Effects of the Pressure and Traction Technique on the Plantar Footprint and Balance Against a Placebo Laser: A Randomized Single Blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- static footprint
研究概览
简要总结
The aim of this clinical trial is to check the effects of manual pressure and traction technique on balance and plantar footprint variables comparing with Laser placebo.
详细描述
Forty healthy subjects wil be recruited for a simple blind study. Participants will be from 1 to 40 years old, not obese. Participants will be randomized into two groups. Experimental group performed a bilateral plantar fascia manual pressure and traction technique. Control group performed a laser placebo. The time duration (5 minutes), position, and therapist were the same for both treatments. The investigators will measure stabilometry variables and static footprint. The footprint variables will be divided in bilateral rear foot, bilateral midfoot, bilateral fore foot.
Measures. Stabilometry will be measured by displacement of the center of pressures in X and Y with eyes open and closed , center of pressure (COP) with eyes open and closed, COP area with eyes open and closed, COP antero-posterior (a-p) and medio-lateral (m-lat) directions with eyes open and closed, and COP speed. Two trials will be recorded for each condition and the order of the conditions will be randomized across subjects, eyes open and eyes closed. Foot plantar pressure and surface area of two static footprints will be measured during bipedal standing. Static plantar pressure will be evaluated by means of maximum pressure, medium pressure and surface area of each aspect of the foot (rearfoot, midfoot, and fore foot).
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
- Single (Participant)
盲法说明
single blind masking
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals
- •Must have no pain
排除标准
- •Previous lower extremities surgery.
- •History of lower extremities injury with residual symptoms (pain, "giving-away" sensations) within the last year.
- •Leg-length discrepancy more than 1 cm
- •Balance deficits (determined by oral questionnaire regarding falls)
结局指标
主要结局
static footprint
时间窗: Through study completion, an average of 1 month
Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline
stabilometry variables eyes closed
时间窗: Through study completion, an average of 1 month
Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform (27), participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. During all the examinations, the upper limbs were placed in a relaxed position along the body. The subjects were instructed to stand as still as possible for 30 s, with their eyes open, while concentrating on a point at eye level 2-m away or with their eyes closed
stabilometry variables eyes open
时间窗: Through study completion, an average of 1 month
Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform (27), participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. During all the examinations, the upper limbs were placed in a relaxed position along the body. The subjects were instructed to stand as still as possible for 30 s, with their eyes open, while concentrating on a point at eye level 2-m away or with their eyes open
次要结局
- stabilometry variables eyes open after intervention(Through study completion, an average of 1 month)
- static footprint after intervention(Through study completion, an average of 1 month)
- stabilometry variables eyes after intervention(Through study completion, an average of 1 month)
研究者
EVA MARIA MARTÍNEZ JIMENEZ
Head of Podiatry, Principal Investigator, and Physiotherapist
Mayuben Private Clinic