Covid19NCT04900402
Activity Level and Quality of Life of Individuals With Physical Disabilities
An observational study of Covid19 and Physical Disability, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study; It will be done in order to compare the quality of life and physical activity levels of physically disabled individuals who continue and do not continue rehabilitation during COVID-19. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Covid19, Physical Disability, Quality of Life
- What is being tested?
- Survey
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 May 2021to 2 Oct 2021
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with physical disabilities (cerebral palsy, spina bifida, down syndrome etc.)
Who may be able to join
- The consent form informed by their parents was read and signed, Children with physical disabilities between the ages of 2 and 18 (cerebral palsy, spina bifida, down syndrome)
- Level I, II and III, IV and V according to KMFSS,
- The person (child or parent) answering the questionnaire is literate in Turkish,
- Children without mental impairment or with mild and moderate mental impairment will be included, according to the "disabled health committee report" of the hospitals.
Who cannot join
- Cases who have undergone any surgical operation affecting the trunk and upper extremity and lower extremity in the last six months.
- Children with severe mental impairment will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Activity Level and Quality of Life of Individuals With Physical Disabilities, Those Who Continue and do Not Continue Rehabilitation During COVID-19
This study; It will be done in order to compare the quality of life and physical activity levels of physically disabled individuals who continue and do not continue rehabilitation during COVID-19. International Physical Activity Questionnaire Short Form (IPAQ) and The Quality of Life Scale for Children (PedsQL) questionnaire will be applied.
Read the detailed description
Studies on COVID-19, which is spreading rapidly all over the world, show that the pediatric population is less affected than the adult and elderly population. Respiratory complications are the leading cause of death in the chronic neuropediatric population. During the pandemic, rehabilitation staff such as physiotherapists are at risk of transmission and therefore their activities should be suspended. For this reason, a 3-month quarantine was applied for individuals who went to special education and rehabilitation in our country from March 2020 to June 2020, and face-to-face sessions could not be continued in rehabilitation.
The negative effects of social isolation in children and adolescents during the pandemic affect mental and physical health. Studies show the importance of physical rehabilitation for pediatric patients with chronic neurological disorders. Rehabilitation is not continuous; It may cause soft tissue contractures, bone deformities, decline in motor functions, dysphagia and respiratory difficulties, among other complications. Pediatric patients with neurological disorders may also experience decline in motor function. Although it is known that rehabilitation services have started again with the strict implementation of social distance and hygiene rules in our country as of June 2020; while some of the physically disabled individuals continue their rehabilitation, those who do not continue with rehabilitation are at a considerable level. Therefore, our study; it will be made in order to compare the quality of life and physical activity levels of physically disabled individuals who continue and do not continue rehabilitation during COVID-19.
Following the approval of the ethics committee, a questionnaire will be applied to 18 children with physical disabilities who continue rehabilitation and 18 children with physical disabilities but who do not continue rehabilitation during COVID-19. The study will start with the approval of the ethics committee and is planned to be completed in October 2021, within 6 months.
The gross motor levels of the children who meet the inclusion criteria and whose families voluntarily accept to participate in the study are determined according to KMFSS, International Physical Activity Questionnaire Short Form (IPAQ) and Quality of Life Scale for Children (PedsQL) questionnaires will be applied to both children who continue special education and rehabilitation during COVID-19 and children who are not.
- Conditions
- Covid19, Physical Disability, Quality of Life
- Being tested
- Survey
- Keywords
- COVİD-19, Activity level, Physical Disabilities, Quality of Life
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
International Physical Activity Questionnaire Short Form (IPAQ) and Quality of Life Scale for Children (PedsQL)
| Study group | Role | What they receive |
|---|---|---|
| Individuals with physical disabilities continuing rehabilitation after COVID-19 | International Physical Activity Questionnaire Short Form (IPAQ) and Child Quality of Life Scale (PedsQL) questionnaires will be applied to individuals who continue their rehabilitation after the COVID-19 pandemic is declared. Receives: Other: Survey | |
| Individuals with physical disabilities not continuing rehabilitation after COVID-19 | International Physical Activity Questionnaire Short Form (IPAQ) and Child Quality of Life Scale (PedsQL) questionnaires will be applied to individuals who do not continue rehabilitation after the COVID-19 pandemic is declared. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of activity level
Measurement of activity level with International Physical Activity Questionnaire Short Form (IPAQ)
Measured: Baseline
Evaluation of quality of life
Measurement of quality of life with Children's Quality of Life Scale (PedsQL)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start18 May 2021
- Primary completion18 Jul 2021
- Study completion2 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Saglik Bilimleri 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulya Senem Karaahmetoglu, Saglik Bilimleri Universitesi
- Investigators
- Fulya Senem KARAAHMETOĞLU, Principal investigator, Saglik Bilimleri UniversitesiEsra PEHLİVAN, Assoc. Prof., Study director, Saglik Bilimleri UniversitesiZeynep Betül ÖZCAN, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900402
- Sponsor's protocol ID
- continue_rehabilitation
- Status last verified
- Dec 2021
- First submitted
- 11 May 2021
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Activity Level and Quality of Life of Individuals With Physical Disabilities, Those Who Continue and do Not Continue Rehabilitation During COVID-19
- ClinicalTrials.gov ID
- NCT04900402
- Acronym / sponsor ID
- continue_rehabilitation
- Conditions
- Covid19, Physical Disability, Quality of Life
- Keywords
- COVİD-19, Activity level, Physical Disabilities, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 18 Jul 2021 (actual)
- Study completion
- 2 Oct 2021 (actual)
- First posted
- 25 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.
