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

NCT06438406 | Completed DMC

• 1 other identifier: MFR052024
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Haemophilic Arthropathy; Orthosis; Foot Malalignment

Keywords

haemophilic arthropathy; orthosis; postural assestment; foot malalignment; therapeutic exercise; haemarthroses; haematomas; HJHS; FISH

Outcome Measures

Primary Outcomes (1)

• prevention of haemophilic arthropathy

  During re-evaluations, the possible appearance of new haemarthroses and haematomas was assessed ,which were absent at the baseline examination

  All patients were assessed at 3 months (T1) and after 6 months (T2).

Secondary Outcomes (3)

• Functional Independence Score in Hemophilia (FISH)

  All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2)

• Hemophilia Joint Health Score (HJHS)

  All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2)

• Numerical Rating Scale (NRS)

  All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2)

Study Arms (2)

Orthotic devices and therapeutic exercise (Group A)

ACTIVE COMPARATOR

Group A consisting of patients who were prescribed orthoses, to use gradually, and a 20-session rehabilitation programme, based on the Back School method

Device: Orthotic devices and therapeutic exercise (Group A); Device: Orthotic devices (Group B)

Orthotic devices (Group B)

ACTIVE COMPARATOR

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

Device: Orthotic devices and therapeutic exercise (Group A); Device: Orthotic devices (Group B)

Interventions

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); Orthotic devices and therapeutic exercise (Group A)

Orthotic devices (Group B) DEVICE

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

Orthotic devices (Group B); Orthotic devices and therapeutic exercise (Group A)

Eligibility Criteria

• Age: 6 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• patients with prosthetic implants/synthetic means
• uncooperative patients

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

A.O.U.P. Paolo Giaccone

Palermo, 90127, Italy

Location

MeSH Terms

Conditions

Hematoma

Interventions

Orthotic Devices; Exercise Therapy

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: May 31, 2024
• Study Start: April 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: May 27, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

IT (1)