- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04900402
Activity Level and Quality of Life of Individuals With Physical Disabilities
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey
- Sağlık Bilimleri Üniversitesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
International Physical Activity Questionnaire Short Form (IPAQ) and Quality of Life Scale for Children (PedsQL)
|
|
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.
|
International Physical Activity Questionnaire Short Form (IPAQ) and Quality of Life Scale for Children (PedsQL)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of activity level
Time Frame: Baseline
|
Measurement of activity level with International Physical Activity Questionnaire Short Form (IPAQ)
|
Baseline
|
|
Evaluation of quality of life
Time Frame: Baseline
|
Measurement of quality of life with Children's Quality of Life Scale (PedsQL)
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fulya Senem KARAAHMETOĞLU, Sağlık Bilimleri University
- Study Director: Esra PEHLİVAN, Assoc. Prof., Sağlık Bilimleri University
- Principal Investigator: Zeynep Betül ÖZCAN, Sağlık Bilimleri University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- continue_rehabilitation
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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