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

Orthosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06438406
• Other study ID #: MFR052024
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: May 27, 2024

Study information

• Verified date: May 2024
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 27, 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Orthosis

Intervention

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
• Orthotic devices (Group B)
Group B consisting of patients who were only prescribed orthoses for the lower limbs

Locations

Country	Name	City	State
Italy	A.O.U.P. Paolo Giaccone	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Functional Independence Score in Hemophilia (FISH)	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)
Secondary	Hemophilia Joint Health Score (HJHS)	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)
Secondary	Numerical Rating Scale (NRS)	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)