Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
MALE
Healthy Volunteers
ID06816056

Safety and Efficacy of Manual Therapy in the Treatment of Haemophilic Arthropathy of the Ankle. A Randomised Multicentre Clinical Trial

Led by Investigación en Hemofilia y Fisioterapia · Updated on 2025-02-10

13

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a manual therapy protocol for patients with haemophilic ankle arthropathy, a condition causing muscle weakness, reduced mobility, joint degeneration, and chronic pain. This randomised crossover clinical trial involves 13 patients with haemophilia A or B and severe haemophilia phenotype, aiming to observe changes in pain, mobility, joint condition, balance, functionality, and fear of movement. Participants will be randomly assigned to either an experimental group receiving manual therapy or a control group receiving a placebo physiotherapy intervention. The experimental treatment includes 10 specific manual therapy techniques applied bilaterally during 50-minute sessions once a week for 3 weeks. The control group will receive the same number and duration of sessions but without the active mobilisation or manipulation techniques. Participants will be evaluated at the start of the study, after completing the 3-week intervention, and again after a 4-week follow-up period. Assessments include frequency of ankle haemarthrosis, range of motion, pain intensity and pressure pain threshold, joint status, gait and balance analysis, functional capacity, and kinesiophobia. Safety and changes in these outcomes will be monitored throughout the study.

CONDITIONS

Brief Title

Manual Therapy in Hemophilic Arthropathy of the Ankle

Who Can Participate

Age: 18Years - 65Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with haemophilia A and B
  • Severe haemophilia phenotype (less than 1% FVIII/FIX)
  • Aged 18 to 65 years
  • Medical diagnosis of ankle arthropathy with clinical assessment using the Hemophilia Joint Health Score
  • Receiving prophylactic or on-demand treatment with coagulation factor VIII/FIX concentrates
Not Eligible

You will not qualify if you...

  • Neurological or cognitive disorders that prevent understanding questionnaires and physical tests
  • Failure to sign the informed consent document

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 weeks

Participants receive manual therapy or placebo physiotherapy sessions targeting ankle arthropathy. The intervention includes weekly 50-minute sessions involving various mobilisation and manipulation techniques or similar placebo techniques without actual manipulation.

3 weekly sessions (in-person)

Follow-up

Duration - 4 weeks

Participants are monitored for changes in joint health, pain, functional capacity, and other outcomes after treatment.

2 visits (within 7 days after treatment and at 4 weeks post-treatment, in-person)

Trial Site Locations

Total: 1 location

1

Universidad Católica San Antonio

Murcia, Spain

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Research Team

R

Rubén Cuesta-Barriuso, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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