Investigating the Efficacy of Foot Sole Vibration on Balance and Physical Activity in People with Diabetic Peripheral Neuropathy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Postural Balance
研究概览
简要总结
The long-term effects of vibrating insoles on improving gait, balance and peripheral sensation in people with diabetic peripheral neuropathy remain unknown. The Pathfeel Clinical Trial will investigate the efficacy of vibratory insoles worn for ten days for enhancing sensory perception, gait quality, balance and physical activity in people with mild to severe diabetic neuropathy. The primary outcome will be changes in gait speed and postural and dynamic balance.
详细描述
The Path Feel Clinical Trial will investigate the efficacy of foot sole vibration applied for 10 days during daily life for improving peripheral sensation, balance and mobility in people with diabetic peripheral neuropathy.
Twenty-two people with mild to severe diabetic neuropathy will perform a prospective comparison where they wear an insole system over the course of two interventional periods of 10 days each in a randomised, cross-over design, during which there will be a period where the device provides vibrational stimuli, vs a control condition where the device is worn, but provides no stimuli. Any changes in activity levels, peripheral sensation, quality of life and balance control will be compared between each condition to determine the longer-term effects of foot sole vibration.
Each participant will undertake four study visits with periods of device use between them. Participants will complete a set of questionnaires that will assess quality of life (NeuroQoL) and fear of falling (FES-I). Measurements of the level of peripheral neuropathy will be taken at both feet using non-invasive methods, including a neurothesiometer (i.e., Vibration Perception Threshold) and a composite score (i.e., modified Neuropathy Disability Score). Gait, postural and dynamic balance during daily activities, including walking, stair walking will be assessed through a combination of 3D Motion Capture system and force platforms. Changes in physical activity will be quantified by accelerometry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of diabetes type 1 or 2
- •≥1 palpable foot pulses
- •Presence of mild to moderate diabetic peripheral neuropathy defined by a vibration perception threshold ≥15 Volts and/or mNDS score ≥
- •Aged ≥ 18 years
- •Ability to walk unaided for 30 steps
- •Able to understand the study requirements
- •Ability to check their feet regularly (or have another person check).
- •Able to read the study documents
- •Fit shoe size EU 36-47.5 / UK 3.5-13.
排除标准
- •Active foot ulcer
- •Lower limb amputation (anything more than amputation of two lesser toes)
- •Presence of Charcot deformity
- •Dementia or other cognitive impairment
- •Significant cardiopulmonary or other systemic disease limiting the patient's ability to walk 30 steps.
- •Person's with bodyweight greater than 130kg (due to insole device limitations)
- •Presence of implantable neurostimulators
- •Presence of a pacemaker.
研究组 & 干预措施
Vibration
Insoles with vibration
干预措施: Vibration on (Device)
No Vibration
Insoles without vibration
干预措施: Vibration off (Device)
结局指标
主要结局
Postural Balance
时间窗: Measurements were taken at four time points: at baseline, after 10 days of the first vibratory intervention, after a 10-day washout period, and at the end of the 10-day second vibratory intervention.
Centre-of-pressure velocity will be assessed using a force platform.
Gait speed during walking
时间窗: Measurements were taken at four time points: at baseline, after 10 days of the first vibratory intervention, after a 10-day washout period, and at the end of the 10-day second vibratory intervention.
Gait speed during level and stair walking will be assessed by 3D Motion Capture system.
次要结局
- Peripheral Sensation(Measurements were taken at four time points: at baseline, after 10 days of the first vibratory intervention, after a 10-day washout period, and at the end of the 10-day second vibratory intervention.)
- Peripheral Sensation 2(Measurements were taken at four time points: at baseline, after 10 days of the first vibratory intervention, after a 10-day washout period, and at the end of the 10-day second vibratory intervention.)