Cerebral PalsyNCT06443398
Spine of Caregivers of Children with Cerebral Palsy
An observational study of Cerebral Palsy and Spine Deformity, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to assess pain (rest, activity, and night pain using the Visual Analog Scale), disability (neck using the Neck Disability Index; lumbar using the Oswestry Disability Index), and curvature (cervical, thoracic, and lumbar using the Spinal Mouse) in primary caregivers of children with… Read more about this study
- Who is it for?
- Ages 25 to 54 years
- Conditions the study is for
- Cerebral Palsy, Spine Deformity
- How many people
- 164 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jan 2024to 25 Sep 2024
- Phase
- Observational
- 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 25 to 54 years
- All sexes
- No healthy volunteers
- Adult
Study population: It was conducted with caregivers of children with Cerebral Palsy who were receiving physiotherapy at Kırşehir Training and Research Hospital Physical Therapy and Rehabilitation Center and who met the exclusion-inclusion criteria.
Who may be able to join
- Primary caregiver between the ages of 25-54
- Has a child diagnosed with Cerebral Palsy between the ages of 0-18
- Does not have inflammatory pain
- Without pain originating from abdominal-pelvic organs
- Volunteer caregivers were included
Who cannot join
- Having acute fracture and malignancy
- Had a surgical operation (related to spine disorders)
- Having a care burden for more than one disabled individual
- Caregivers with chronic illnesses (such as neurological, psychological disorders) were excluded
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center
Kırşehir
About this study
Official title: Evaluation of the Spine of Primary Caregivers of Children with Cerebral Palsy
The purpose of this study was to assess pain (rest, activity, and night pain using the Visual Analog Scale), disability (neck using the Neck Disability Index; lumbar using the Oswestry Disability Index), and curvature (cervical, thoracic, and lumbar using the Spinal Mouse) in primary caregivers of children with cerebral palsy.
- Conditions
- Cerebral Palsy, Spine Deformity
- Being tested
- There is no intervention in the study
- Keywords
- Primary Caregivers, Pain, Disability
- Medical subject headings
- Cerebral Palsy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention in the studyOther
There is no intervention in the study
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Primary caregivers with healthy children between the ages of 0-18 were included. Receives: Other: There is no intervention in the study | |
| Study Group | Primary caregivers who had a child diagnosed with Cerebral Palsy between the ages of 0-18 and met the inclusion criteria were included. Receives: Other: There is no intervention in the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life Quality
Parents' quality of life was measured using the Nottingham Health Profile. The scale has two parts. 0 represents the best health status, 100 the worst. Score on the scale and health status have an inverse relationship. As the score increases, the health status deteriorates.
Measured: 16 week
Disability
Functional problems related to the neck were assessed using the Neck Disability Index. The scale has 10 items. There are 6 options in each item and each option is scored between 0 and 5 depending on the severity of the limitation. Although the total score of the survey varies between 0 and 50, a higher score indicates an increase in limitation.
Measured: 16 week
Disability
Oswestry Disability Index was used to determine the degree of disability. The scale consists of a total of 10 items measuring the severity of pain, personal care, lifting, walking, sitting, standing, social life, sleeping, travel and pain degree. Each item is rated between 0-5. As the total score increases, the disability level increases. The maximum score is 50 points; Between 31 and 50 points is considered severe, between 11 and 30 points is considered moderate, and between 1 and 10 points is considered mild.
Measured: 16 week
Spine
Spine evaluation was performed with a spinal mouse device. The device is a computer-aided electromagnetic device that can be held by hand and used to measure spinal mobility in various postures.
Measured: 16 week
Secondary outcomes (3)
Socio-demographic Form
Sociodemographic information of the caregivers, such as name, surname, age, gender, height, weight, BMI, and educational status, were recorded.
Measured: 16 week
Pain Intensity
The pain intensity of the patients was measured using the Visual Analogue Scale. The pain intensity score ranges from 0 to 10. An increase in the score indicates an increase in pain; a decrease in the score indicates a decrease in pain.
