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Pediatric Glittre ADL-test in Children With Asthma

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ClinicalTrials.gov Identifier: NCT03985956
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Muserrefe Nur Keles, Gazi University

Tracking Information
First Submitted Date June 11, 2019
First Posted Date June 14, 2019
Last Update Posted Date June 18, 2019
Actual Study Start Date June 1, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 11, 2019)
Glittre ADL test [ Time Frame: 15 minutes ]
Functional test
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03985956 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 11, 2019)
Six Minute Walk Test [ Time Frame: 10 mimutes ]
Exercise Test
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pediatric Glittre ADL-test in Children With Asthma
Official Title The Validity and Reliability of the ADL-Glittre Test as a Measure of Functional Capacity in Children With Asthma
Brief Summary The aim of the study is to investigate reliability, validity, of the Glittre ADL Test in children with Asthma.
Detailed Description The TGlittre-P is an adaptation of the TGlittre test for pediatric patients. It consists of completing a circuit while carrying a backpack with a variable weight of 0.5 kg to 2.5 kg, according to the child´s age and sex. This weight range follows the guidelines of the World Health Organization, which states that the younger the female child is, the lighter the backpack should be, in order to assure the school children´s health condition. The following tasks should be carried out; from a sitting position, the child stands up and walks along a 10m-long flat course, going up and down a 2-step rise (17 cm high x 27 cm wide) about halfway along that distance, to reach a bookshelf with three 0.5 kg objects (i.e. colorful plastic bowling pins filled with sand). The objects are placed on the top shelf at eye level, which should be removed, one by one, to the lower shelf at the level of the umbilicus, and then to the ground. Next, the objects should be placed on the lower shelf and then back to the top shelf. The child walks back along the same route. (S)he sits down, stands up and immediately starts the next lap. The following verbal instructions are given during the test: "sit" and "stand." The time required to walk five laps is registered; the less the time spent, the better the performance is. The test performance was evaluated by comparing the patient´s data with the data predicted by the equation, in his study with healthy children. The equation for girls is "time in TGlittre-P = 3.781-0.083 x AGE"; and boys, "time in TGlittre-P = 4.025-0.123 x AGE".
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Children with asthma who apply to Gazi University, Department of Physiotherapy and Rehabilitation will be invited to this study.
Condition Asthma in Children
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 11, 2019)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 10, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Children and adolescents aged 6-14 years with a diagnosis of Asthma
  • Task-oriented and co-operative patients without any musculoskeletal, rheumatic, neurological, hearing and visual diseases and without pulmonary exacerbation at the time of data collection will be included in this study.

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 14 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Müşerrefe N Keleş, PhD 03122162643 muserref-1@hotmail.com
Contact: Bulent Elbasan bulentelbasan@gmail.com
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03985956
Other Study ID Numbers 13579
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Muserrefe Nur Keles, Gazi University
Study Sponsor Gazi University
Collaborators Not Provided
Investigators
Principal Investigator: Müşerrefe N Keleş Gazi University
PRS Account Gazi University
Verification Date June 2019