Treatment of Hemiparetic Gait Impairments Using Telehealth With the Moterum iStride Solution™
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Feasibility of safely implementing the treatment protocol
研究概览
简要总结
The objective of this research is to investigate the feasibility of delivering gait treatment using the Moterum iStride Solution™ to individuals with hemiparetic gait impairments using a telemedicine modality, the Moterum Digital Platform.
详细描述
Hemiparesis, a common disabling consequence of stroke and other neurologic conditions, can lead to abnormal gait function often characterized by asymmetric patterns and decreased gait speed. A large percentage of stroke survivors, up to 70%, experience gait dysfunction, which can lead to reduced activity levels, limited community participation, and contribute to an increased risk of falls. Effective interventions to treat gait dysfunction are essential to reduce disability for these individuals.
The iStride™ gait device, initially designed to mimic the symmetry-improving mechanism of a split-belt treadmill, was developed to treat asymmetric gait impairments in stroke survivors. Unlike many currently available gait treatment devices, the iStride™ device is portable, therefore allowing gait treatment to occur overground and from the home environment. Training in natural environments is believed to enhance the transfer of learning as well as enable long-term training. Previously published studies with the iStride™ device demonstrate its ability to beneficially improve functional gait parameters, gait speed, and reduce fall risk in both clinical and home settings.
To monitor improvement in gait function, the device is paired with patented iStride sensors™. The combined system, the Moterum iStride Solution™, is currently being used by stroke survivors in the home environment. In the current delivery model, users are provided instruction and training from physical therapists in clinical settings before using the device in their home environment under the supervision of a Moterum staff member. User feedback has led to the exploration of novel methods to deliver device treatment remotely. [Additionally, the need for remote treatment has increased in urgency with the onset of the coronavirus pandemic and social distancing guidelines.]
In this study, treatment with the iStride™ will be adapted to remote delivery using a telemedicine platform, the Moterum Digital Platform. A screening process will be implemented to guide participant selection and identify individuals likely to be successful with remote treatment delivery using the telemedicine modality. This process consists of an initial eligibility criteria review followed by a physical therapist video review of participant walking patterns.
Once enrolled in the clinical trial, participants will receive study-related equipment including the iStride™ device, Moterum iStride Hub and Sensors™, and a pre-measured strap for gait testing. They will be instructed in the download of the Moterum Digital Platform which will serve as the telemedicine modality for subsequent communication. Participants and their caregivers will be provided with instructional videos as well as therapist training on study procedures using video calls through the telemedicine platform. Instruction will include telemedicine portal navigation, iStride™ fitting (donning/doffing), mobility and walking guidelines with iStride™ device, assessment performance, environmental considerations, safety precautions, and caregiver guidelines and responsibilities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21-80
- •Caregiver support. The caregiver should be an adult over the age of 18 without physical or cognitive limitations which would prohibit them from being able to provide appropriate assistance to the device user
- •Hemiparesis
- •If hemiparesis is due to a stroke, the stroke occurred at least 3 months prior to enrollment
- •Gait asymmetry
- •Able to walk independently with or without a cane or hemiwalker, (Modified Rankin Score 3 or less)
- •No evidence of severe cognitive impairment that would interfere with understanding the instructions
- •At least 25 feet of walking space (does not need to be a straight line)
- •Weight does not exceed 275lbs
排除标准
- •Uncontrolled seizures
- •Metal implants (stents, clips, pacemaker)
- •Pregnancy
- •Chronic Obstructive Pulmonary Disease
- •Uncontrolled blood pressure
- •Myocardial infarction within the last 180 days
- •Cannot rely on a rolling walker for ambulation
- •Severe ataxia interfering with safety on the device
- •Previously diagnosed vestibular ear issues interfering with safety on the device
结局指标
主要结局
Feasibility of safely implementing the treatment protocol
时间窗: Determined at the end of the 12-session treatment period (approximately 4 weeks after beginning the treatment).
The described delivery method includes using remote physical therapist treatment oversight and physical supervision of treatment activities by trained caregivers. Due to the inclusion criteria, patients already have some risk of falls and need for assistance while walking. The caregivers will record assistance levels provided during treatment. Any adverse events will be immediately reported and reviewed. The remote physical therapists will regularly review assistance levels to ensure the participant is requiring an appropriate level of assistance. The feasibility of safely delivering treatment will be assessed by two measures: (a) the daily safety rate, defined as the percentage of days an adverse event occurred out of the total number of treatment days, and (2) assistance required and adverse events experienced for each participant, compared to the group, and compared to our prior research.
Achievability of telemedicine delivery protocol
时间窗: Determined within one week after the final follow-up assessment (12-month follow-up) is completed. The 12-month follow-up assessment will occur 12-months after completion of the 4-week treatment period.
The achievability of this treatment delivery method will be assessed by measuring participant compliance to the protocol tasks. These tasks include scheduled treatment sessions, functional and psychosocial outcome measures, and sensor-based activities. Achievability will be defined as the percentage of completed protocol activities out of the total scheduled activities.
次要结局
- Stakeholder Acceptability(Determined within one week after the final follow-up assessment (12-month follow-up) is completed. The 12-month follow-up assessment will occur 12-months after completion of the 4-week treatment period.)
- Feasibility of screening criteria(Determined at the end of the 12-session treatment period (approximately 4 weeks after beginning the treatment).)