This study; It will be done in order to compare the quality of life and physical activity levels of physically disabled individuals who continue and do not continue rehabilitation during COVID-19. International Physical Activity Questionnaire Short Form (IPAQ) and The Quality of Life Scale for Children (PedsQL) questionnaire will be applied.
Detailed description
Studies on COVID-19, which is spreading rapidly all over the world, show that the pediatric population is less affected than the adult and elderly population. Respiratory complications are the leading cause of death in the chronic neuropediatric population. During the pandemic, rehabilitation staff such as physiotherapists are at risk of transmission and therefore their activities should be suspended. For this reason, a 3-month quarantine was applied for individuals who went to special education and rehabilitation in our country from March 2020 to June 2020, and face-to-face sessions could not be continued in rehabilitation.
The negative effects of social isolation in children and adolescents during the pandemic affect mental and physical health. Studies show the importance of physical rehabilitation for pediatric patients with chronic neurological disorders. Rehabilitation is not continuous; It may cause soft tissue contractures, bone deformities, decline in motor functions, dysphagia and respiratory difficulties, among other complications. Pediatric patients with neurological disorders may also experience decline in motor function. Although it is known that rehabilitation services have started again with the strict implementation of social distance and hygiene rules in our country as of June 2020; while some of the physically disabled individuals continue their rehabilitation, those who do not continue with rehabilitation are at a considerable level. Therefore, our study; it will be made in order to compare the quality of life and physical activity levels of physically disabled individuals who continue and do not continue rehabilitation during COVID-19.
Following the approval of the ethics committee, a questionnaire will be applied to 18 children with physical disabilities who continue rehabilitation and 18 children with physical disabilities but who do not continue rehabilitation during COVID-19. The study will start with the approval of the ethics committee and is planned to be completed in October 2021, within 6 months.
The gross motor levels of the children who meet the inclusion criteria and whose families voluntarily accept to participate in the study are determined according to KMFSS, International Physical Activity Questionnaire Short Form (IPAQ) and Quality of Life Scale for Children (PedsQL) questionnaires will be applied to both children who continue special education and rehabilitation during COVID-19 and children who are not.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with physical disabilities continuing rehabilitation after COVID-19 | – | Other: SurveyInternational Physical Activity Questionnaire Short Form (IPAQ) and Child Quality of Life Scale (PedsQL) questionnaires will be applied to individuals who continue their rehabilitation after the COVID-19 pandemic is declared. |
| Individuals with physical disabilities not continuing rehabilitation after COVID-19 | – | Other: SurveyInternational Physical Activity Questionnaire Short Form (IPAQ) and Child Quality of Life Scale (PedsQL) questionnaires will be applied to individuals who do not continue rehabilitation after the COVID-19 pandemic is declared. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with physical disabilities (cerebral palsy, spina bifida, down syndrome etc.)
Key inclusion criteria (4 listed)
- The consent form informed by their parents was read and signed, Children with physical disabilities between the ages of 2 and 18 (cerebral palsy, spina bifida, down syndrome)
- Level I, II and III, IV and V according to KMFSS,
- The person (child or parent) answering the questionnaire is literate in Turkish,
- Children without mental impairment or with mild and moderate mental impairment will be included, according to the "disabled health committee report" of the hospitals.
Key exclusion criteria (2 listed)
- Cases who have undergone any surgical operation affecting the trunk and upper extremity and lower extremity in the last six months.
- Children with severe mental impairment will not be included.
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 |
|---|---|---|
| SurveyInternational Physical Activity Questionnaire Short Form (IPAQ) and Quality of Life Scale for Children (PedsQL) | Other | Individuals with physical disabilities continuing rehabilitation after COVID-19, Individuals with physical disabilities not continuing rehabilitation after COVID-19 |
Primary outcome
Evaluation of activity level
Time frame: Baseline
Measurement of activity level with International Physical Activity Questionnaire Short Form (IPAQ)
Evaluation of quality of life
Time frame: Baseline
Measurement of quality of life with Children's Quality of Life Scale (PedsQL)
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 28 Dec 2021.
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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.
Fulya Senem KARAAHMETOĞLU principal investigator
Saglik Bilimleri Universitesi
Esra PEHLİVAN, Assoc. Prof. study director
Saglik Bilimleri Universitesi
Zeynep Betül ÖZCAN principal investigator
Saglik Bilimleri Universitesi
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 Covid19 and Physical Disability, run by Saglik Bilimleri 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 4 inclusion and 2 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 28 Dec 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?
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?
Evaluation of activity level (time frame: 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?
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 28 Dec 2021.