- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05879549
Comparison of Efficiency of Closed Kinetic Chain Exercises Versus Proprioceptive Exercises Patient With Hemophilia
Comparison of Efficiency of Closed Kinetic Chain Exercises Versus Proprioceptive Exercises in Improving Balance and Gait in Patient With Hemophilia
Hemophilia is a bleeding disorder caused by a deficiency of clotting factors in the blood. Muscle and joint bleeding are frequently observed in patients with hemophilia. Lower extremity bleeding can adversely affect balance, gait, and proprioception. The goal of this study; To compare the effectiveness of closed kinetic chain exercises and proprioceptive exercises on balance, proprioception and gait parameters in adolescent and young hemophilic individuals with lower extremity joint involvement.
The main question it aims to answer is:
Are the effects of closed kinetic chain exercises and proprioceptive exercises different on balance and walking in hemophilic individuals?
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Istanbul University-Cerrahpasa
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having been diagnosed with Hemophilia A and Hemophilia B
- Having a blood factor level below 5%,
- Between 13-25 years old
- History of bleeding to the lower extremity and target joint
- Total lower extremity Hemophilia joint health score ≥3
- Using prophylaxis
Exclusion Criteria:
- Having undergone lower extremity surgery in the last 6 months
- Having a Body Mass Index over 30 kg/m2
- Have an inhibitor
- Using a walking aid
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Closed Chain Exercise Group
Closed kinetic chain exercises will be given under the supervision of a physiotherapist, 2 sessions a week for 12 weeks.
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Closed Chain Exercise Group
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Experimental: Proprioceptive Exercise Group
Proprioceptive exercises will be given under the supervision of a physiotherapist, 2 sessions a week for 12 weeks.
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Proprioceptive Exercise Group
|
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No Intervention: Control Group
No intervention will be applied.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medio-lateral and Anterior-posterior stability index
Time Frame: 12 weeks
|
Represents fluctuations from the horizontal around the mediolateral axis.
Mediolateral sway and anterior-posterior stability will record in the double-leg stance for 20 seconds with Biodex Balance System.
The feet are placed in a comfortable position for patients, and the center of gravity was recorded in the system to begin the test.
Each test will repeat 3 times.
A higher sway index indicates a decrease in postural stability.
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12 weeks
|
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walking speed
Time Frame: 12 weeks
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A 10-meter walking test will be used to evaluate walking.
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12 weeks
|
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Hemophilia joint health score
Time Frame: 12 weeks
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The HJHS is derived from a physical examination of the index joints by a health care professional who should have training and expertise in the conduct of a detailed musculoskeletal (MSK) examination.
It is a measure of joint health and sits within the World .
The current HJHS version 2.1 comprises an assessment of specific features, or items, of the six index joints and an assessment of global gait.
For each of the six joints, the following items are scored: swelling (scored 0-3), duration of swelling (0-1), muscle atrophy (0-2), crepitus on motion (0-2), flexion loss (0-3), extension loss (0-3), joint pain (0-2), and strength (0-4).
The maximum score for an individual index joint is 20.
Gait is scored 0 to 4. The maximum HJHS total score is 124, with a higher score indicating worse joint health.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Single leg stance test
Time Frame: 12 weeks
|
The Single leg stance test (SLTS) measures static balance by challenging participants to stand unassisted on 1 leg. İndividuals stand for 30 or 45 seconds with their arms crossed across their chest or with their hands touching their hips. The SLST will completed with or without shoes and using the dominant or nondominant leg. The SLST will completed first with eyes open and then with eyes closed. Participants are timed as soon as their foot leaves the floor and stops once the foot touches the ground, the supporting foot shifts, their suspended foot touches the supporting leg, their eyes open in the eyes-closed trials, an arm is uncrossed or stops touching their hip, or if the maximum allotted time is reached. Three trials per condition are recorded, and either an average is calculated or the longest time is used. The SLST performance is reported in seconds (continuous) and requires a stopwatch. |
12 weeks
|
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Proprioception
Time Frame: 12 weeks
|
A digital goniometer will be used to evaluate proprioception.
The patient will be evaluated in a sitting position with eyes closed and open.
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12 weeks
|
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2-dimensional video-based gait kinematic analysis
Time Frame: 12 weeks
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2-dimensional video-based gait kinematic analysis is a simple, practical and inexpensive method in which a colour camera and passive markers are used.
Firstly, the fifth metatarsophalangeal joint, the lateral malleolus, the lateral femoral condyle, and the trochanter major will marked as anatomical landmarks.
Thereafter, passive markers will attached with double-sided adhesive tapes on the skin.
Video recordswere then obtained with a high-speed 2D video camera.
The camera will located on the tripod at a distance of 1.5 m from the patient, 0.86 m above the ground and with its optical axis perpendicular to the patients' sagittal axis.
The patient will be asked to walk at a normal pace in front of the camera.
The 2D records will processed using the Kinovea (version .8.15, Kinovea Open Source Project), which is a free 2D motion analysis will evaluate GKP.
During the phases (midstance, preswing, midswing, and late swing phases) requiring a maximal ROMin the knee and ankle joints, kinematic
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12 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-74555795-050.01.04-689576
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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