Virtual Evaluations of Joint Health Using Wearable Sensors in Persons With Haemophilia (VESPA)

NCT06046235 | Not Yet Recruiting

• 1 other identifier: 2021/HAEMO/01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Recent technological innovations have enabled the creation of portable and easy-to-wear sensors with incredible potential to alter the clinical practice of rehabilitation. Using wearable sensors we have gathered preliminary data in the clinical setting measuring walking ability and function. Preliminary data shows that these wearable sensors can detect improvements in walking ability and function after a 12-week physiotherapy exercise programme in boys with haemophilia. In this proposal, we want to test the use of these wearable sensors in the patient's home to remotely monitor joint health and the effects of rehabilitation for people with haemophilia. We expect that wearable sensor technology is an efficient and promising tool to evaluate and monitor joint health and pain in persons with haemophilia. If usable in the home setting, the wearable sensors have the potential to provide immediate real-time feedback on joint health and rehabilitation goals to the patient and their haemophilia care team without the patient having to leave their home. The project will also support educational activities with researchers and patients to ensure that the use of this new type of rehabilitation will be fully integrated with their future treatment and management.

Conditions

Haemophilia

Outcome Measures

Primary Outcomes (1)

• Knee and ankle joint range of motion using wearable Inertial Measurement Units (IMU) devices

  8 weeks

Eligibility Criteria

• Age: 13 Years+
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adolescents (13-17 years of age) and adults with Diagnosis of severe or moderate haemophilia (FVIII or FIX ≤ 5%)

You may qualify if:

• Diagnosis of severe or moderate haemophilia (FVIII or FIX ≤ 5%)
• Aged \> 12 years of age
• Inhibitor or non-inhibitor, previous or current

You may not qualify if:

• Diagnosis of mild haemophilia (FVIII or FIX \> 5%)
• Diagnosis of von Willebrand Disease or other bleeding disorder
• Aged ≤ 12 years of age
• Participants requiring a sterile environment
• The use of an oxygen-rich environment at a participant's home
• Participants or another person at the participant's home, with sensitive medical equipment whose functions may be compromised by the introduction of the IMU units, such as a pacemaker or implantable defibrillator
• Bedridden patients
• Patients with severe cognitive or psychiatric disorders as confirmed by a medical diagnosis

Sponsors & Collaborators

• East Kent Hospitals University NHS Foundation Trust: lead

Study Sites (1)

EKHUFT

Canterbury, Kent, CT1 3NG, United Kingdom

Location

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

CTU

CONTACT

+441227783169; ekhuft.clinicaltrialsunit@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: December 1, 2024
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-02

Locations

GB (1)