Poyraz Isleyen Tugce, Tarakci Ela, Leblebici Gokce, Yeldan Ipek, Zulfikar Bulent
Department of Physiotherapy and Rehabilitation, Institute of Graduate Studies, Istanbul University-Cerrahpaşa, Istanbul, Turkey.
Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Bahçeşehir University, Istanbul, Turkey.
JMIR Res Protoc. 2025 Apr 24;14:e66770. doi: 10.2196/66770.
Inherited bleeding disorders involve prolonged bleeding due to clotting protein deficiencies, with hemophilia A and B being the most common types. The severity of bleeding in people with hemophilia depends on the deficient factor level. Treatment includes coagulation factor concentrates, nonreplacement preparations, gene therapies, and physiotherapy, whereby bleeding is prevented, symptoms are reduced, and the quality of life is improved. Closed kinetic chain exercises improve joint stability and neuromuscular control by stabilizing the proximal base, making them favored in musculoskeletal rehabilitation. Proprioceptive exercise training improves the sensorimotor system's adaptability and injury prevention through tailored programs involving progressively complex movements and surfaces.
The aim of this study is to investigate the effects of closed kinetic chain exercises and proprioceptive exercise training on improving balance and walking in people with hemophilia.
This study is a 3-arm, parallel-group randomized controlled trial with 63 people with hemophilia aged 13-25 years who meet the inclusion criteria. The primary outcome measures are medio-lateral swing, anterior-posterior swing, walking speed, and Hemophilia Joint Health Score. Secondary outcome measures are kinematic assessment of gait, one-leg stand test, 6-minute walk distance (6MWD) test, proprioception assessment, and the Functional Independence Score in Hemophilia. Participants will be evaluated with the Biodex balance system for postural sway, 10-meters walking test for gait speed, Hemophilia Joint Health Score for joint health, Kinovea 2D motion analysis for kinematic evaluation of gait, one-leg stand test for balance measurement, 6MWD for functional capacity, digital goniometer for proprioception, and Functional Independence Score in Hemophilia for functional independence. Participants will be randomly assigned to a closed kinetic chain exercise group, a proprioceptive exercise group, or a control group. All participants in exercise training groups will receive a 30-minute education session on joint protection techniques and energy conservation prior to the first exercise session. Closed kinetic chain exercises will include progressive lower limb exercises of approximately 45 minutes each session. Proprioceptive exercise training will focus on vibration training; reposition exercises and proprioception exercises will be administered to increase proprioceptive input for the same duration as the other group. The control group will receive no intervention. All participants will undergo 24 exercise sessions (2 days a week for 12 weeks). After the treatment, the initial measurements will be repeated.
This study began in September 2023 and is scheduled to be completed in May 2025. A total of 34 participants have completed the study to date.
This study will investigate the effects of 2 different exercises on functional parameters in people with hemophilia. The effects of different exercise protocols on parameters such as postural sway, walking speed, and joint health will be evaluated. It is predicted that both exercise methods may have positive effects on balance and gait.
Clinical Trials.gov NCT05879549; https://clinicaltrials.gov/study/NCT05879549.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/66770.
遗传性出血性疾病因凝血蛋白缺乏导致出血时间延长，其中甲型和乙型血友病最为常见。血友病患者的出血严重程度取决于缺乏的凝血因子水平。治疗方法包括凝血因子浓缩物、非替代制剂、基因疗法和物理治疗，通过这些方法可预防出血、减轻症状并提高生活质量。闭链运动通过稳定近端基础来改善关节稳定性和神经肌肉控制，因此在肌肉骨骼康复中备受青睐。本体感觉运动训练通过涉及逐渐复杂的动作和表面的定制方案，提高感觉运动系统的适应性并预防损伤。
本研究旨在调查闭链运动和本体感觉运动训练对改善血友病患者平衡能力和步行能力的影响。
本研究为三臂平行组随机对照试验，纳入63名年龄在13至25岁之间符合纳入标准的血友病患者。主要结局指标为左右摆动、前后摆动、步行速度和血友病关节健康评分。次要结局指标包括步态的运动学评估、单腿站立试验、6分钟步行距离（6MWD）试验、本体感觉评估以及血友病功能独立评分。将使用Biodex平衡系统评估参与者的姿势摆动，使用10米步行试验评估步态速度，使用血友病关节健康评分评估关节健康状况，使用Kinovea二维运动分析评估步态的运动学，使用单腿站立试验测量平衡能力，使用6MWD评估功能能力，使用数字角度计评估本体感觉，使用血友病功能独立评分评估功能独立性。参与者将被随机分配到闭链运动组、本体感觉运动组或对照组。运动训练组的所有参与者在第一次运动前将接受30分钟的关节保护技术和节能教育课程。闭链运动每次约45分钟，包括下肢渐进性运动。本体感觉运动训练将侧重于振动训练；将进行重新定位练习和本体感觉练习，以增加本体感觉输入，持续时间与另一组相同。对照组不接受干预。所有参与者将进行24次运动（每周2天，共12周）。治疗后，将重复初始测量。
本研究于2023年9月开始，计划于2025年5月完成。截至目前，共有34名参与者完成了研究。
本研究将调查两种不同运动对血友病患者功能参数的影响。将评估不同运动方案对姿势摆动、步行速度和关节健康等参数的影响。预计两种运动方法都可能对平衡和步态产生积极影响。
ClinicalTrials.gov NCT05879549；https://clinicaltrials.gov/study/NCT05879549。
国际注册报告识别码（IRRID）：DERR1-10.2196/66770。
