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

May 27, 2024 updated by: Prof.ssa Giulia Letizia Mauro, University of Palermo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Palermo, Italy, 90127
        • A.O.U.P. Paolo Giaccone

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Device: 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
Device: Orthotic devices (Group B)
Group B consisting of patients who were only prescribed orthoses for the lower limbs
Active Comparator: Orthotic devices (Group B)
Group B consisting of patients who were only prescribed orthoses for the lower limbs
Device: 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
Device: Orthotic devices (Group B)
Group B consisting of patients who were only prescribed orthoses for the lower limbs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
All patients were assessed at 3 months (T1) and after 6 months (T2).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2)
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.
All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2)
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'
All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Palermo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

October 30, 2023

Study Completion (Actual)

May 27, 2024

Study Registration Dates

First Submitted

May 27, 2024

First Submitted That Met QC Criteria

May 27, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 27, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFR052024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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