Clinical trial NCT05347875: Implementation of an App-based Walking Aid Skills Training Program
Official title: Pragmatic Implementation of the Improving Canadians' Walking Aids Skills, Learning, and Knowledge (ICanWALK) App-based Walking Skills Training Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Limb; Sprain (Strain)
Lower Limb Fracture
Keywords: Gait aid
Walking aid
Cane
Crutch
Walker
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Health services
name: Canadian Academy of Sport & Exercise Medicine
First posted: 2022-04-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A four-site single-masked randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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 Measurement Test (WASMT ©) 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 while using crutches will have improved balance confidence compared to the control group. Hypothesis 2: Patients who use the ICanWALK© app while using crutches will have improved balance, improved mobility, less pain, and fewer falls compared to the control group. Hypothesis 3: The WASMT © will have an inter-rater reliability of 70% (k=0.85).

Detailed description: This study is a single-masked 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 Fundamental Movement Skillsand the treatment group will watch videos related to ICanWALK©. 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), Fowler Kennedy Sports Medicine Centre in London, Ontario, and Allan McGavin Sport Medicine Centre in Vancouver, B.C. where they will be informed of the project during clinical sessions with their practitioners. Potential patient participants will be screened in-person by the 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), 2-Minute Walk Test (2MWT), Berg Balance Score (BBS), Walking Aid Skills Measurement Test (WASMT), 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 and 4-weeks after initial assessment. The physical assessment contains a Berg Balance test, a 2-minute walk test, a Timed-Up and Go (TUG) Test and a Walking Aid Skills Measurement Test. This evaluation will be conducted by the Research Assistant.

At the end of all testing, clinician participants will be invited to participate in an in-person focus group using semi-structured questions. All focus group participants will be asked to maintain social distancing and wear medical-grade masks during the focus groups, following Alberta Health Services Covid-19 guidelines. This is more feasible than conducting online focus groups as the clinicians are physically located in the area of the research and are also used to following the Covid-19 protocols. Interviews will be audio-recorded, and audio recordings will be stored on a secure Alberta Health Services drive.

The Walking Aid Skills Test 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. Stratification will occur by site as usual clinical care, including teaching on crutch fitting and training, likely varies between regions.

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). Baseline versus 4-week 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 Microsoft Excel. Baseline and 4-week outcomes will be investigated using dependent group t-tests in Excel, with a p-value set at \< 0.05. Interviews will be transcribed verbatim and analyzed in Microsoft Excel. Open-ended questions will be analyzed in Microsoft Excel. Key themes from interviews and questions will be determined and coded. Key themes will be extracted from open-ended data and a comparison of codes will be used. A thematic map will be created where the final set of themes are defined. Focus groups and individual interviews will be recorded using a recorder and transcribed verbatim. Data coding and extraction will be performed using NVivo once a list of key themes is generated. A thematic map will be created where the final set of themes are defined. 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.

Eligibility criteria: Inclusion Criteria:

* patient at a study site with a lower limb injury or surgery currently using crutches \>75% of their ambulatory time

Exclusion Criteria:

* currently using a wheelchair \>25% of their ambulatory time; cannot comfortably communicate in English or French; history of significant cognitive, visual, or upper limb impairment

Primary outcomes:
measure: Activities-specific Balance Confidence (ABC)
timeFrame: 3 months
Secondary outcomes:
measure: 2-minute walk test
timeFrame: 13-17 days after pre-survey is delivered
measure: Berg Balance Scale
timeFrame: 13-17 days after pre-survey is delivered
measure: Timed Up and Go
timeFrame: 13-17 days after pre-survey is delivered
measure: Walking Aid Skills Measurement Test
timeFrame: 13-17 days after pre-survey is delivered
Other outcomes:
Locations:
Study officials:
affiliation: University of Calgary
name: Ranita Manocha, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Si HB, Zeng Y, Zhong J, Zhou ZK, Lu YR, Cheng JQ, Ning N, Shen B. The effect of primary total knee arthroplasty on the incidence of falls and balance-related functions in patients with osteoarthritis. Sci Rep. 2017 Nov 29;7(1):16583. doi: 10.1038/s41598-017-16867-4.