Hemophilia B Clinical Trial
Official title:
The Validity and Reliability of the Turkish Version of the "Pediatric Haemophilia Activities List - Short - PedHALshort" Questionnaire
This study aimed to establish the validity and reliability of the Turkish version of the Pediatric Haemophilia Activities List (short - PedHALshort) questionnaire.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | December 30, 2023 |
Est. primary completion date | August 30, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 4 Years to 17 Years |
Eligibility | Inclusion Criteria: - Having been diagnosed with Hemophilia by a physician (Factor VIII-IX) - Ages 4-17 years old - Receiving regular prophylactic treatment - Children who volunteered to participate in the study and whose family consent was given Exclusion Criteria: - Children with neurological signs that limit activities of daily living |
Country | Name | City | State |
---|---|---|---|
Turkey | Hasan Kalyoncu University | Gaziantep | Sahinbey |
Lead Sponsor | Collaborator |
---|---|
Hasan Kalyoncu University |
Turkey,
De la Corte-Rodriguez H, Rodriguez-Merchan EC. The role of physical medicine and rehabilitation in haemophiliac patients. Blood Coagul Fibrinolysis. 2013 Jan;24(1):1-9. doi: 10.1097/MBC.0b013e32835a72f3. — View Citation
Schafer GS, Valderramas S, Gomes AR, Budib MB, Wolff AL, Ramos AA. Physical exercise, pain and musculoskeletal function in patients with haemophilia: a systematic review. Haemophilia. 2016 May;22(3):e119-29. doi: 10.1111/hae.12909. Epub 2016 Apr 14. — View Citation
Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979 Mar;86(2):420-8. doi: 10.1037//0033-2909.86.2.420. — View Citation
Souza JC, Simoes HG, Campbell CS, Pontes FL, Boullosa DA, Prestes J. Haemophilia and exercise. Int J Sports Med. 2012 Feb;33(2):83-8. doi: 10.1055/s-0031-1286292. Epub 2011 Nov 17. — View Citation
Timmer MA, Gouw SC, Feldman BM, Zwagemaker A, de Kleijn P, Pisters MF, Schutgens REG, Blanchette V, Srivastava A, David JA, Fischer K, van der Net J. Measuring activities and participation in persons with haemophilia: A systematic review of commonly used instruments. Haemophilia. 2018 Mar;24(2):e33-e49. doi: 10.1111/hae.13367. Epub 2017 Nov 27. — View Citation
Wagner B, Kruger S, Hilberg T, Ay C, Hasenoehrl T, Huber DF, Crevenna R. The effect of resistance exercise on strength and safety outcome for people with haemophilia: A systematic review. Haemophilia. 2020 Mar;26(2):200-215. doi: 10.1111/hae.13938. Epub 2020 Feb 24. — View Citation
Young NL, Bradley CS, Blanchette V, Wakefield CD, Barnard D, Wu JK, McCusker PJ. Development of a health-related quality of life measure for boys with haemophilia: the Canadian Haemophilia Outcomes--Kids Life Assessment Tool (CHO-KLAT). Haemophilia. 2004 Mar;10 Suppl 1:34-43. doi: 10.1111/j.1355-0691.2004.00877.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Paediatric Haemophilia Activities List | PedHAL contains 22 items in 7 areas: sitting/kneeling/standing, functions of legs, functions of arms, use of transportation, personal care, housework and leisure activities, and sports. It consists of a child version (8-17 years old) and a parent version (4-17 years old). Items are scored for each item on a 6-point Likert scale ("impossible", "always", "usually", "sometimes", "almost never", "never"), "not applicable (N/A)". . The score is converted to a normalized score from 0 to 100, the higher score representing better functional status. If more than half of the items are missing or scored as "not applicable" (N/A), a valid total score will not be calculated. | through of the study, average 6 months | |
Primary | FISH | The scoring system, which is categorized according to the international classification of functionality, disability and health (ICF), has been prepared by considering the activities that hemophilia patients may be affected by in their daily lives. Being a performance-based scale allows it to be used in different languages. The scale consists of 8 questions in total, including the sub-parameters of self-care, transfer and locomotion. Self care subparameter; eating-hygiene, bathing and dressing, transfer sub-parameter; chair and squat, locomotion subparameter; It consists of walking, stair climbing (12-14 steps) and running activities.
Scoring of the activities is between 1 and 4 according to the degree of independence. The minimum score that can be obtained from the scale is 8, and the maximum score is 32. A high score indicates the functional independence of the individual. |
through of the study, average 6 months |
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