Walking With the SAIRE Smart Walker
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- 3D kinematic measurements of the lower limb
研究概览
简要总结
The current study aims to investigate the effect of walking with the SAIRE smart walker on spatiotemporal parameters and gait kinematics in a population who suffer from difficulties during gait, and compare this to walking with a standard walker or no walking aid.
详细描述
This study is an experimental single group study investigating the effect of walking with a smart walker compared to walking with a standard walker or no walking aid in persons who suffer from gait difficulties. Participants will perform one session of walking in three different conditions, (1) walking with the SAIRE smart walker, (2) walking with a standard walker and (3) if the participants are able to walk without the use of an assistive device, walking without a walker. During this session, gait parameters will be compared between the three conditions.
Experimental session: During the experimental session, participants will walk along the 10-meter walkway (5 times for every condition) After every 5 trials, a rest period of minimum 5 minutes will be held to avoid fatigue. Three different walking conditions will be measured: (1) walking with the SAIRE smart walker, (2) walking with a standard walker and if possible (3) walking with no walking aid. Each walking condition will be measured five consecutive times in a randomized order. The order of the conditions will be randomized using closed envelopes containing notes that say what order of conditions will be used. This randomization is done to avoid fatigue effects that might occur when a strict order is used.
Before the start of the experimental session, participants will practice using the SAIRE smart walker for maximum 10 minutes to familiarize with the feedback given by the walker. After this familiarization session, the surface electrodes and reflective markers will be placed on the participants and the experimental session will start.
Analysis: This study will investigate the difference in gait biomechanics of adults with gait difficulties while using different walking aids.
Descriptive statistics of the baseline characteristics of all participants will be performed. The effect of gait with a smart walker on spatiotemporal gait parameters, kinematics and muscle activity will be compared to gait with a standard 2-wheeled walker and gait without a walking aid. Data will be visualized using LO(W)ESS smoothing (locally weighted scatterplot smoothing) to explore the effect (per condition and outcome). Values will be compared between conditions in a one-way repeated measures analysis of variance. For the analysis of the USE questionnaire, percentage distribution of every item and mean scores for every subscale will be calculated using Microsoft Excel (Microsoft, Washington, DC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to walk along a 10-meter walkway multiple times over a period of 120 minutes
- •Ambulation with any sort of assistive device (e.g. cane, crutches, walker, etc.)
- •Sufficient arm/hand function to walk with a walker
- •Capable of understanding and carrying out instructions
- •Capable of giving informed consent
排除标准
- •Presence of cognitive impairement (MoCA score <23)
结局指标
主要结局
3D kinematic measurements of the lower limb
时间窗: At the end of the experimental session, Day 1
Kinematic data (i.e., movement amplitudes of the bilateral hip, knee and ankle joint) of the lower limbs during walking will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Stance time
时间窗: At the end of the experimental session, Day 1
Stance time of the lower limbs during walking will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Double limb support period
时间窗: At the end of the experimental session, Day 1
Double limb support period will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Electromyography
时间窗: At the end of the experimental session, Day 1
Muscle activity of the lower limb muscles (bilateral: M. rectus femoris, M. vastus lateralis, M. biceps femoris, M. tibialis anterior, M. gastrocnemius medialis) will be recorded continuously during treadmill walking with the use of surface electrodes. Signals will be recorded with the wireless Cometa Wave Plus EMG system (16 channels).
Step length
时间窗: At the end of the experimental session, Day 1
Step length will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Step time
时间窗: At the end of the experimental session, Day 1
Step time will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Walking speed
时间窗: At the end of the experimental session, Day 1
Walking speed will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Swing time of the lower limbs
时间窗: At the end of the experimental session, Day 1
Swing time of the lower limbs during walking will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Cadence
时间窗: At the end of the experimental session, Day 1
Cadence will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Single limb support period
时间窗: At the end of the experimental session, Day 1
Single limb support period will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
次要结局
- User experience with a modified version of the USE questionnaire(At the end of the experimental session, Day 1)
研究者
Ruben Debeuf
Principal investigator
Vrije Universiteit Brussel