Effectiveness of Manual Therapy and Strengthening Exercises in Hemophilic Arthropathy of the Elbow Joint

March 12, 2020 updated by: Ayse Merve Tat, Necmettin Erbakan University

Investigation of Effectiveness of Manual Therapy and Strengthening Exercises in Physiotherapy and Rehabilitation of Hemophilic Arthropathy of the Elbow

Manual treatment involves techniques based on the principles of moving the joint faces and separating the joint gap, and soft tissues mobilization techniques. The use of manual therapy in hemophilia is gradually increasing although it previously described as a contraindication. The utility and use of strengthening exercises in hemophilia has been going on for a long time. In this study, the effect of manual therapy and strengthening exercises joint was investigated in hemophilic arthropathy of the elbow.

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

The aim of this study was to investigate the effects of strengthening exercises and manual therapy on bleeding frequency, pain, range of motion, muscle strength, arm circumference, joint health, functionality and quality of life in the physiotherapy and rehabilitation of hemophilic arthropathy of the elbow. Seventeen adolescent and young adult hemophilic individuals aged 12-30 years with elbow arthropathy were included in the study. The individuals were divided into the two groups via simple randomisation as Manuel Therapy and Exercise Group (MTEG) and Home Exercise Group (HEG). The individuals in HEG were given strengthening exercises as a home program. Those in the MTEG were applied manual therapy by the physiotherapist and were given supervised strengthening exercises. All treatments were performed 3 times a week for 5 weeks totally 15 sessions. Frequency of bleeding was evaluated with number of bleeding in the last 5 weeks. Numerical Pain Scale was used for activity and resting pain. Range of motion and muscle strength were measured with universal goniometer and digital dynamometer, respectively. The Quick-DASH questionnaire and Oxford Elbow Score were used for the functionality of the upper extremity and quality of life, respectively. The joint health status was evaluated with Hemophilia Joint Health Score-Elbow Point and Hospital for Special Surgery-Elbow Scoring System. Evaluations were made by the same physiotherapist before and after treatment.

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.
17

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

  • Turkey
    • Sarıcam
      • Adana, Sarıcam, Turkey
        • Cukurova University

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

12 years to 35 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Having signs of hemophilic arthropathy in one or both elbow joints, Being between the ages of 12-30 (Adolescent and young adult), Receiving prophylactic factor replacement therapy.

Exclusion Criteria:

  • Having undergone any surgical procedure for elbow arthropathy, Having an orthopedic problem, such as a fracture, ligament or tendon injury, related to the upper limb in the past year, Receiving physiotherapy and rehabilitation for the elbow joint in the last 6 months

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
  • Masking: NONE

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 and strengthening exercises
Manual therapy and strengthening exercises were applied totally 15 sessions for 5 weeks 3 times a week in hospital by physiotherapist.
Other: Manual therapy
Manual therapy includes techniques applied to elbow joints and surrounding tissues
Other: Strengthening exercises
Strengthening exercises used in this study includes resistant exercises to increase muscle strength of upper extremity
ACTIVE_COMPARATOR: Strengthening exercises
Patients in this group performed the strengthening exercises given to the experimental group on their own at home with experimental group at the same time, frequency and dose.
Other: Strengthening exercises
Strengthening exercises used in this study includes resistant exercises to increase muscle strength of upper extremity

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
Hemophilia Joint Health Score
Time Frame: 5 week
We used the elbow point of Joint Health Status. Elbow Point is scored 0-20. A high score indicates that arthropathy findings worsen
5 week
Frequency of bleeding
Time Frame: 5 week
It was evaluated wit bleeding number in elbow joint over last 5 week
5 week
Numerical Pain Scale
Time Frame: 5 week
It was used for evaluation of activity and resting pain.
5 week

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
Range of motion
Time Frame: 5 week
It was measured with universal goniometer.
5 week
Muscle strength
Time Frame: 5 week
It was measured with digital dynamometer (Lafayette hand-held dynamometer)
5 week
Functionality of the upper extremity
Time Frame: 5 week
Quick-Disability of Arm, Shoulder and Hand questionnaire was used.
5 week
Oxford Elbow Score
Time Frame: 5 week
It was used for evaluation of Quality of life.
5 week
Physical status of the elbow
Time Frame: 5 week
Hospital for Special Surgery-Elbow Scoring System was used.
5 week

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.
Necmettin Erbakan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Filiz Can, Professor, Hacettepe University, Faculty of Physical Therapy
  • Study Director: Ilgen Sasmaz, Cukurova University, Faculty of Medicine, Department of Pediatric Hematology

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 (ACTUAL)

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.
April 9, 2018

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.
March 10, 2019

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.
February 6, 2020

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).
March 12, 2020

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.
March 12, 2020

First Posted (ACTUAL)

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.
March 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

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.
March 16, 2020

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.
March 12, 2020

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.
March 1, 2020

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.
  • Necmettin Erb. Physiotherapy-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings