Effects of Functional Magnetic Stimulation on Sensory, Motor, and Functional Outcomes in Individuals With Diabetic Peripheral Neuropathy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change From Baseline in Timed Up and Go Completion Time
研究概览
简要总结
This study evaluated whether a 2-week course of functional magnetic stimulation applied to the plantar region of the foot could improve sensory function, foot muscle force, postural control, and functional mobility in adults with type 2 diabetes mellitus and diabetic peripheral neuropathy. Participants were assigned to active functional magnetic stimulation or sham stimulation. The study hypothesis was that repeated functional magnetic stimulation would improve sensory and motor function and lead to better functional performance compared with sham stimulation.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants in the sham group underwent the same positioning, session duration, and treatment procedures as participants receiving active stimulation. A metal plate was positioned between the support plate and magnetic stimulation head to shield or substantially attenuate the magnetic field while preserving the external appearance and procedural experience of treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with type 2 diabetes mellitus and diabetic peripheral polyneuropathy documented in their medical records
- •Ability to walk independently with or without an assistive device
- •Ability to understand and follow study procedures
排除标准
- •Conditions that could independently affect balance or foot function
- •Contraindications to magnetic stimulation
- •Active foot ulceration
- •Recent lower-limb injury or surgery
- •Severe neurological or musculoskeletal disease unrelated to diabetic peripheral neuropathy
- •Cognitive impairment preventing valid participation
研究组 & 干预措施
Functional Magnetic Stimulation
Participants received functional magnetic stimulation applied to the plantar region of the foot using the FMS Stym device. Treatment consisted of 12 sessions over 2 weeks, with each session lasting 20 minutes. The manufacturer's preset peripheral neuropathy program was used. Stimulation was continuous and intensity was individually adjusted to produce visible contractions of the intrinsic foot muscles while remaining comfortable.
干预措施: Functional Magnetic Stimulation (Device)
Sham Functional Magnetic Stimulation
Participants underwent the same positioning, treatment schedule, and session procedures as the active stimulation group. A metal plate was placed between the upper support plate and magnetic stimulation head to shield or substantially attenuate the magnetic field reaching the foot. Sessions lasted 20 minutes and were performed 12 times over 2 weeks.
干预措施: Sham Functional Magnetic Stimulation (Device)
结局指标
主要结局
Change From Baseline in Timed Up and Go Completion Time
时间窗: Baseline and after 2 weeks of intervention (after 12 sessions)
Participants rose from a chair, walked 3.6 m, turned, walked back to the chair, and sat down. Completion time was recorded in seconds. Lower values indicate better functional mobility.
Change From Baseline in Hallux Grip Force Assessed With the Enhanced Paper Grip Test
时间窗: Baseline and after 2 weeks of intervention (after 12 sessions)
Hallux grip force was measured in Newtons using the Enhanced Paper Grip Test. Three measurements were performed for each foot, and the outcome was the average across both feet and three trials. Higher values indicate greater foot grip force.
次要结局
- Change From Baseline in Center-of-Pressure Sway Velocity(Baseline and after 2 weeks of intervention (after 12 sessions))
- Change From Baseline in Semmes-Weinstein Monofilament Total Score(Baseline and after 2 weeks of intervention (after 12 sessions))
- Change From Baseline in Vibration Perception Threshold(Baseline and after 2 weeks of intervention (after 12 sessions))
研究者
Nejc Sarabon
Prof. dr.
University of Primorska