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Comparison of Efficiency of Closed Kinetic Chain Exercises Versus Proprioceptive Exercises Patient With Hemophilia

Primary Purpose

Hemophilia A, Hemophilia B

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Closed Chain Exercise Group
Proprioceptive Exercise Group
Sponsored by
Bahçeşehir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia A focused on measuring hemophilia, exercise, balance, proprioception

Eligibility Criteria

13 Years - 25 Years (Child, Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • İstanbul University-Cerrahpaşa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Closed Chain Exercise Group

Proprioceptive Exercise Group

Control Group

Arm Description

Closed kinetic chain exercises will be given under the supervision of a physiotherapist, 2 sessions a week for 12 weeks.

Proprioceptive exercises will be given under the supervision of a physiotherapist, 2 sessions a week for 12 weeks.

No intervention will be applied.

Outcomes

Primary Outcome Measures

Medio-lateral and Anterior-posterior stability index
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.
walking speed
A 10-meter walking test will be used to evaluate walking.
Hemophilia joint health score
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.

Secondary Outcome Measures

Single leg stance test
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.
Proprioception
A digital goniometer will be used to evaluate proprioception. The patient will be evaluated in a sitting position with eyes closed and open.
2-dimensional video-based gait kinematic analysis
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

Full Information

First Posted
May 5, 2023
Last Updated
September 8, 2023
Sponsor
Bahçeşehir University
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1. Study Identification

Unique Protocol Identification Number
NCT05879549
Brief Title
Comparison of Efficiency of Closed Kinetic Chain Exercises Versus Proprioceptive Exercises Patient With Hemophilia
Official Title
Comparison of Efficiency of Closed Kinetic Chain Exercises Versus Proprioceptive Exercises in Improving Balance and Gait in Patient With Hemophilia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia A, Hemophilia B
Keywords
hemophilia, exercise, balance, proprioception

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Closed Chain Exercise Group
Arm Type
Experimental
Arm Description
Closed kinetic chain exercises will be given under the supervision of a physiotherapist, 2 sessions a week for 12 weeks.
Arm Title
Proprioceptive Exercise Group
Arm Type
Experimental
Arm Description
Proprioceptive exercises will be given under the supervision of a physiotherapist, 2 sessions a week for 12 weeks.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention will be applied.
Intervention Type
Other
Intervention Name(s)
Closed Chain Exercise Group
Intervention Description
Closed Chain Exercise Group
Intervention Type
Other
Intervention Name(s)
Proprioceptive Exercise Group
Intervention Description
Proprioceptive Exercise Group
Primary Outcome Measure Information:
Title
Medio-lateral and Anterior-posterior stability index
Description
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.
Time Frame
12 weeks
Title
walking speed
Description
A 10-meter walking test will be used to evaluate walking.
Time Frame
12 weeks
Title
Hemophilia joint health score
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Single leg stance test
Description
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.
Time Frame
12 weeks
Title
Proprioception
Description
A digital goniometer will be used to evaluate proprioception. The patient will be evaluated in a sitting position with eyes closed and open.
Time Frame
12 weeks
Title
2-dimensional video-based gait kinematic analysis
Description
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
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tuğçe Poyraz İşleyen
Phone
+90 212 381 0000
Ext
9216
Email
fzt.tugcepoyraz@gmail.com
Facility Information:
Facility Name
İstanbul University-Cerrahpaşa
City
Istanbul
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
tuğçe poyraz
Email
fzt.tugcepoyraz@gmail.com
First Name & Middle Initial & Last Name & Degree
Ela TARAKCI, Prof.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33486846
Citation
Tat NM, Tat AM, Oner AF, Karaman K, Kaplan S, Can F. Static postural balance evaluation and an investigation of the relationship with joint health in children with severe haemophilia: a controlled cross-sectional study. Haemophilia. 2021 Mar;27(2):e245-e252. doi: 10.1111/hae.14240. Epub 2021 Jan 24.
Results Reference
background

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Comparison of Efficiency of Closed Kinetic Chain Exercises Versus Proprioceptive Exercises Patient With Hemophilia

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