Exploring the Influence of a Novel Application for Training and Evaluating Walking Implementation of an App-based Walking Aid Skills Training Program Aid Skills in Walking Aid Users: A Protocol for a Pragmatic Single-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Activities-specific Balance Confidence (ABC)
研究概览
简要总结
Walking aids (WA), such as crutches, canes, and walkers allow individuals to move independently after lower body impairment. Improper WA use may lead to upper body discomfort, pain, or injury. Improper WA use has been associated with increased risk of falls, which may result in traumatic brain injury or even death. WA-related accidents and injuries may not only affect an individual patient's quality of life; they may also increase healthcare system resource use and caregiver burden. WA-related injuries may be preventable if WA are properly fit and sufficient training is provided to the WA user.
Smartphone applications (apps) are widely used technologies that have been used to improve health outcomes in populations of healthy and chronically ill individuals. We have developed an app that can be used to teach WA users how to properly fit and use their devices. This app is called Improving Canadians' Walking Aid skills, Learning, and Knowledge (ICanWALK©).
The development of the Walking Aids Skills Test© (WAST©) allows for the objective measurement of how well an individual uses their walking aid. It is important to develop such a measurement in order to see whether interventions such as mobile applications change a walking aid user's ability to walk with their device. This 12-item objective evaluation measures the ability of an individual to use their walking aid in different settings, while picking up an object off the ground, navigating stairs, or encountering terrains such as gravel or grass.
Three hypotheses will be explored through this clinical trial. Hypothesis 1: Patients who use the ICanWALK© app will have improved balance confidence compared to the control group.
Hypothesis 2: Patients who use the ICanWALK© app will have improved balance, improved mobility, less pain, and fewer falls compared to the control group.
Hypothesis 3: The WAST© will have an inter-rater reliability of 70% (k=0.85).
详细描述
This study is a single-masked 2-centre randomized control trial. In order to evaluate the usability and feasibility of the app, we will evaluate 52 (26 female) patients and their physical therapists. Participants will be randomly assigned to either the experimental or control group, both of which will use apps available from Move Improve®. Through the Move Improve® platform, both groups will be shown instructional videos of different movement skills, and then will be able to record secure videos of themselves performing the skills. The control group will watch videos related to breathing skills and the treatment group will watch videos related to walking aids. Patients must be aged 18-80 years and require the regular (>75% of ambulatory time) use of a WA. Patients will be recruited from the South Health Campus Neuromuscular and Orthopedic Clinics, Foothills Medical Centre Orthopedic Surgery and Physiatry Clinics, Foothills Medical Centre Orthopedic Inpatients Units, Foothills Medical Centre Day Surgery Units, University of Calgary Sports Medicine Centre, Momentum Health Physiotherapy Clinics (all in Calgary, Alberta), and Centre interdisciplinaire de recherche en réadaptation et intégration sociale (CIRRIS, in Québec City, Québec) where they will be informed of the project during clinical sessions with their practitioners. Potential patient participants will be screened in-person by a Research Assistant to determine their eligibility.
The primary outcome of the study is the Activities-specific Balance Confidence (ABC) scale assessed at baseline and 4 weeks. Secondary outcomes include the following at baseline and 4 weeks: Timed Up and Go (TUG), 6-Minute Walk Test (6MWT), Berg Balance Score (BBS), Walking Aid Skills Test© (WAST©), number of falls, and a description of upper limb location and pain. Additionally, we will consider both the patient and clinician participant's perspectives about the perceived usefulness, ease of use of, and satisfaction with the app and will ask them about perceived treatment effect and additional time required during therapy sessions. Participant's time spent on and score of each component will also be recorded.
Eligible participants will sign consent forms to participate. During their usual physical therapy session, the patient will use the app on 2 occasions (up to 15 minutes). After the session, the patient will each be asked to complete online questionnaires via Qualtrics (Utah, USA) on the iPad. The questionnaires will include confidence using walking aid, comfort using walking aid, Activity-specific Balance Confidence (ABC) Scale, app ease of use, app usability, and app satisfaction. The Research Assistant will be available during the session in case problems arise.
A physical assessment will occur at baseline, 2-weeks, and 4-weeks after initial assessment. The physical assessment contains the BBS, 6MWT, and WAST©. This evaluation will be conducted by the Research Assistant.
The WAST© will be video recorded by the Research Assistant. We will ask physical therapists to rate the videos of the participants to determine the reliability and validity of the walking aid skills test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient at a study site currently using walking aids >75% of their ambulatory time
- •age 18-99
排除标准
- •currently using a wheelchair >25% of their ambulatory time
- •cannot comfortably communicate in English or French
- •history of significant cognitive or visual impairment that would affect their ability to use the app interventions
- •unable to give voluntary informed consent
研究组 & 干预措施
Control Group
Breathing Skills App
干预措施: Breathing skills app (Other)
Experimental Group
ICanWALK© App
干预措施: Walking aid skills app (Other)
结局指标
主要结局
Activities-specific Balance Confidence (ABC)
时间窗: baseline, 2 weeks, 4 weeks
16-item self-report measure that asks individuals to rate their balance confidence in performing a range of activities from 0% to 100%.
次要结局
- 2-minute walk test(baseline, 2 weeks, 4 weeks)
- Timed Up and Go(baseline, 2 weeks, 4 weeks)
- Berg Balance Scale(baseline, 2 weeks, 4 weeks)
- Walking Aid Skills Test©(baseline, 2 weeks and 4 weeks)
研究者
Ranita Manocha
Principal Investigator
University of Calgary
