Clinical trial NCT06438406: Postural Assessment, Therapeutic Exercise and Orthotic Devices in the Prevention of Haemophilic Arthropathy
Official title: Postural Assessment, Therapeutic Exercise and Orthotic Devices in the Prevention of Haemophilic Arthropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Haemophilic Arthropathy
Orthosis
Foot Malalignment
Keywords: haemophilic arthropathy
orthosis
postural assestment
foot malalignment
therapeutic exercise
haemarthroses
haematomas
HJHS
FISH
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 15
Sex: MALE
Minimum age (years): 6
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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\&#39;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\&#39;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.


Eligibility criteria: 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

Primary outcomes:
measure: prevention of haemophilic arthropathy
timeFrame: All patients were assessed at 3 months (T1) and after 6 months (T2).
Secondary outcomes:
measure: Functional Independence Score in Hemophilia (FISH)
timeFrame: All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2)
measure: Hemophilia Joint Health Score (HJHS)
timeFrame: All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2)
measure: Numerical Rating Scale (NRS)
timeFrame: All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2)
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: A.O.U.P. Paolo Giaccone
Study officials:
References: