem Gunel, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807790
- Sponsor's protocol ID
- KA- 20124
- Acronym
- (EoTBHPCP)
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2021
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sel SA, Gunel MK, Erdem S, Tuncdemir M. Effects of Telerehabilitation-Based Structured Home Program on Activity, Participation and Goal Achievement in Preschool Children with Cerebral Palsy: A Triple-Blinded Randomized Controlled Trial. Children (Basel). 2023 Feb 22;10(3):424. doi: 10.3390/children10030424.
PubMed 36979982
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of "Telerehabılıtatıon Based Structured Home Program Implementatıons" For The Improvement Of Motor Functıon, Activity And Participation In Pre-Schooler Chıldren With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04807790
- Acronym / sponsor ID
- (EoTBHPCP) / KA- 20124
- Conditions
- Cerebral Palsy
- Keywords
- telerehabilitation, cerebral palsy, home program, participation, activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 19 Mar 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 aim of the study is to examine the effectiveness of Telerehabilitation Based Structured Home Program Implementations on functional status, activity and participation in preschool children with Cerebral Palsy.
Detailed description
The structured home program will consist of activities determined by the family members according to the functional level of the child and the activities child can't do, and which are determined according to the goals specific to the child. In order to ensure that the structured home program created can be implemented by the family, a 1 hour family training will be provided.
After the structured home program training, a 45-minute video interview will be held with one of the family members (mother-father-caregiver) once a week, in order to check by the physiotherapist whether the home program is implemented correctly. Video interviews will be the telerehabilitation part of the study.
During routine physiotherapy and rehabilitation practices, activities organized by physiotherapists as one or two sessions per week according to the functional levels of children with CP. Routine physiotherapy and rehabilitation applications include increasing postural control, gaining motor development steps, strengthening training, balance training, long-term stretching training, manual therapy, hydrotherapy, hippotherapy and neurodevelopmental therapy approaches. Telerehabilitation-based structured home program applications, which are given in addition to routine physiotherapy and rehabilitation applications, and only individuals who receive routine physiotherapy and rehabilitation will be followed for 24 weeks. Individuals who receive routine physiotherapy and rehabilitation will be monitored only for control purposes, and a structured home program will be given to the group that receives Telerehabilitation Based Structured Home Program Practices, which are given in addition to routine physiotherapy and rehabilitation applications. The researcher will not be included in the program of the group that only benefits from routine physiotherapy and rehabilitation practices. A total of three evaluations will be made for both groups, after the training before the training and after 12 weeks from the training.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation based structured home program group | Experimental | Other: Telerehabilitation based structured home program applicationsThe structured home program will consist of activities determined by the family members according to the functional level of the child and the activities he / she can not do, and which are determined according to the goals specific to the child. In order to ensure that the structured home program created can be implemented by the family, a 1 hour family training will be provided. After the structured home program training, a 45-minute video interview will be held with one of the family members (mother-father-caregiver) once a week, in order to check by the physiotherapist whether the home program is implemented correctly. Video interviews will be the telerehabilitation part of the study. |
| Routine physiotherapy and rehabilitation group | No intervention | –Routine physiotherapy and rehabilitation practices, consist of activities organized by physiotherapists as one or two sessions per week according to the functional levels of children with CP. Routine physiotherapy and rehabilitation applications include increasing postural control, gaining motor development steps, strengthening training, balance training, long-term stretching training, manual therapy, hydrotherapy, hippotherapy and neurodevelopmental therapy approaches. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Being in preschool period (3-5 years old)
- Receiving routine physiotherapy and rehabilitation services 2 sessions in a week
- Family members being active mobile phone or computer and internet users
Key exclusion criteria (3 listed)
- Uncontrolled epileptic seizures
- Incomplete assesments
- Family's discontinuation of treatment
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 based structured home program applicationsAlso: Routine physiotherapy and rehabilitation groupThe structured home program will consist of activities determined by the family members according to the functional level of the child and the activities he / she can not do, and which are determined according to the goals specific to the child. In order to ensure that the structured home program created can be implemented by the family, a 1 hour family training will be provided. After the structured home program training, a 45-minute video interview will be held with one of the family members (mother-father-caregiver) once a week, in order to check by the physiotherapist whether the home program is implemented correctly. Video interviews will be the telerehabilitation part of the study. | Other | Telerehabilitation based structured home program group |
Primary outcome
Gross Motor Function Measure-88 (GMFM-88)
Time frame: At baseline
GMFM-66 is a widely used scale to show the improvement in motor function. The KMFM-88 evaluates the motor functional structure in five main positions: supine and prone lying and rolling (A), sitting (B), crawling and kneeling (C), standing (D), walking, running and jumping (E). The highest score is 100, the lowest score is 0.
Quality of Upper Extremity Skills Test (QUEST)
Time frame: At baseline
It is used to evaluate the upper extremity motor functions of children. QUEST is a test that evaluates the quality of movement and dexterity of the child with SP. QUEST is concerned with how the child does the activity he or she can do. Examines the quality of upper limb skills in 7 sections. The highest score is 100, the lowest score is 50.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 36979982Sel SA, Gunel MK, Erdem S, Tuncdemir M. Effects of Telerehabilitation-Based Structured Home Program on Activity, Participation and Goal Achievement in Preschool Children with Cerebral Palsy: A Triple-Blinded Randomized Controlled Trial. Children (Basel). 2023 Feb 22;10(3):424. doi: 10.3390/children10030424.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 based structured home program applications in people with Cerebral Palsy, run by Hacettepe 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 30 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gross Motor Function Measure-88 (GMFM-88) (time frame: At baseline). The study lists 2 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 NCT04807790, which also lists 1 linked publication.
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 30 Jul 2024.