Manual Therapy in Haemophilic Arthropathy of the Knee (ARTHROPA)

July 22, 2014 updated by: RUBÉN CUESTA-BARRIUSO, Universidad Católica San Antonio de Murcia

Effectiveness of Manual Therapy and Educational Physiotherapy in the Treatment of Hemophilic Arthropathy of the Knee. A Randomized Pilot Study

This study aims to assess the effectiveness of two Physiotherapy treatments: one with manual therapy using joint traction, passive muscle stretching, and isometric exercise, active resisted and proprioception exercises; and other treatment with educational sessions and home exercises to improve the ROM, muscle strength and proprioception in patients with haemophilia and arthropathy of the knee.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Randomized trial with two treatment groups: one using joint traction, passive muscle stretching and isometric exercises, active resisted and proprioception exercises (group MT); and another with educational sessions and home exercises (group E); and a control group (group C).

The intervention was carried out during twelve weeks, performing evaluation before and after treatment, and six months of finalizing this. The treatment in MT group consisted of two sessions per week for one hour each, and the treatment in group E consisted of a session of 90 minute every two weeks, with exercises daily home. The control group (group C) did not receive any treatment. After the allocation to the groups, the composition was follows: MT group = 7; E group = 7; and control group = 7.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30100
        • Universidad de Murcia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients must be over the age of 18 years
  • Diagnosis of haemophilia A or B
  • Patients with haemophilic arthropathy in one or both knees

Exclusion Criteria:

  • Patients who had a haemarthrosis of knee during intervention
  • Patients with different medical diagnosis (eg, Von Willebrand's disease)
  • Patients with antibodies to FVIII or FIX (inhibitors).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Manual Therapy group
We employed joint traction, passive muscle stretching and isometric exercises, active resisted and proprioception exercises. The treatment in this group consisted of two sessions per week for one hour each.
Other: Manual Therapy

5 minutes. Thermotherapy shallow to 50 cm away from the knee. 15 minutes. Joint traction, grade I-II. Fixation of distal femur with cinch and manual fixation of proximal tibia. Patient in prone position and the traction is carried out in the submaximal ranges of flexion and extension.

10 minutes. Passive muscle stretching of quadriceps (within the limits of mobility), through compression muscle, passive muscle stretching and relaxation of muscle.

10 minutes. Isometric and resisted exercises of quadriceps, in submaximal ranges, of flexion and extension.

10 minutes. Proprioception exercises with unipodal support, with and without visual support, and posterior destabilization.

10 minutes. Local cryotherapy with ice pack.
Experimental: Educational gruop

This group received educational sessions and home exercises. The exercises are aimed at improving quadriceps strength, flexibility, range of motion and knee proprioception.

Each educational session of 90 minute every two weeks, with exercises daily home
Other: Educational Physiotherapy
  • Theory. Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of knee; Anatomy of ankle musculature; Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.
  • Practice: exercises in favor of gravity; active exercises for mobility and pain management; knee proprioception exercises; isometric and isotonic exercises of quadriceps; swimming and cycling technique.
No Intervention: Control group
The control group (group C) did not receive any treatment. The patients of this group were assessed by the same reviewers and under the same conditions as the subjects of the two intervention groups.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in the range of movement (ROM)
Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Measurement of knee flexion and extension using a universal goniometer. Were taken as anatomical references, are indicated by Querol et al, using the reference method 0 to the mobile arm of the goniometer, as noted Norkin et al.
Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Changes in quadriceps muscle circumference
Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Measurement in the thigh, in two thirds of the flow distance between the anterior superior iliac spine and the joint line of the knee, using a tape measure
Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Changes in muscle strength of quadriceps
Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Measured by the rupture test for hemophilia patients (with a gradation of 0 to 5 points, with 0 indicating normal strength and 5 is the absence of muscle contraction).
Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Changes in the perception of pain
Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Using the visual analog scale, VAS, consisting of a gradation of 0 to 10 points (from no pain to worst pain imaginable).
Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Changes in the assessment of radiological joint deterioration
Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
We use the Petterson scale which consists of 13 items (0 indicates a normal joint and joint deterioration 13 maximum).
Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subjects' physical characteristics
Time Frame: Screening visit (pretreatment assessment)
Age of patient (years), Weight of patient (kg), Number of ankle haemarthrosis in previous year, Type of haemophilia (A or B), Severity of haemophilia (severe or moderate), Treatment (prophylaxis or on demand).
Screening visit (pretreatment assessment)
Changes in the frequency of knee hemarthrosis
Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Evaluation of knee bleeding before, during and after physiotherapy treatment. Hemarthrosis must be diagnosed clinically.
Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Católica San Antonio de Murcia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ARTHROPATHY
  • ARTHROPAT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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