The Effect of Dynamic Balance Exercises Added to Current Medical Treatment on Balance in Patients With Ankylosing Spondylitis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Hakan Alkan
- 入组人数
- 40
- 主要终点
- Dynamic balance measurements
研究概览
简要总结
The aim of the study is to investigate the effect of dynamic balance exercises added to current medical treatment on balance in patients with ankylosing spondylitis.
详细描述
The study was planned as a randomized controlled study. Forty participants with a clinically confirmed diagnosis of AS according to ASAS criteria will be recruited from the PAU Department of Physical Medicine and Rehabilitation (PMR). These participants who meet the inclusion and exclusion criteria will be randomly divided into 2 groups.
The trial will be carried out at Pamukkale University Department of Physical Medicine and Rehabilitation between January 2024 and July 2025. The local ethics committee approved the study. All participants will be informed about the purpose and content of the study and will sign written consent to participate in the study.
Participant's age, gender, body mass index, education, occupation, medications, duration of diagnosis, comorbidity, functional status and pain will be questioned and recorded.
Group1: Group receiving dynamic balance exercise with tecnobody prokin 252 balance device added to current medical treatment (Intervention group) The first group will be given dynamic balance exercises with the tecnobody prokin 252 device and participants will continue their current medical treatment. These dynamic balance exercises will be performed in 3 days a week for 6 weeks. Each exercise will last 30 minutes. It will take 18 sessions in total. These exercises include 14 balance exercise movements performed on tecnobody prokin 252 balance device (manufactured in Italy).
Group 2: Group receiving current medical treatment (control group) Participants in this group will receive only current medical treatment. Care will be taken not to change the medical treatments of the participants during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 18 to 65 years with a clinical diagnosis of ankylosing spondylitis according to ASAS criteria
- •To have the ability to give written informed consent
- •Having the ability to understand procedures
排除标准
- •Visual and vestibular system diseases that may affect balance
- •Neurological or orthopedic diseases that may affect balance (Parkinson's disease, history of stroke, presence of knee or hip prosthesis, previous fracture sequelae, foot problems, etc.)
- •Individuals with severe mental and sensory problems
- •History of balance exercise and/or spine surgery in the last 6 months
- •Pregnancy or breastfeeding
- •Over 150 kg
结局指标
主要结局
Dynamic balance measurements
时间窗: 6 weeks after the start of rehabilitation
The TecnoBody Prokin 252 system was used to assess balance in the standing position for all participants. This equipment provides data on average track error and stability index.
次要结局
- Bath Ankylosing Spondylitis Metrology Index (BASMI)(6 weeks after the start of rehabilitation)
- ASQoL(6 weeks after the start of rehabilitation)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(6 weeks after the start of rehabilitation)
- Bath Ankylosing Spondylitis Functional Index (BASFI)(6 weeks after the start of rehabilitation)
研究者
Hakan Alkan
Clinical Professor
Pamukkale University