NCT05347875

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jun 2024Jun 2026

First Submitted

Initial submission to the registry

April 14, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
2.1 years until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

April 14, 2022

Last Update Submit

March 5, 2026

Conditions

Keywords

Gait aidWalking aidCaneCrutchWalker

Outcome Measures

Primary Outcomes (1)

  • Activities-specific Balance Confidence (ABC)

    16-item self-report measure that asks individuals to rate their balance confidence in performing a range of activities from 0% to 100%.

    baseline, 2 weeks, 4 weeks

Secondary Outcomes (4)

  • 2-minute walk test

    baseline, 2 weeks, 4 weeks

  • Berg Balance Scale

    baseline, 2 weeks, 4 weeks

  • Timed Up and Go

    baseline, 2 weeks, 4 weeks

  • Walking Aid Skills Test©

    baseline, 2 weeks and 4 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Breathing Skills App

Other: Breathing skills app

Experimental Group

EXPERIMENTAL

ICanWALK© App

Other: Walking aid skills app

Interventions

The interventional app teaches users how to fit, walk with, and navigate stairs and chairs with a walking aid. It contains instructional videos with key "components" of these skills highlighted. The user can use their phone's video to record themselves performing the taught skills to enable them to review their usage of the walking aids.

Also known as: ICanWALK
Experimental Group

This app has the same interface as the ICanWALK app. Instead, it teaches deep breathing for stress relief and breathing to improve lung function.

Control Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient at a study site currently using walking aids \>75% of their ambulatory time
  • age 18-99

You may not qualify if:

  • currently using a wheelchair \>25% of their ambulatory time
  • cannot comfortably communicate in English or French
  • history of significant cognitive or visual impairment that would affect their ability to use the app interventions
  • unable to give voluntary informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Foothills Medical Centre

Calgary, Alberta, Canada

RECRUITING

CIRRIS

Québec, Quebec, Canada

COMPLETED

Related Publications (2)

  • 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.

    PMID: 29185496BACKGROUND
  • Nindorera F, Manocha RHK, Miller WC, Routhier F, Best KL. Exploring the Influence of a Novel App for Training and Evaluating Walking Aid Skills in Walking Aid Users: Protocol for a Pragmatic Single-Blind Randomized Controlled Trial. JMIR Res Protoc. 2025 Dec 24;14:e71060. doi: 10.2196/71060.

MeSH Terms

Conditions

Sprains and StrainsStrokeMultiple Sclerosis

Condition Hierarchy (Ancestors)

Wounds and InjuriesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ranita Manocha, MD, MSc

    University of Calgary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ranita Manocha, MD, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 14, 2022

First Posted

April 26, 2022

Study Start

June 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Anonymized IPD will be shared if requested on a case-by-case basis.

Locations