Effects of Stabilization Shoes on Balance and Walking. A Cross-over, Controlled, Randomized Single Blind Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Assessing change of the displacement surface of the center of pressure between the three sessions during static balance on a foot with open eyes
研究概览
简要总结
Movement during everyday activities most often requires stable posture. Postural control corresponds to a complex motor ability to maintain / re-establish balance and orient one's body in the environment. Postural stability and equilibrium deteriorate with age. More than 30% of people over 65 years old fall per year. Falls represent 90% of hip fractures and sometimes result in lasting psychological effects. Shoes are our direct link between the ground and our feet. Wearing shoes plays a major role in postural control. The characteristics of shoes usually worn by elderly people are identified with those of shoes known to be 'dangerous'. In order to improve stability and reduce the risk of falling for the elderly, Axis-Comfort Development® has developed "experimental balance shoes". Their shoes have technical characteristics presented in the scientific literature as beneficial for postural stability.
Therefore, the aim of this study was to investigate the effects of wearing experimental balance shoes on postural balance compared with the people's own shoes. We assumed that postural balance would be improved by experimental balance shoes in an acute way and improved by a familiarization phase.
This was a controlled, randomized, blind and cross-over study. three sessions were held in our center, each time interspersed with a phase of familiarization at home (7 to 10 days) during which the people had to wear either the experimental balance shoes or their own personal shoes. 21 volunteers in total participated in this study, all between 65 and 75 years old. Five tests were presented randomly for each session and all tests were carried out on a Huber 360 ® (LPG System, France) stabilometric platform. The mains criteria were static equilibrium on one foot and two feet (with eyes open and closed) and secondary criteria were stride frequency during the walk on the spot and stability limits.
An improvement of these multiple criteria during the different sessions would be proof of the positive effect of experimental balance shoes on postural balance in the elderly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data and statistical analyses
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects from 65 to 75 years old
- •Healthy subjects
- •Having given their written informed consent
排除标准
- •Subject who has fallen during the six months prior to the study.
- •Subject who moves with walking aids.
- •Subject with severe balance problems or unable to stand up without help
- •Subject who takes sedatives or sleeping pills
- •Subject with neurological disease (dizziness including turning dizziness, multiple sclerosis, Parkinson's, etc.)
- •Subject with history of heart attack
- •Subject who is short of breath when inactive.
- •Subject who has pains limiting walking and standing
- •Subject who takes neuroleptics except Anti-depressors if the treatment is long-standing and well-balanced.
结局指标
主要结局
Assessing change of the displacement surface of the center of pressure between the three sessions during static balance on a foot with open eyes
时间窗: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Surface of the displacement of the centre of pressure (Value in square millimeters, mm²) during 30 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Assessing change of the length of the displacement of the centre of pressure between the three sessions during static balance on a foot with open eyes
时间窗: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Length of the displacement of the centre of pressure (Value in millimeters, mm) during 30 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Assessing change of the length of the displacement of the centre of pressure between the three sessions during static balance on two feet open eyes
时间窗: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Length of the displacement of the centre of pressure (Value in millimeters, mm) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Assessing change of the number of rebalancing gestures between the three sessions during static balance on two feet open eyes
时间窗: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Number of rebalancing gestures (with the foot or with the hand during test) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Assessing change of the number of rebalancing gestures between the three sessions during static balance on a foot with open eyes
时间窗: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Number of rebalancing gestures (with the foot or with the hand during test) during 30 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Assessing change of the displacement surface of the center of pressure between the three sessions during static balance on two feet open eyes
时间窗: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Surface of the displacement of the centre of pressure (Value in square millimeters, mm²) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
Assessing change of the average speed of the displacement of the centre of pressure between the three sessions during static balance on two feet open eyes
时间窗: Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session
Average speed of the displacement of the centre of pressure (Value in millimeters per second, mm/s) during 50 seconds was measured on a Huber 360 ® (LPG System, France) force platform.
次要结局
- Assessing change in stability limits between the three sessions at 225°(Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session)
- Assessing change in walking capacity between the three sessions(Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session)
- Assessing change in stability limits between the three sessions at 0°(Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session)
- Assessing change in stability limits between the three sessions at 45°(Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session)
- Assessing change in stability limits between the three sessions at 135°(Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session)
- Assessing change in stability limits between the three sessions at 90°(Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session)
- Assessing change in stability limits between the three sessions at 270°(Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session)
- Subjective assessment of the comfort linked to the wearing of the experimental balance shoes(Measured after wearing experimental balance shoes for a week (familiarization's period))
- Subjective assessment of the stability linked to wearing of the experimental balance shoes(Measured after wearing experimental balance shoes for a week (familiarization's period))
- Assessing change in stability limits between the three sessions at 180°(Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session)
- Assessing change in stability limits between the three sessions at 315°(Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session)
- Subjective assessment of the aesthetics linked to wearing of the experimental balance shoes(Measured after wearing experimental balance shoes for a week (familiarization's period))
- Subjective assessment of the safety linked to wearing of the experimental balance shoes(Measured after wearing experimental balance shoes for a week (familiarization's period))
- Assessing change of the displacement surface of the center of pressure between the three sessions during static balance on two feet closed eyes(Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session)
- Assessing change of the length of the displacement of the centre of pressure between the three sessions during static balance on two feet closed eyes(Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session)
- Assessing change of the average speed of the displacement of the centre of pressure between the three sessions during static balance on two feet open eyes(Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session)
- Assessing change of the number of rebalancing gestures between the three sessions during static balance on two feet open eyes(Measure during the three sessions and for both conditions (balance or personal). 1 minute recovery between tests. 7 to 10 days between the three sessions (familiarization). Test appearance order is random for each session)
研究者
Nicolas Babault
Principal investigator
University of Burgundy