Determination of Cut-Off Values for Gait Variability and Balance Scores in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Limits of Stability
研究概览
简要总结
Purpose of the Study:
The aim of this study is to determine the cut-off values of gait variability and limits of stability-postural sways scores in patients with MS in order to identify fall risk at an early stage and take necessary precautions. Additionally, the study aims to compare the effectiveness of these parameters in distinguishing between fallers and non-fallers.
The study includes four hypotheses:
H₁: Gait variability scores can differentiate between fallers and non-fallers in patients with MS.
H₂: Limits of stability and postural sways scores can differentiate between fallers and non-fallers in patients with MS.
H₃: Gait variability scores provide higher sensitivity and specificity than stability limits and postural sway scores in distinguishing between fallers and non-fallers in patients with MS.
H₄: Limits of stability and postural sways scores provide higher sensitivity and specificity than gait variability scores in distinguishing between fallers and non-fallers in patients with MS.
详细描述
Gait variability will be assessed using the GaitRite gait analysis system. Limits of stability and postural sways will be evaluated using the Bertec Balance Check Screener™ force platform system. Patients' fall history (number of falls, fear of falling, location of falls, presence of injury, etc.) will also be questioned.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with MS by a neurologist according to the McDonald criteria
- •Aged 18 years or older
- •EDSS ≤ 5 (able to walk independently)
- •Mini-Mental State Examination score of 24 or higher
排除标准
- •Patients with neurological conditions other than MS that may affect independent walking or standing, those with lower extremity pain, or a history of lower extremity fractures within the past 6 months
- •Patients who do not agree to participate or do not provide written informed consent will be excluded from the study.
研究组 & 干预措施
Multiple Sclerosis
• Patients diagnosed with MS by a neurologist according to the McDonald criteria, aged 18 years or older, having an EDSS score of ≤ 5 (able to walk independently), and having a Mini-Mental State Examination score of 24 or higher will be included in the study.
结局指标
主要结局
Limits of Stability
时间窗: up to 5 months
Limits of stability assessment will be conducted using the Bertec Balance Check Screener™ force platform system (45×45 cm, 13 cm thick), which detects body movements via foot pressure.Limits of stability will be measured by asking participants to lean maximally in four directions (forward, backward, right, left) without losing balance. Stability scores (in cm and %) will be calculated using Balance Check Software.
Postural sways
时间窗: up to 5 months
Postural sways assessment will be conducted using the Bertec Balance Check Screener™ force platform system (45×45 cm, 13 cm thick), which detects body movements via foot pressure. A foam pad of the same size is used to assess postural sway. Postural sways will be evaluated under four conditions (eyes open/closed on firm/foam surfaces). Participants will stand still for 10 seconds per condition, repeated three times. The average stability score (%) will be recorded for each condition.
Gait variability
时间窗: up to 5 months
Gait variability will be performed using the GAITRite® system, a 4.6-meter portable walkway mat embedded with pressure sensors that record step data without interfering with the natural gait. Participants will walk naturally across the mat three times; the average of the trials will be analyzed. Gait variability will be expressed as the coefficient of variation (CV) (%). Using this formula: CV (%) = (standard deviation/mean) × 100.
Fall Histories
时间窗: up to 5 months
The following fall-related information will be recorded: Number of Falls Cause of Fall Time of Fall Activity During Which the Fall Occurred Type of Fall Fall-Related Injury / If Present, Type of Injury
次要结局
未报告次要终点
研究者
Güngör Beyza ÖZVAR
Principal Investigator
Hacettepe University