## Protocol Section
### Identification Module
**NCT ID:** NCT06438406

**Brief Title:** 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

#### Organization Study ID Info
**ID:** MFR052024
#### Organization
**Class:** OTHER
**Full Name:** University of Palermo
### Status Module
#### Completion Date
**Date:** 2024-05-27

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-10-30

**Type:** ACTUAL

#### Start Date
**Date:** 2023-04-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Palermo

#### Responsible Party

**Investigator Affiliation:** University of Palermo

**Investigator Full Name:** Prof.ssa Giulia Letizia Mauro

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Haemophilic Arthropathy

- Orthosis

- Foot Malalignment

**Keywords:**

- haemophilic arthropathy

- orthosis

- postural assestment

- foot malalignment

- therapeutic exercise

- haemarthroses

- haematomas

- HJHS

- FISH

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 15

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: Orthotic devices and therapeutic exercise (Group A)

- Device: Orthotic devices (Group B)

**Label:** Orthotic devices and therapeutic exercise (Group A)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Device: Orthotic devices and therapeutic exercise (Group A)

- Device: Orthotic devices (Group B)

**Label:** Orthotic devices (Group B)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Orthotic devices (Group B)

- Orthotic devices and therapeutic exercise (Group A)

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

**Name:** Orthotic devices and therapeutic exercise (Group A)

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Orthotic devices (Group B)

- Orthotic devices and therapeutic exercise (Group A)

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

**Name:** Orthotic devices (Group B)

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** prevention of haemophilic arthropathy

**Time Frame:** All patients were assessed at 3 months (T1) and after 6 months (T2).

#### Secondary Outcomes

**Description:** This score is a performance-based assessment tool used to measure the functional ability of patients. The maximum score is 32 (the greatest autonomy).

**Measure:** Functional Independence Score in Hemophilia (FISH)

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

**Description:** 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.

**Measure:** Hemophilia Joint Health Score (HJHS)

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

**Description:** 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'

**Measure:** Numerical Rating Scale (NRS)

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

### Eligibility Module

**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

**Gender Based:** True

**Maximum Age:** 50 Years

**Minimum Age:** 6 Years

**Sex:** MALE

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Palermo

**Country:** Italy

**Facility:** A.O.U.P. Paolo Giaccone

**Zip:** 90127

### IPD Sharing Statement Module

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

- ANALYTIC_CODE

**IPD Sharing:** YES

**URL:** https://www.unipa.it/persone/docenti/l/giulia.letiziamauro/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10621

- Name: Joint Diseases

- Relevance: HIGH

- As Found: Arthropathy

- ID: M9493

- Name: Hematoma

- Relevance: LOW

- As Found: Unknown

- ID: M9483

- Name: Hemarthrosis

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T2713

- Name: Hemophilic Arthropathy

- Relevance: HIGH

- As Found: Hemophilic Arthropathy

### Condition Browse Module - Meshes

- ID: D000007592

- Term: Joint Diseases

### Misc Info Module

- Version Holder: 2024-05-31
