A Therapeutic Experience Program (TEP) Study Assessing Adherence to On-Label PoNS® Therapy for Improvement of Gait in People with Multiple Sclerosis (MS) in a Real-World Clinical Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 5
- 主要终点
- Measure subjects' adherence to PoNS therapy (device + physical therapy)
研究概览
简要总结
PoNS therapy is a rehabilitation program that uses the PoNS device in conjunction with individualized physical exercise. This is an outcome research open label observational interventional multi-center study investigating the relationship between subject's adherence to PoNS therapy and therapeutic outcomes.
详细描述
Study participants will undergo fourteen weeks of on-label PoNS therapy and, specifically, two weeks in-clinic PoNS therapy directly supervised by a physical therapist who has been trained on PoNS therapy by Helius Medical and certified as a clinic PoNS trainer (Phase 1) followed by 12 weeks of at-home unsupervised PoNS therapy Once weekly in-clinic PoNS therapy session (Phase 2). Subjects will be then asked to return to the clinic six month after the end of the study Phase 2 to assess maintenance of PoNS therapy effects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ≥ 22 years of age with a diagnosis of MS.
- •EDSS scores < 6.5 at screening; a demonstrated gait deficit.
- •Can walk at least 10 meters with or without the use of walking aids.
- •Participants must be stable without relapse for at least 60 days and agree to PoNS therapy regimen.
排除标准
- •Other neurological, visual, or orthopedic problems that significantly interfere with balance or gait.
- •Subjects who are currently attending physical rehabilitation and are unwilling to switch to PoNS-specific physical therapy regimen.
- •Subjects who are already functional community ambulators (gait speed>120cm/s43).
- •Subjects will also be excluded as per the Helius Medical PoNS device indication for usage ("electrical stimulation should not be used: if there is an active or suspected malignant tumor; in areas of recent bleeding or open wounds; in areas that lack normal sensation; in women who are pregnant, or in people with sensitivity to nickel, gold or copper").
结局指标
主要结局
Measure subjects' adherence to PoNS therapy (device + physical therapy)
时间窗: 14 weeks
Subjects' adherence to at-home PoNS therapy (device + physical therapy) over 12 weeks following 2 weeks of supervised PoNS therapy at a physical therapy clinic and the relationship between subject's therapy adherence behavior and therapeutic functional outcomes as measured by the Dynamic Gait Index (DGI).
次要结局
- 3) Association between likelihood of second course of therapy and magnitudes of improvement with adherence during the initial therapy(14 weeks)
- 1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating(14 weeks)
- Clinical improvement among subjects receiving a second course of PoNS therapy as measured by:(14 weeks)