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Clinical Trials/NCT07434570
NCT07434570
Completed
Not Applicable

Evaluating the Effectiveness of Video-based Apps in Healthcare

University of Calgary1 site in 1 country15 target enrollmentStarted: December 12, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
15
Locations
1
Primary Endpoint
Activities-specific Balance Confidence (ABC) Scale

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
6 Years to 99 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Between the ages of 6 and 99
  • Currently using a walker, crutch(es), or cane(s) ≥ 5 days/week, OR will be expecting to use such a walking aid for ≥ 7 days in a row (for those undergoing planned surgery)

Exclusion Criteria

  • Self-identify as being unable to comfortably communicate in English
  • Self-identify as having a significant visual impairment that would affect their ability to use an app that involves watching videos
  • Self-identify as using a wheelchair, walking poles, or a knee scooter for ≥ 75% of the time for mobility

Arms & Interventions

Intervention Group

Experimental

Participants will use a video feedback-based app to learn how to correctly fit and walk with their usual gait aid.

Intervention: Walking Aid Skills App (Device)

Control Group

Sham Comparator

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.

Intervention: Attentional Control (Device)

Outcomes

Primary Outcomes

Activities-specific Balance Confidence (ABC) Scale

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.

Secondary Outcomes

  • Objective knowledge: Multiple-choice knowledge test(At all 3 data collection sessions. (T1: Baseline; T2: Baseline + 4-6 days, T3: Baseline + 26-30 days))
  • Self-reported confidence in 4 skill domains (walking aid fitting, assisted gait with a walking aid, deep breathing for stress relief, and safely turning in bed)(At all 3 data collections sessions. (T1: Baseline; T2: Baseline + 4-6 days, T3: Baseline + 26-30 days))
  • Self-reported knowledge in 4 skill domains (walking aid fitting, assisted gait with a walking aid, deep breathing for stress relief, and safely turning in bed)(At all 3 data collections sessions. (T1: Baseline; T2: Baseline + 4-6 days, T3: Baseline + 26-30 days))
  • Self-reported comfort with 4 skill domains (walking aid fitting, assisted gait with a walking aid, deep breathing for stress relief, and safely turning in bed)(At all 3 data collections sessions. (T1: Baseline; T2: Baseline + 4-6 days, T3: Baseline + 26-30 days))
  • Upper limb pain: Numerical Pain Rating Scale (NPRS)(At all data collection sessions. (T1: Baseline; T2: Baseline + 4-6 days; T3: Baseline + 26-30 days))
  • Lower limb pain: Numerical Pain Rating Scale (NPRS)(At all data collection sessions. (T1: Baseline; T2: Baseline + 4-6 days; T3: Baseline + 26-30 days))
  • Description of Skin Issues(At all 3 data collection periods. (T1: Baseline, T2: Baseline + 4-6 days, T3: Baseline + 26-30 days))
  • Number of Falls(At all 3 data collection periods. (T1: Baseline, T2: Baseline + 4-6 days, T3: Baseline + 26-30 days))
  • System Usability Scale (SUS)(During data collection periods involving app use (T1: Baseline; T2: T1 + 4-6 days).)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ranita Manocha

Clinical Associate Professor

University of Calgary

Study Sites (1)

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