Gait Stability After Stroke (AdaptGait)
Influence of Added Tasks and Different Environmental Conditions on Gait Stability After Stroke
The study will investigate gait stability in individuals post-stroke compared with age- and sex-matched healthy adults. Participants will undergo laboratory-based walking assessments under different environmental conditions, including level walking, uphill and downhill walking, and unexpected slip perturbations, with and without added cognitive, postural, and load-carrying tasks. The primary outcome measures will be the Margin of Stability (MOS), step width, and step width variability.
研究概览
地位
条件
详细说明
: The study will recruit 20-30 adults post-stroke and an equal number of healthy controls. Participants post-stroke will be recruited after discharge from their regular rehabilitation. Participants will complete a single assessment session involving walking on a instrumented dual-belt treadmill mounted on a Stewart platform while secured with a safety harness. Walking conditions will include level, inclined, declined, and slip-perturbed walking, as well as walking combined with serial subtraction, head turning, or backpack carrying. Three-dimensional motion capture, force measurements, and surface electromyography will be used to quantify gait biomechanics and neuromuscular responses. The effects of environmental conditions and added tasks on gait stability, balance control, and fall risk will be compared between groups to identify biomechanical and neuromuscular markers associated with increased fall susceptibility after stroke.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Katja Groleger Sršen, MD, PhD
- 电话号码:+386 1 4758283
- 邮箱:katja.groleger@ir-rs.si
学习地点
-
-
-
Ljubljana、斯洛文尼亚、1000
- University Rehabilitation Institute, Republic of Slovenia
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria - stroke group:
- Discharge from regular rehabilitation
- First unilateral ischemic or hemorrhagic stroke affecting one of the cerebral hemispheres
- More than 3 months post-stroke
- Mini-Mental State Examination score ≥24 or cognitive ability to participate in the study
- Ability to walk independently in the community without a walking aid
- Moderate to mild balance impairment (Mini-BESTest score 16-25)
- Sufficient cognitive and physical ability to participate
- Ability to walk on a treadmill in intervals for up to 30 altogether
Inclusion Criteria - healthy control group:
- Age- and sex-matched to participants with stroke
- Mini-BESTest score ≥ 16
- Sufficient cognitive and physical ability to participate
- Ability to walk on a treadmill in intervals for up to 30 altogether
Exclusion Criteria (both groups):
- Musculoskeletal impairments affecting gait or balance
- Severe cardiovascular disease or heart failure (NYHA Class III-IV)
- Other neurological disorders
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Post-stroke patients
Adults with unilateral stroke (>3 months post-stroke) will undergo assessment of gait stability and balance responses during treadmill walking under different environmental conditions (level, uphill, downhill, and slip-perturbed walking) and added tasks (serial subtraction, head turning, and backpack carrying). |
Level treadmill walking Uphill treadmill walking Downhill treadmill walking Slip-perturbed treadmill walking Added task: serial subtraction Added task: head turning Added task: backpack carrying |
|
有源比较器:Control group: healthy control participants
Age- and sex-matched healthy adults will undergo the same assessment protocol as the post-stroke patients, i.e., assessment of gait stability and balance responses during treadmill walking under different environmental conditions (level, uphill, downhill, and slip-perturbed walking) and added tasks (serial subtraction, head turning, and backpack carrying). |
Level treadmill walking Uphill treadmill walking Downhill treadmill walking Slip-perturbed treadmill walking Added task: serial subtraction Added task: head turning Added task: backpack carrying |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Margin of Stability (MOS)
大体时间:During the intervention (periprocedurally)
|
Margin of stability in the anteroposterior and mediolateral directions calculated from kinematic and kinetic gait data during walking under different environmental conditions and added tasks, expressed in cm (more is better) |
During the intervention (periprocedurally)
|
|
Step Width
大体时间:During the intervention (periprocedurally)
|
Mean step width measured during walking under different environmental conditions and added tasks, expressed in cm (less is better) |
During the intervention (periprocedurally)
|
|
Step Width Variability
大体时间:During the intervention (periprocedurally)
|
Variability of step width calculated across consecutive gait cycles during walking under different environmental conditions and added tasks, , expressed as coeffcient of variation (less is better) |
During the intervention (periprocedurally)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Spatiotemporal Gait Parameter 1: Cadence
大体时间:During the intervention (periprocedurally)
|
Gait cadence (in steps/min; less is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
|
|
Spatiotemporal Gait Parameter 2: Step Length
大体时间:During the intervention (periprocedurally)
|
Gait step length (in cm, more is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
|
|
Spatiotemporal Gait Parameter 3: Stance Time
大体时间:During the intervention (periprocedurally)
|
Gait stance time (in s, less is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
|
|
Spatiotemporal Gait Parameter 4: Swing Time
大体时间:During the intervention (periprocedurally)
|
Gait swing time (in cm, more is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
|
|
Kinetic Variable 1: Ground Reaction Force
大体时间:During the intervention (periprocedurally)
|
Ground reaction force in antero-posterior direction (in N; less is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
|
|
Kinetic Variable 2: Center-of-pressure Movement
大体时间:During the intervention (periprocedurally)
|
Center-of-pressure movement in antero-posterior and medio-lateral direction (in cm; less is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
|
|
Kinetic Variable 3: Velocity
大体时间:During the intervention (periprocedurally)
|
Velocity in antero-posterior and medio-lateral direction (in cm/s; smaller is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
|
合作者和调查者
调查人员
- 首席研究员:Metka Močilar, MSc PT、University Rehabilitation Institute, Republic of Slovenia
- 研究主任:Urška Puh, PT, PhD、University Rehabilitation Institute, Republic of Slovenia
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.