Peripheral Magnetic Stimulation With Balance Training to Decrease Fall Risks in Older Patients With Diabetic Polyneuropathy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- One-leg standing balance test (OLST)
研究概览
简要总结
This study aims to determine whether peripheral magnetic stimulation (PMS) during balance training in patients with diabetic polyneuropathy reduces fall risk, as measured by balance tests, and lessens disease severity compared to balance training with sham stimulation.
This proof-of-concept study will utilize the Magnetic and Balance Training Activator (MAGBATA), a platform mounted with a magnetic stimulation coil that delivers electromagnetic pulses directly to the plantar surfaces of the feet while patients stand. A racetrack coil (RT-120), connected to the MagPro X100 magnetic stimulator with MagOption (MagVenture, Farum, Denmark), will be used. Parameters for the repetitive peripheral magnetic stimulation (rPMS) protocol will be configured to facilitate sensory input, enhance brain plasticity, and promote axonal regeneration.
详细描述
This single-center randomized controlled trial will use a two-group parallel design and include 40 patients with diabetic polyneuropathy who meet the eligibility criteria. Participants will be randomly assigned to either the active intervention group or the control group.
The active intervention group will receive a warm-up exercise consisting of 25 repetitions of ankle dorsiflexion with concurrent 10 Hz rPMS applied to the tibialis anterior of each leg. Following the warm-up, participants will stand on the MAGBATA platform and perform 20 cycles of one-leg stance exercises under the supervision of a physiotherapist. Each cycle lasts 20 seconds and consists of 3 seconds of 20 Hz rPMS applied to the plantar surface of the foot while the participant stands on one leg, followed by 12 seconds of rest during which the participant stands on both legs. The same sequence will then be repeated for the other leg. Stimulation intensity will be determined prior to the warm-up. The coil will be placed over the tibialis anterior to determine the minimal contraction threshold (MCT), defined as the lowest intensity that produces a visible contraction. The stimulation intensity will be set at 110% of the MCT for the warm-up exercise and 120% for the treatment during balance exercises.
The control group will receive the same procedure, but with sham stimulation during both the warm-up and one-leg stance phases.
The intervention will consist of 8 sessions, conducted twice per week with at least one day of rest between sessions. Outcome assessments include one-leg stance test (OLST) with eyes open, timed up and go test (TUGT), and short physical performance battery (SPPB); these assessments will be conducted at baseline and after the 4-week intervention. Additionally, a rehabilitation physician, blinded to group allocation, will perform electrophysiologic studies at baseline and week 8 to assess disease severity. These studies will include bilateral measurements of sural nerve amplitude and conduction velocity, tibial compound motor action potential (CMAP) amplitude and conduction velocity, and tibial F-wave latency.
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)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus type 2 with any symptoms of distal polyneuropathy, including numbness, paresthesia, dysesthesia, or lower leg weakness.
- •Abnormal 10g monofilament test.
- •Abnormal one-leg stance test (OLST) with eyes open.
排除标准
- •Chronic foot ulceration.
- •Severe leg or foot pain not controllable with medications or other interventions.
- •Significant foot deformity, including severe pes cavus, severe claw toe, or toe amputation.
- •Body mass index (BMI) over 35 kg/m².
- •Visual acuity less than 20/100 after correction with glasses or contact lenses.
- •Postural instability or coordination disorders resulting from musculoskeletal, vestibular, or central nervous system conditions.
- •Symptoms such as confusion, drowsiness, dizziness, or a high risk of falls due to any disease or recent medication changes within a two-week period.
- •Presence of cardiac pacemaker, knee prosthesis, or metal implants in the lower legs.
- •Inability to walk or stand for at least 5 minutes.
- •Inability to understand, comprehend, or follow instructions required to conduct the study, or to provide informed consent.
研究组 & 干预措施
Peripheral magnetic stimulation with balance training (rPMS-BT)
The participants will undergo a warm-up exercise involving ankle dorsiflexion, with concurrent rPMS applied to the tibialis anterior of each leg. Following the warm-up, participants will stand on the MAGBATA platform and perform one-leg stance exercises while rPMS is applied to the plantar surface of the foot. This procedure will be repeated for the other leg.
干预措施: Balance training (Behavioral)
Peripheral magnetic stimulation with balance training (rPMS-BT)
The participants will undergo a warm-up exercise involving ankle dorsiflexion, with concurrent rPMS applied to the tibialis anterior of each leg. Following the warm-up, participants will stand on the MAGBATA platform and perform one-leg stance exercises while rPMS is applied to the plantar surface of the foot. This procedure will be repeated for the other leg.
干预措施: Peripheral magnetic stimulation (Device)
Sham stimulation with balance training (Sham-BT)
The sham comparator group will receive the same procedure as the interventional group, but with sham stimulation during both the warm-up and one-leg stance exercise.
干预措施: Balance training (Behavioral)
Sham stimulation with balance training (Sham-BT)
The sham comparator group will receive the same procedure as the interventional group, but with sham stimulation during both the warm-up and one-leg stance exercise.
干预措施: Sham stimulation (Other)
结局指标
主要结局
One-leg standing balance test (OLST)
时间窗: From enrollment to the end of treatment (week 4).
Participants stand on the floor with their eyes open and arms relaxed at the sides of the body. They are instructed to lift the opposite foot off the floor, flex the knee to 90 degrees, and position the lifted foot behind the body, maintaining balance on the tested leg for as long as possible. The assessor begins timing when the participant's foot leaves the floor and stops timing if the participant sways, extends either arm to maintain balance, or successfully holds the position for 30 seconds. The test is then repeated on the opposite leg. The durations from each legs are reported in seconds.
次要结局
- Nerve conduction study(From enrollment to week 8.)
- Timed up and go test (TUGT)(From enrollment to the end of treatment (week 4).)
- Short physical performance battery (SPPB)(From enrollment to the end of treatment (week 4).)
研究者
Komwudh Konchalard
Physiatrist, Department of Rehabilitation Medicine
Queen Savang Vadhana Memorial Hospital, Thailand