- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07434570
Evaluating the Effectiveness of Video-based Apps in Healthcare
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:
- Does this app improve balance confidence in walking aid users, as compared to a sham app?
- 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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 4N1
- University of Calgary Foothills
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Participants will use a video feedback-based app to learn how to correctly fit and walk with their usual gait aid.
|
Participants will use a video feedback-based app to learn how to correctly fit and walk with their usual gait aid.
|
|
Sham Comparator: Control Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Will be obtained during data collection for all 3 timepoints (T1: baseline, T2: T1 + 4-6 days, T3: T1 + 26-30 days).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
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.
|
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)
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.
|
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)
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.
|
At all 3 data collections sessions. (T1: Baseline; T2: Baseline + 4-6 days, T3: Baseline + 26-30 days)
|
|
Objective knowledge: Multiple-choice knowledge test
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.
|
At all 3 data collection sessions. (T1: Baseline; T2: Baseline + 4-6 days, T3: Baseline + 26-30 days)
|
|
Upper limb pain: Numerical Pain Rating Scale (NPRS)
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.
|
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)
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.
|
At all data collection sessions. (T1: Baseline; T2: Baseline + 4-6 days; T3: Baseline + 26-30 days)
|
|
Description of Skin Issues
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.
|
At all 3 data collection periods. (T1: Baseline, T2: Baseline + 4-6 days, T3: Baseline + 26-30 days)
|
|
Number of Falls
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.]
|
At all 3 data collection periods. (T1: Baseline, T2: Baseline + 4-6 days, T3: Baseline + 26-30 days)
|
|
System Usability Scale (SUS)
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).
|
During data collection periods involving app use (T1: Baseline; T2: T1 + 4-6 days).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- REB24-1450
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mobility Impairments
-
University of MichiganTerminated
-
University of Alabama at BirminghamRecruitingMobility ImpairmentsUnited States
-
IRCCS Eugenio MedeaPolitecnico di MilanoRecruitingNeuromotor ImpairmentsItaly
-
Shanghai Jiao Tong University School of MedicineCompletedNeurological ImpairmentsChina
-
University of MontanaNational Institute of General Medical Sciences (NIGMS)RecruitingNeuromotor ImpairmentsUnited States
-
IRCCS Fondazione Stella MarisIRCCS Eugenio Medea; Fondazione Don Carlo Gnocchi Onlus; Istituto Giannina Gaslini and other collaboratorsRecruiting
-
University of AlbertaRecruitingChildren With Motor ImpairmentsCanada
-
University of CalgaryRecruitingWalking Impairment | Neuromotor ImpairmentsCanada
-
Hadassah Medical OrganizationUnknownMotor Impairments | Orthopaedic Injuries | Neurological ConditionsIsrael
-
First Affiliated Hospital, Sun Yat-Sen UniversityNot yet recruitingSubclinical Cardiovascular Impairments | Cardiovascular (CV) Risk | MASLDChina
Clinical Trials on Walking Aid Skills App
-
University of CalgaryAlberta Health services; Laval University; Centre interdisciplinaire de recherche...RecruitingStroke | Multiple Sclerosis | Lower Limb Fracture | Lower Limb; Sprain (Strain)Canada
-
Trakya UniversityCompletedPain | Coronary Artery Bypass Graft Surgery | Walking, Difficulty | Early MobilizationTurkey
-
Klein Buendel, Inc.National Institute on Minority Health and Health Disparities (NIMHD); Stanford...CompletedPhysical ActivityUnited States
-
University of ValenciaCompletedCoronavirus Infection | Respiratory DiseaseSpain
-
Tel-Aviv Sourasky Medical CenterRecruiting
-
Hospital Sirio-LibanesCompletedMobility LimitationBrazil
-
Medical University of ViennaActive, not recruiting
-
Pennington Biomedical Research CenterEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedPhysical Activity | Development, Child | Self-regulation | Fundamental Motor SkillsUnited States
-
Massachusetts General HospitalPatient-Centered Outcomes Research Institute; University of Colorado, Denver; University of Pennsylvania and other collaboratorsEnrolling by invitationAortic StenosisUnited States
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedIntimate Partner ViolenceUnited States