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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04308876
Other study ID # Necmettin Erb. Physiotherapy-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 9, 2018
Est. completion date February 6, 2020

Study information

Verified date March 2020
Source Necmettin Erbakan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date February 6, 2020
Est. primary completion date March 10, 2019
Accepts healthy volunteers No
Gender Male
Age group 12 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Manual therapy
Manual therapy includes techniques applied to elbow joints and surrounding tissues
Strengthening exercises
Strengthening exercises used in this study includes resistant exercises to increase muscle strength of upper extremity

Locations

Country Name City State
Turkey Cukurova University Adana Saricam

Sponsors (1)

Lead Sponsor Collaborator
Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 5 week
Primary Frequency of bleeding It was evaluated wit bleeding number in elbow joint over last 5 week 5 week
Primary Numerical Pain Scale It was used for evaluation of activity and resting pain. 5 week
Secondary Range of motion It was measured with universal goniometer. 5 week
Secondary Muscle strength It was measured with digital dynamometer (Lafayette hand-held dynamometer) 5 week
Secondary Functionality of the upper extremity Quick-Disability of Arm, Shoulder and Hand questionnaire was used. 5 week
Secondary Oxford Elbow Score It was used for evaluation of Quality of life. 5 week
Secondary Physical status of the elbow Hospital for Special Surgery-Elbow Scoring System was used. 5 week
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