Portable Neuromodulation Stimulator (PoNS®) Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Primary safety endpoints
研究概览
简要总结
Double blind, randomized, placebo controlled, interventional clinical trial investigating the efficacy and safety of PoNS therapy on improving dynamic gait and balance deficits in chronic stroke survivors.
详细描述
Double blind, randomized, placebo controlled, interventional clinical trial investigating the efficacy and safety of PoNS therapy on improving dynamic gait and balance deficits in chronic stroke survivors.
The Study Intervention Therapy is a therapeutic rehabilitation program that uses the PoNS device, Active or Sham, in conjunction with individualized physical exercise regimen.
The data from this prospective, double-arm, multi-site study that will enroll 40 subjects at 2-3 different clinical sites will be used to augment efficacy and safety data obtained in the RCT (which will randomize 60 subjects 1:1 into either active PoNS combined with DGB training versus DGB training with a sham device) and the OLS (which will enroll 30 subject into one active treatment arm). The totality of the proposed clinical evidence spans 3-4 sites and approximately 120 participants.
Eligible study participants will be randomized to either active PoNS ["Study Intervention"] device ["active"] or placebo PoNS ["Study Intervention"] device ["sham"]. Participants will work with a study physical therapist - trained in PoNS Therapy by HMI Medical and registered as a PoNS Trainer (Trainer).
The Trainer will prepare a DGB training exercise program appropriate to the participant's ability level and instruct on how to perform the breathing and awareness (mindfulness) training (BAT). To ensure patient's safety during rehabilitation at home, the Trainer may assign a DGB training program slightly different from the one performed in clinic.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The active Study Intervention device will deliver high-pulse stimulation and the sham Study Intervention device will deliver no-pulse stimulation although participants will be instructed to not assume being assigned an active or sham device based on whether they can feel the stimulation in the tongue or not.
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
- •Men and women ≥ 18 and < 85 years of age with a diagnosis ischemic or hemorrhagic stroke at > 6 months since stroke onset event.
- •FMA-LE scores < 34 at screening with residual paresis in the lower extremity.
- •Able to walk at least 10 feet with or without assistive device.
- •FGA score < 23 at screening.
- •Montreal Cognitive Assessment 5-min (MoCA 5-min) ≥ 6
- •Able to understand, learn and apply instructions on how to operate the PoNS device and perform the rehabilitation exercise program.
排除标准
- •Pre-existing neurological disorders or previous stroke affecting the other hemisphere.
- •Severe arthritis or orthopedic problems that limit passive range of motion.
- •Areas of recent bleeding or open wounds; or areas that lack normal sensation on the tongue.
- •Diagnosis of dementia or mild cognitive impairment
- •Concurrent daily use of transcutaneous electric nerve stimulation (TENS) and/or other peripheral stimulation devices (i.e. Bioness®)
- •Neurostimulation therapy over the previous 6 months
- •Cancer treatment within the past year.
- •Nonremovable metal orthodontic devices.
- •Oral health problems.
- •Chronic infectious diseases.
- •Sensitivity to nickel, gold or copper.
结局指标
主要结局
Primary safety endpoints
时间窗: 12 week
treatment - related serious adverse events (SAE) over 12 week treatment
次要结局
未报告次要终点