Measured: 16 week
Gross Motor Function Classification
Gross Motor Function Classification System (Children with Cerebral Palsy are classified in 5 levels (1-5) according to their motor skills, functional abilities, assistive technology and wheelchair requirements)
Measured: 16 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start31 Jan 2024
- Primary completion20 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atahan TURHAN, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443398
- Sponsor's protocol ID
- KAEU-T.ATAHAN-005
- Status last verified
- May 2024
- First submitted
- 30 May 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Spine of Primary Caregivers of Children with Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06443398
- Acronym / sponsor ID
- KAEU-T.ATAHAN-005
- Conditions
- Cerebral Palsy, Spine Deformity
- Keywords
- Primary Caregivers, Pain, Disability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 5 Jun 2024 (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 purpose of this study was to assess pain (rest, activity, and night pain using the Visual Analog Scale), disability (neck using the Neck Disability Index; lumbar using the Oswestry Disability Index), and curvature (cervical, thoracic, and lumbar using the Spinal Mouse) in primary caregivers of children with cerebral palsy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Other: There is no intervention in the studyPrimary caregivers with healthy children between the ages of 0-18 were included. |
| Study Group | – | Other: There is no intervention in the studyPrimary caregivers who had a child diagnosed with Cerebral Palsy between the ages of 0-18 and met the inclusion criteria were included. |
Who may qualify
- Ages
- 25 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- It was conducted with caregivers of children with Cerebral Palsy who were receiving physiotherapy at Kırşehir Training and Research Hospital Physical Therapy and Rehabilitation Center and who met the exclusion-inclusion criteria.
Key inclusion criteria (5 listed)
- Primary caregiver between the ages of 25-54
- Has a child diagnosed with Cerebral Palsy between the ages of 0-18
- Does not have inflammatory pain
- Without pain originating from abdominal-pelvic organs
- Volunteer caregivers were included
Key exclusion criteria (4 listed)
- Having acute fracture and malignancy
- Had a surgical operation (related to spine disorders)
- Having a care burden for more than one disabled individual
- Caregivers with chronic illnesses (such as neurological, psychological disorders) were excluded
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 |
|---|---|---|
| There is no intervention in the studyThere is no intervention in the study | Other | Control Group, Study Group |
Primary outcome
Life Quality
Time frame: 16 week
Parents' quality of life was measured using the Nottingham Health Profile. The scale has two parts. 0 represents the best health status, 100 the worst. Score on the scale and health status have an inverse relationship. As the score increases, the health status deteriorates.
Disability
Time frame: 16 week
Functional problems related to the neck were assessed using the Neck Disability Index. The scale has 10 items. There are 6 options in each item and each option is scored between 0 and 5 depending on the severity of the limitation. Although the total score of the survey varies between 0 and 50, a higher score indicates an increase in limitation.
Disability
Time frame: 16 week
Oswestry Disability Index was used to determine the degree of disability. The scale consists of a total of 10 items measuring the severity of pain, personal care, lifting, walking, sitting, standing, social life, sleeping, travel and pain degree. Each item is rated between 0-5. As the total score increases, the disability level increases. The maximum score is 50 points; Between 31 and 50 points is considered severe, between 11 and 30 points is considered moderate, and between 1 and 10 points is considered mild.
Spine
Time frame: 16 week
Spine evaluation was performed with a spinal mouse device. The device is a computer-aided electromagnetic device that can be held by hand and used to measure spinal mobility in various postures.
3 secondary outcomes
Socio-demographic Form
Time frame: 16 week
Pain Intensity
Time frame: 16 week
Gross Motor Function Classification
Time frame: 16 week
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 1 Oct 2024.
- 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?
An observational study of Cerebral Palsy and Spine Deformity, run by Kirsehir Ahi Evran Universitesi 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 5 inclusion and 4 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 1 Oct 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?
Life Quality (time frame: 16 week). 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?
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 Oct 2024.