Effects of Sensomotoric Insoles on Postural Control in Elderly People - a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Posturographic measurement with Kistler's measuring plate
研究概览
简要总结
People with weak balance ability or subjective feeling of dizziness and unsure gait are separated into 3 training-groups. One Group is getting no insoles, the second group is getting modern sensomotoric insoles, and the third group is getting normal standard insoles. All are passing a 6 week proprioceptive training.
Main outcome measurements are posturography at baseline, 3 weeks and 6 weeks. Secondary measurements are ABC-Scale, Tinetti Gait and balance test and functional reach test at baseline and after 6 weeks.
详细描述
People with weak balance ability or subjective feeling of dizziness and unsure gait are separated into 3 training-groups. Exclusion criteria are structural neuropathic cause for dizziness, severe ocular deficience, cochlear causes for dizziness.
The 3 Groups differ in following criteria:
Group 1: Gets basic insoles after 3-D-Scan of the foot Group 2: Gets sensomotoric insoles (Jahrling) after 3-D-Scan of the foot. Group 3: Control-Group = no insoles
Alle groups are doing a 6 weeks proprioceptive training 2 times a week for 45min. Balance-Ability is measured by a posturographic plate prior to the training, after 3 weeks training and after 6 weeks of training. ABC-Score, Tinetti Gait and Balance test and functional reach test are secondary outcome measurements and are evaluated prior the training and after 6 weeks of training.
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
- None
盲法说明
Sensomotoric insoles and normal insoles or no insoles are not maskable.Patients and all involved persons will be able to easily see which type of insoles are used.
No blinding possible.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ABC-Scale < 70% Functional reach test < 30cm Subjective feeling of unsure gait or several falls in the last 5 years
排除标准
- •Structural pathologies in the balance system Neuropathologies like Polyneuropathy
研究组 & 干预措施
No insoles
Control group of people with poor postural control that won't use insoles
干预措施: No insoles (Other)
Normal insoles
Control group of people with poor postural control that will get normal standard insoles.
干预措施: normal standard insoles (Device)
Sensomotoric insoles
Control group of people with poor postural control that will get normal standard insoles.
干预措施: sensomotoric insoles (Device)
结局指标
主要结局
Posturographic measurement with Kistler's measuring plate
时间窗: 30 min.
a validated posturgraphy plate is measuring the balance ability
次要结局
- Tinetti Balance and Gait instrument(15 min.)
- Functional reach test(5 min)
- ABC-Scale(15 min)
研究者
PD Dr. Martin Weigl, MPH
Principal investigator
Ludwig-Maximilians - University of Munich