Clinical, Functional and Musculoskeletal Differences Between Adult Patients With Hemophilia and Their Healthy Peers

NCT05589662 | Unknown

• 1 other identifier: He-BloodCC
• Study Type: observational
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background. Hemophilia is characterized by the development of a progressive, degenerative, intra-articular lesion (hemophilic arthropathy). This arthropathy presents with chronic pain, limited range of motion, axial changes, and periarticular muscle atrophy. Goal. To analyze the clonic, functional and musculoskeletal differences between adult patients with hemophilic arthropathy of the knee and ankle and their healthy peers. Study design. Cases and controls study patients. 21 patients with hemophilia A and B and 21 subjects without joint damage. Variables and measuring instruments: pressure pain threshold (pressure algometer); joint status (Hemophilia Joint Health Score scale); and strength (dynamometry) and muscle activation (surface electromyography). Expected results. Observe the differences between patients with knee and ankle arthropathy and their healthy peers in muscle strength and activation.

Conditions

Hemophilia Arthropathy

Keywords

Hemophilic arthropathy; Ankle; Knee; Strength; Muscle activation; Pressure pain threshold

Outcome Measures

Primary Outcomes (1)

• Assess the muscle strength

  The force will be measured with a pressure dynamometer (Lafayette Manual muscle Tester model 01165). This device measures in Newton the force exerted by the patient in the requested muscular action. The higher the value, the greater muscle strength. We will perform the measurements bilaterally. Strength in the quadriceps and triceps surae muscles will be measured. The patient will be asked for 2 maximum isometric contractions of 5 seconds, with a rest of 30 seconds between them. In all the measurements, the evaluator will encourage the patient in a standardized way to carry out the contractions. In the measurement of the strength of all the muscles evaluated, the mean value of the measurements obtained will be used as a measure.

  Screening visit

Secondary Outcomes (3)

• Assess the muscle activation

  Screening visit

• Assess the pressure pain threshold

  Screening visit

• Assess the joint status

  Screening visit

Study Arms (2)

Hemophilia group

Patients with hemophilia, older than 18 years, with a diagnosis of hemophilic arthropathy of the knee and ankle. The different study variables will be evaluated following the indicated protocol.

Other: Clinical and functional assessment

Healthy peers.group

Healthy subjects, older than 18 years, without joint damage at the time of the study, and physically active. The different study variables will be evaluated following the indicated protocol.

Other: Clinical and functional assessment

Interventions

Clinical and functional assessment OTHER

The dependent variables (muscle strength, muscle activation, pressure pain threshold and joint status) and the outcome measures used to measure these variables will be: pressure dynamometer, surface electromyography, pressure algometer and Hemophilia Joint Health Score

Healthy peers.group; Hemophilia group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hemophilic arthropathy and their healthy pairs

You may qualify if:

• Patients diagnosed with hemophilia A and B.
• Over 18 years
• With medical diagnosis of knee arthropathy
• With clinical evaluation by Hemophilia Joint Health Score
• In prophylactic treatment or on demand with FVIII / FIX concentrates for coagulation.
• Healthy subjects must meet knee joint health criteria; over 18 years; and no previous knee or ankle injuries in the 6 months prior to evaluation.

You may not qualify if:

• Patients with neurological or cognitive disorders that prevent the understanding of physical tests
• Not having signed the informed consent document

Sponsors & Collaborators

• Investigación en Hemofilia y Fisioterapia: lead

Study Officials

• Rubén Cuesta-Barriuso, PhD

  University of Oviedo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rubén Cuesta-Barriuso, PhD

CONTACT

0034985103386; cuestaruben@uniovi.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: November 21, 2022
• Primary Completion: November 28, 2022
• Study Completion: December 23, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share