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

Primary Purpose

Hemophilia, Arthritis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manual therapy
Strengthening exercises
Sponsored by
Necmettin Erbakan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia focused on measuring Hemophilia, Arthropathy, Elbow joint, Manual therapy, Exercise

Eligibility Criteria

12 Years - 35 Years (Child, Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cukurova University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manual therapy and strengthening exercises

Strengthening exercises

Arm Description

Manual therapy and strengthening exercises were applied totally 15 sessions for 5 weeks 3 times a week in hospital by physiotherapist.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 12, 2020
Last Updated
March 12, 2020
Sponsor
Necmettin Erbakan University
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1. Study Identification

Unique Protocol Identification Number
NCT04308876
Brief Title
Effectiveness of Manual Therapy and Strengthening Exercises in Hemophilic Arthropathy of the Elbow Joint
Official Title
Investigation of Effectiveness of Manual Therapy and Strengthening Exercises in Physiotherapy and Rehabilitation of Hemophilic Arthropathy of the Elbow
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
March 10, 2019 (Actual)
Study Completion Date
February 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Necmettin Erbakan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia, Arthritis
Keywords
Hemophilia, Arthropathy, Elbow joint, Manual therapy, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual therapy and strengthening exercises
Arm Type
Experimental
Arm Description
Manual therapy and strengthening exercises were applied totally 15 sessions for 5 weeks 3 times a week in hospital by physiotherapist.
Arm Title
Strengthening exercises
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Manual therapy
Intervention Description
Manual therapy includes techniques applied to elbow joints and surrounding tissues
Intervention Type
Other
Intervention Name(s)
Strengthening exercises
Intervention Description
Strengthening exercises used in this study includes resistant exercises to increase muscle strength of upper extremity
Primary Outcome Measure Information:
Title
Hemophilia Joint Health Score
Description
We used the elbow point of Joint Health Status. Elbow Point is scored 0-20. A high score indicates that arthropathy findings worsen
Time Frame
5 week
Title
Frequency of bleeding
Description
It was evaluated wit bleeding number in elbow joint over last 5 week
Time Frame
5 week
Title
Numerical Pain Scale
Description
It was used for evaluation of activity and resting pain.
Time Frame
5 week
Secondary Outcome Measure Information:
Title
Range of motion
Description
It was measured with universal goniometer.
Time Frame
5 week
Title
Muscle strength
Description
It was measured with digital dynamometer (Lafayette hand-held dynamometer)
Time Frame
5 week
Title
Functionality of the upper extremity
Description
Quick-Disability of Arm, Shoulder and Hand questionnaire was used.
Time Frame
5 week
Title
Oxford Elbow Score
Description
It was used for evaluation of Quality of life.
Time Frame
5 week
Title
Physical status of the elbow
Description
Hospital for Special Surgery-Elbow Scoring System was used.
Time Frame
5 week

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filiz Can, Professor
Organizational Affiliation
Hacettepe University, Faculty of Physical Therapy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ilgen Sasmaz
Organizational Affiliation
Cukurova University, Faculty of Medicine, Department of Pediatric Hematology
Official's Role
Study Director
Facility Information:
Facility Name
Cukurova University
City
Adana
State/Province
Sarıcam
Country
Turkey

12. IPD Sharing Statement

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

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