Postural Assessment, Therapeutic Exercise and Orthotic Devices in the Prevention of Haemophilic Arthropathy

Not Applicable

Completed

• Conditions: Haemophilic Arthropathy; Orthosis; Foot Malalignment
• Interventions: Device: Orthotic devices and therapeutic exercise (Group A); Device: Orthotic devices (Group B)

• Registration Number: NCT06438406
• Lead Sponsor: University of Palermo

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 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

Not available

Study Timeline

• Study Start: 2023-04-01
• Primary Completion: 2023-10-30
• Status Verified: 2024-05
• Study Completion: 2024-05-27
• Study First Submitted: 2024-05-27
• Study First Submitted QC: 2024-05-27
• Last Update Submitted: 2024-05-27
• Study First Posted: 2024-05-31
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

• diagnosis of severe haemophilia A or B;
• age ≥ 6 years and ≤ 50 years;
• presence of hindfoot and/or arch misalignment;
• prophylaxis with factor deficient (VIII or IX).

Exclusion Criteria

• patients with prosthetic implants/synthetic means
• uncooperative patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orthotic devices (Group B)	Orthotic devices and therapeutic exercise (Group A)	Group B consisting of patients who were only prescribed orthoses for the lower limbs
Orthotic devices and therapeutic exercise (Group A)	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)	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)	Orthotic devices (Group B)	Group A consisting of patients who were prescribed orthoses, to use gradually, and a 20-session rehabilitation programme, based on the Back School method

Primary Outcome Measures

Name	Time	Method
prevention of haemophilic arthropathy	All patients were assessed at 3 months (T1) and after 6 months (T2).	During re-evaluations, the possible appearance of new haemarthroses and haematomas was assessed ,which were absent at the baseline examination

Secondary Outcome Measures

Name	Time	Method
Numerical Rating Scale (NRS)	All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2)	The NRS scale is a one-dimensional 11-point scale that assesses pain intensity in adults, with a range from 0 to 10, corresponding to 'no pain' and 'worst pain imaginable'
Functional Independence Score in Hemophilia (FISH)	All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2)	This score is a performance-based assessment tool used to measure the functional ability of patients. The maximum score is 32 (the greatest autonomy).
Hemophilia Joint Health Score (HJHS)	All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2)	The Hemophilia Joint Health Score is a rating scale that measures joint health in the domains of anatomical structure and function (biomechanics) of the joints most frequently affected by haemorrhage in haemophilia: knees, ankles, elbows.

Trial Locations

Locations (1)

A.O.U.P. Paolo Giaccone; 🇮🇹 Palermo, Italy