Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438406
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2024-05-27
Brief Title:
Postural Assessment Therapeutic Exercise and Orthotic Devices in the Prevention of Haemophilic Arthropathy
Sponsor:
University of Palermo
Organization:
University of Palermo
Study Overview
Official Title:
Postural Assessment Therapeutic Exercise and Orthotic Devices in the Prevention of Haemophilic Arthropathy
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Haemophilic arthropathy HA is the most frequent complication of haemophilia and is often associated with a severe deterioration in quality of life It is caused by repeated joint bleeding resulting in chronic proliferative synovitis and progressive destruction of articular cartilage The most frequently affected joints are the knees ankles and elbows
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 patient39s quality of life We also used the Numerical Rating Scale NRS for joint pain Finally postural assessment was performed in static posture observing the patient39s 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
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 patient39s quality of life We also used the Numerical Rating Scale NRS for joint pain Finally postural assessment was performed in static posture observing the patient39s 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None