Postural Assessment, Therapeutic Exercise and Orthotic Devices in the Prevention of Haemophilic Arthropathy
NCT ID: NCT06438406
Last Updated: 2024-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2023-04-01
2024-05-27
Brief Summary
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The aim of this study is to verify the use of lower limb orthoses in combination with postural rehabilitation, assessing the incidence of spontaneous haemarthroses and haematomas as the primary endpoint and pain and QoL as secondary endpoints.
We conducted a prospective observational, randomised and controlled study on outpatients attending the UOC of Recovery and Functional Rehabilitation of the AOUP Paolo Giaccone of Palermo for haemophilic arthropathy sent by the UO of Haematology of the same hospital. The study period was between January 2017 and March 2023.
The patients recruited were randomly divided into two groups by means of a computer-generated random number system: group A, consisting of patients who were prescribed orthoses and a 20-session rehabilitation programme; group B, consisting of patients who were only prescribed orthoses for the lower limbs. The rehabilitation programme was based on the Back School method.
All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2).
Two arthropathic-specific scales were used to assess outcomes, namely the Hemophilia Joint Health Score (HJHS), which reflects joint function and status, and the Functional Independence Score in Hemophilia (FISH), which relates to the patient\'s quality of life. We also used the Numerical Rating Scale (NRS) for joint pain. Finally, postural assessment was performed in static posture, observing the patient\'s alignment in different planes and using the APECS (AI Posture Evaluation and Correction System ®) mobile app. During the re-evaluations, any new haemarthroses and haematomas were also assessed.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Orthotic devices and therapeutic exercise (Group A)
Group A consisting of patients who were prescribed orthoses, to use gradually, and a 20-session rehabilitation programme, based on the Back School method
Orthotic devices and therapeutic exercise (Group A)
Group A consisting of patients who were prescribed orthoses, to use gradually, and a 20-session rehabilitation programme, based on the Back School method
Orthotic devices (Group B)
Group B consisting of patients who were only prescribed orthoses for the lower limbs
Orthotic devices (Group B)
Group B consisting of patients who were only prescribed orthoses for the lower limbs
Orthotic devices and therapeutic exercise (Group A)
Group A consisting of patients who were prescribed orthoses, to use gradually, and a 20-session rehabilitation programme, based on the Back School method
Orthotic devices (Group B)
Group B consisting of patients who were only prescribed orthoses for the lower limbs
Interventions
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Orthotic devices and therapeutic exercise (Group A)
Group A consisting of patients who were prescribed orthoses, to use gradually, and a 20-session rehabilitation programme, based on the Back School method
Orthotic devices (Group B)
Group B consisting of patients who were only prescribed orthoses for the lower limbs
Eligibility Criteria
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Inclusion Criteria
* age ≥ 6 years and ≤ 50 years;
* presence of hindfoot and/or arch misalignment;
* prophylaxis with factor deficient (VIII or IX).
Exclusion Criteria
* uncooperative patients
6 Years
50 Years
MALE
No
Sponsors
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University of Palermo
OTHER
Responsible Party
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Prof.ssa Giulia Letizia Mauro
Professor
Locations
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A.O.U.P. Paolo Giaccone
Palermo, , Italy
Countries
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Other Identifiers
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MFR052024
Identifier Type: -
Identifier Source: org_study_id