Influence of Podal Sensory Information on Static and Locomotion, Using Foam and Orthopaedic Insoles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Center of Pressure measurement between conditions
研究概览
简要总结
Sensory foot integration is evaluated by foam under feet both in research and clinical contexts. However, there is no norm defined regarding foam characteristics and this evaluation is mostly performed using a static task. Our goal is to better understand the impact of the modification of plantar information by foam both during static task and locomotion task. The purpose is to standardize evaluation methods and define reference values for a better follow-up and diagnosis of patients.
详细描述
The foot is a fundamental area of interaction with the environment. To understand and quantify the importance of plantar information for balance control, researchers characterized plantar sensors and evaluated the motor adaptations induced by disrupting the sensory feedback of this information via different techniques: electrostimulation, vibration, anesthesia, mechanical stimulation (Bent, 2015). Mechanical stimulation is non-invasive and uses material of different characteristics. In most cases, it is a foam plate or an orthopedic insole (composed of predefined reliefs).
In clinical practice, the foam is used to assess the foot ability to adapt to the correction of the orthopedic insoles. A patient stands still on a force plate which records Center of Pressure (CoP) position. The CoP oscillations with and without the foam are compared using the Plantar Quotient (PQ). PQ is the ratio between the oscillation surface of the CoP on the foam and the oscillation surface of the CoP without foam. A podal postural inefficiency is then defined by a PQ >100% meaning that their balance is improved with the interposition of a foam. However, there is no consensual characteristics about the height or the density of the foam.
In addition, postural evaluation with mechanical stimulation was previously done exclusively in this static mode, which does not represent an ecological reality of daily life activities. The effect of thin orthopedic elements has never been quantified during a locomotor task.
In this context, our project has two objectives, that will be addressed through two experimental studies. The first objective is to relate the effect of foam characteristics and postural stability. Understanding the standard postural response will allow to identify patients with a podal postural inefficiency. The second objective is to evaluate the effect of a sole element on the statics and locomotion of healthy participants compared to ineffective podal postural participants (determined via the calculation of the PQ detailed previously with the foams analyzed in the first study).
We will perform clinical tests carried out in a daily podiatry practice adding motion capture to consider dynamic situations more precisely. The study is interventional (non-invasive) and non-permanent due to the interposition of thin foam plate (less than 1 cm thick) and sole elements (3 mm thick) under the feet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
盲法说明
Participants will be exposed to different foams under their feet but neither them, nor the investigator are aware of the expected differences in the effect of the foams.
In the second part, neither the participant, nor the investigator know the result of the first experiment.
入排标准
- 年龄范围
- 18 Years 至 59 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •between 18 to 59 years
- •Healthy subject
排除标准
- •balance disorders
- •be pregnant
- •be in rehabilitation of the lower limb
- •have a lower limb injury within the 3 last months
研究组 & 干预措施
Mechanical foot stimulation evaluation
We have a 2 factors' interaction (vision and foot) with several levels.
- foot: 4 levels =3 foams and a Control (CT) condition)
- vision: 2 levels (open/close) A test will consist of maintaining a standing position on a stabilometric platform for 30s in a given condition. 3 trials are performed for each condition (combination of different levels) Between each trial: the subject is asked to self evaluate his stability. We evaluate the plantar discrimination with a discrimination disk. 5 foot zones are tested.
3/5 subjects from PIMOUSS1 are asked to be in PIMOUSS2. We have the interaction of 2 factors. foot: 2 levels (insole/CT) vision : 2 levels (open/close) A trial is the combination of the different levels while walking. It is repeated 5 times per condition.
The participant will perform this task under several experimental conditions presented in a randomized order:
- Trajectory: (straight ahead/90° turns)
- Visual: (close/open)
- Mechanical stimuli (CT/insole)
干预措施: Foams (Other)
Mechanical foot stimulation evaluation
We have a 2 factors' interaction (vision and foot) with several levels.
- foot: 4 levels =3 foams and a Control (CT) condition)
- vision: 2 levels (open/close) A test will consist of maintaining a standing position on a stabilometric platform for 30s in a given condition. 3 trials are performed for each condition (combination of different levels) Between each trial: the subject is asked to self evaluate his stability. We evaluate the plantar discrimination with a discrimination disk. 5 foot zones are tested.
3/5 subjects from PIMOUSS1 are asked to be in PIMOUSS2. We have the interaction of 2 factors. foot: 2 levels (insole/CT) vision : 2 levels (open/close) A trial is the combination of the different levels while walking. It is repeated 5 times per condition.
The participant will perform this task under several experimental conditions presented in a randomized order:
- Trajectory: (straight ahead/90° turns)
- Visual: (close/open)
- Mechanical stimuli (CT/insole)
干预措施: Foam / Orthopedic insole (Other)
结局指标
主要结局
Center of Pressure measurement between conditions
时间窗: 30 seconds
Characteristics of centre of Pressure (CoP) will be registered for every 30s trial. The CoP movement during this 30s will be describe with its aera, velocity... A within analysis will be perform between the 3 repetitions for each condition. A between analysis will be performed between the foot conditions.
Center of Mass (CoM) measurement between condition
时间窗: Clinical assessment at baseline
CoM projection will be analysed regarding foot position during locomotion We will compare control condition to insole condition
Plantar Quotient on CoP
时间窗: 30 seconds
The plantar quotient is the ratio of the oscillation of CoP on foam to the oscillation of CoP on hard ground. It will be calculated for each foam. It will be calculating using aera data and velocity data.
次要结局
- Stability self evaluation(Clinical assessment at baseline)
- Plantar discrimination disk(Clinical assessment at baseline)
研究者
Carole PUIL
PhD student
University of Rennes 2
