Description

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.

There have been no published studies on the minimal clinically important difference of the ABC. A previous study on 376 knee osteoarthritis patients resulted in an increase in ABC scores by a mean of 9.15 at 1-year post-total knee arthroplasty. Using a repeated-measures Cohen's d, the effect size in that study was 0.585. As such, a sample size of 18 would be sufficient to explore two-tailed differences within a single individual over time on the ABC as they were recovering from their injury (1-β=0.8, α=0.05; G*Power, Germany). However, we would like to explore the differences between two groups (app exposures) as a primary outcome. We also wish to explore sex-based differences and want to incorporate a conservative estimate 10% dropout rate. As such, it is likely that 26 participants in each cohort will be sufficient to find significant differences for the primary outcome variable being investigated.

Participants will be randomly assigned to the experimental or control groups using 1:1 allocation ratio to increase the power to detect statistically significant differences between groups. To support balance between groups, a computerized randomization process, stratified by site (4 sites) and sex with block sizes of 2, 4, and 6, designed by a biostatician using SPSS3 (IBM, Armonk, USA) will be used.

Information on the baseline covariates will be presented for the two groups. Rates of non-participation will be reported. All primary and exploratory secondary mobility outcome measures will be assessed for normality using the Shapiro-Wilk test in SPSS (IBM, Armonk, USA). ABC scores will be analyzed using a two-way repeated measures analysis of variance with Greenhouse-Geisser correction with time and app group as factors. For the remaining variables, between-group differences will be investigated using either independent group t-tests or non-parametric Mann-Whitney U tests in SPSS. α = 0.05 will be used for all testing, with correction for multiple comparisons using the Benjamini-Hochberg approach.

Primary outcome variables will be analyzed in SPSS. Reliability will be analyzed in Microsoft Excel and will be investigated using independent and dependent group t-tests in Excel, with a p-value set at <0.05. Validity will be analyzed in Microsoft Excel and compared to predicted ability to walk, and the Walking Aid Skills Test scores compared to the Timed-Up and Go, Balance Scale and 2-minute Walk. Reliability will be analyzed in Microsoft Excel and compared scores of the same reviewer over time and between reviewers.