Gait Analysis in Patients Undergoing Rehabilitation Due to Lower Extremity Disability or Chronic Pain, Using OneStep Smartphone Application.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Walking Distance (General Gait Parameter)
研究概览
简要总结
OneStep technology is a smartphone application, utilizing smartphone sensors to provide ongoing gait diagnostics. In this longitudinal study, 50 consecutive patients with lower-extremity disability or chronic pain, will be using the One-Step App, downloaded to their personal smartphones, in parallel with the usual rehabilitation treatments, during a one-month period. Analyzed gait data from the App will be linked with clinical data collected by a team of experts, in order to evaluate the potential use of this App as an objective means to characterize and quantify patients' gait characteristics along the follow-up period, and to objectively assess the patients' adherence and compliance with the rehabilitation regime.
详细描述
Background:
Patient adherence is a crucial determinant of the rehabilitation process. After injury or surgery, many patients are given specific exercises to conduct unsupervised on their own to aid their recovery. Evidence suggests that noncompliance with the prescribed exercise regime is associated with poor rehabilitation outcomes. OneStep technology is a smartphone application (App), which uses smartphone sensors to provide ongoing gait diagnostics.
Study Objectives:
- To analyze gait-related parameters collected via the OneStep App in patients with lower extremity disability or chronic pain over a 4-week follow-up period during in-hospital physiotherapy sessions, self-exercises at home, and other daily activities,
- To objectively assess the patients' adherence and compliance with the prescribed rehabilitation regime. For the purposes of this research, adherence refers to the quantity and frequency of completed home exercises, while compliance refers to the quality of meeting the physiotherapists' walking-related recommendations.
- To assess gait parameters measured simultaneously on both feet, during standard walking-related tests, (performed under similar conditions on days 1, 14, 28, while using the OneStep App), for between and within-subject comparison.
- To compare between patients' subjective self-reports on performed physiotherapy workouts at home, the physiotherapists' own subjective assessments on their patients' adherence and compliance, and the objective data collected using the OneStep App
Methods:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 to 65 years old.
- •Able to walk independently or with assistance (human/walking aids).
- •Able to speak and read fluently in Hebrew.
- •Admitted for rehabilitation at a rehabilitation hospital day-care center following lower-extremity disability or chronic pain (unilateral or bilateral).
- •Have undergone at least 4 weeks of rehabilitation, but require an additional (at least one month long) rehabilitation course.
- •Subjects must be willing to use their own smartphone device to install the OneStep application for study procedures and to comply with the study protocol.
- •The subjects' smartphone has to be compatible with the OneStep app hardware requirements.
排除标准
- •Subject unable to step on the sore foot.
- •Subject unfit to participate in the study based on the judgment of the study principal investigator.
- •Subjects who are permanently wheelchair-bound.
- •Subjects with known pregnancy.
结局指标
主要结局
Walking Distance (General Gait Parameter)
时间窗: One month of follow-up
The daily walking distance (in meters) as measured by the OneStep App
Walking Time (General Gait Parameter)
时间窗: One month of follow-up
The daily walking time (in minutes) as measured by the OneStep App
Step Count (General Gait Parameter)
时间窗: One month of follow-up
The daily step count (number of steps) as measured by the OneStep App
Step Time (Leg Specific Parameter)
时间窗: One month of follow-up
The average daily step time (in seconds) as measured by the OneStep App
Motion of the Hip Joint (Leg Specific Parameter)
时间窗: One month of follow-up
The daily range of hip joint motion (in degrees) as measured by the OneStep App while walking.
Patients' Adherence with the Rehabilitation Regime
时间窗: One month of follow-up
The patients' adherence with the rehabilitation regime refers to the quantity and frequency of completed home exercises, converted into an adherence score. Patients' self-reports and physiotherapists' own assessments on patients' adherence will be collected using newly developed questionnaires, while the objective data on patients' adherence will be collected using the OneStep App.
Patients' Compliance with the Rehabilitation Regime
时间窗: One month of follow-up
The patients' compliance with the rehabilitation regime refers to the quality of meeting the physiotherapists' walking-related recommendations, converted into a Compliance score. Patients' self-reports and physiotherapists' own assessments on patients' compliance will be collected using newly developed questionnaires, while the objective data on patients' compliance will be collected using the OneStep App.
次要结局
- 6-Minute Walk Test (6MWT)(Assessed at days 1, 14 and 28 of the follow-up period)
- Timed Up and Go (TUG) Test(Assessed at days 1, 14 and 28 of the follow-up period)
- 10-Meter Walk Test (10MWT)(Assessed at days 1, 14 and 28 of the follow-up period)
研究者
Dana Gefen Doron
Principal Investigator
Reuth Rehabilitation Hospital