University of Calgary Foothills
Calgary, Alberta, T2N 4N1, Canada
NCT Number: NCT07434570
The goal of this clinical trial is to understand the effectiveness of a novel video-feedback based mobile application that teaches walking aid skills to current or anticipated walking aid users. The main questions it aims to answer are:
1. Does this app improve balance confidence in walking aid users, as compared to a sham app? 2. Does this app improve clinically relevant outcomes in walking aid users, as compared to a sham app?
Researchers will compare balance confidence and clinical outcomes to a control group undergoing the same protocol but using an identical app that teaches teaching general health skills instead. The intervention group will be learning the skills of fitting and walking with their gait aid while the control group will be learning the skills of deep breathing to reduce stress and turning in bed safely.
Participants will take part in 3 data collection sessions. The first two, that will be about 4-6 days apart, are identical. During these two data sessions, the participants will begin by completing a pre-app survey, then completing 2 app modules, and finish by completing a post-app survey. About 26-30 days after the second study visit, participants will be asked to complete a survey.
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Notify Me6 year–99 year
All sexes
Interventional
Not applicable
Calgary, Alberta, T2N 4N1, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will use a video feedback-based app to learn how to correctly fit and walk with their usual gait aid.
Participants will use an attentional control app (same interface as the interventional app) to learn how to breathe deeply to reduce stress and how to turn in bed safely from back-to-side.
Time frame: Will be obtained during data collection for all 3 timepoints (T1: baseline, T2: T1 + 4-6 days, T3: T1 + 26-30 days).
The ABC is a 16-item self-reported questionnaire. Items involve tasks that may challenge balance. For each item, the individual rates their confidence in performing the task without losing their balance from 0% (not confident) to 100% (completely confident). The total score ranges from 0% (not confident) to 100% (completely confident). Higher scores mean a better outcome.
Time frame: At all 3 data collections sessions. (T1: Baseline; T2: Baseline + 4-6 days, T3: Baseline + 26-30 days)
Participants will rate their confidence in performing each skill using a 5-point Likert scale (5 - very confident, 4 - somewhat confident, 3 - neutral, 2 - somewhat not confident, 1 - not confident). Higher scores mean a better outcome.
Time frame: At all 3 data collections sessions. (T1: Baseline; T2: Baseline + 4-6 days, T3: Baseline + 26-30 days)
Each question will ask the participant to rate their knowledge of each skill using a 5-point Likert scale (5 - extremely knowledgeable, 4 - somewhat knowledgeable, 3 - neither knowledgeable nor unknowledgeable, 2 - somewhat lacking in knowledge, 1 - extremely lacking in knowledge). A higher score means a better outcome.
Time frame: At all 3 data collections sessions. (T1: Baseline; T2: Baseline + 4-6 days, T3: Baseline + 26-30 days)
Each question will ask the participant to rate their comfort with performing each skill using a 5-point Likert scale (5 - extremely comfortable, 4 - somewhat comfortable, 3 - neither comfortable nor uncomfortable, 2 - somewhat uncomfortable, 1 - extremely uncomfortable). A higher score means a better outcome.
Time frame: At all 3 data collection sessions. (T1: Baseline; T2: Baseline + 4-6 days, T3: Baseline + 26-30 days)
The participant will answer a series of 4 multiple-choice questions regarding how to safely fit their walking aid and how to safely turn in bed. There is only one correct answer for each question.
Time frame: At all data collection sessions. (T1: Baseline; T2: Baseline + 4-6 days; T3: Baseline + 26-30 days)
The participant will report their average upper limb pain intensity over the past 7 days on a scale from 0 (no pain) to 10 (worst pain imaginable). A lower score means a better outcome.
Time frame: At all data collection sessions. (T1: Baseline; T2: Baseline + 4-6 days; T3: Baseline + 26-30 days)
The participant will rate their average lower limb pain intensity over the past 7 days on a scale of 0 (no pain) to 10 (worst pain imaginable). A lower score means a better outcome.
Time frame: At all 3 data collection periods. (T1: Baseline, T2: Baseline + 4-6 days, T3: Baseline + 26-30 days)
The participant will provide a qualitative description of any skin issues they have experienced within the past 7 days using an empty text box. The researcher will review the qualitative information to determine whether the issue could be a potential complication from using a walking aid based on the description and location of the skin problem reported.
Time frame: At all 3 data collection periods. (T1: Baseline, T2: Baseline + 4-6 days, T3: Baseline + 26-30 days)
The participant will report the number of falls they have experienced over the last 7 days. A fall will be defined for the participant as "an unexpected event in which the participant comes to rest on the ground, floor, or lower level" [as per Lamb SE, Jorstad-Stein EC, Hauer K, Becker C. Development of a Common Outcome Data Set for Fall Injury Prevention Trials: The Prevention of Falls Network Europe Consensus. J Am Geriatr Soc. 2005;53:1618-22.]
Time frame: During data collection periods involving app use (T1: Baseline; T2: T1 + 4-6 days).
The SUS is a 10-item questionnaire where users are asked to answer each usability item on the scale using a 5-item Likert Scale (5 - strongly agree, 4 - somewhat agree, 3 - neither agree nor disagree, 2 - somewhat disagree, 1 - strongly disagree). The total score ranges from 0 (lowest possible/worst usability) to 100 (highest possible/best usability).
University of Calgary
Other
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