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NCT Number: NCT06438406

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

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.

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Key information

Conditions

Haemophilic Arthropathy Foot Malalignment Hematoma Hemorrhage Orthosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

6 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

A.O.U.P. Paolo Giaccone

Palermo, 90127, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orthotic devices and therapeutic exercise (Group A)

Device

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)

Device

Group B consisting of patients who were only prescribed orthoses for the lower limbs

Primary outcomes

  1. prevention of haemophilic arthropathy

    Time frame: 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 outcomes

  1. Functional Independence Score in Hemophilia (FISH)

    Time frame: 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).

  2. Hemophilia Joint Health Score (HJHS)

    Time frame: 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.

  3. Numerical Rating Scale (NRS)

    Time frame: 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'

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 31, 2024
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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