Walking Aid and Locomotion Knowledge in Emergency Rooms (WALKER 1) for Elderly People (WALKER 1)

April 22, 2025 updated by: Hospital Sirio-Libanes

Walking Aid and Locomotion Knowledge in Emergency Rooms (WALKER 1): Training and Provision of Walking Aids to Promote Autonomy and Mobility of Elderly People in Emergency Care - a Randomized Clinical Trial

Older adults have higher rates of emergency department admissions when compared to their younger counterparts. Mobility is the ability to move around but also encompasses the environment and the ability to adapt to it. Walking aids can be used to improve mobility and prevent falls. According to international guidelines, they must be available in Geriatric Emergency Department. This study aims to evaluate the effectiveness of a program of training and provision of walking aids (WA), associated or not with telemonitoring, on mobility, quality of life, fear of falling, and risk of falls up to 3 months in older adults cared for in an emergency department.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized clinical trial will be carried out in the emergency department of Hospital Sírio-Libanês. Participants will be randomized and allocated into three intervention groups, as follows: A) Walking aid group; B) Walking aid and telemonitoring group; C) Control group. Patients will undergo a baseline evaluation encompassing sociodemographic and clinical data, mobility in life spaces (Life Space Assessment), gait speed, muscle strength, functionality (Barthel Index, Katz index, and Lawton-Brody Scale), quality of life (Euro Quality of Life Instrument-5D), fear of falling (Falls Efficacy Scale International), history of falls, cognition (10-Point Cognitive Screener) and mood (15-point Geriatric Depression Scale) before the intervention. Gait time and fear of falling will be assessed again after the intervention. Finally, mobility in life spaces, functionality, quality of life, fear of falling, history of falls, cognition, and mood will be assessed 3 months after discharge from the geriatric emergency department through a telephone interview.

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 01308-050
        • Hospital Sírio Libanês

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 65 years or older
  • Admitted to the Geriatric Emergency Department of Hospital Sírio-Libanês
  • Willing and able to give informed consent
  • Least one of the following for indication and training of mobility aids: reduction of postural instability; improvement of motor control; increase of somatosensory feedback; reduction of biomechanical overload; safe promotion of autonomy; fall history (in the last six months).

Exclusion Criteria:

  • Altered level of conscience
  • need for supplemental oxygen (≥3L/min)
  • respiratory distress
  • hemodynamic instability
  • postural instability with a tendency to fall backward
  • cognitive impairment that limits the use of walking aids
  • hospitalization after Emergency Department evaluation
  • Delirium

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Walking aid (WA) group
Participants will receive the walking aid and training in the use of the device.
Device: Walking aid
A physiotherapist will identify the mobility needs and will indicate the most appropriate walking aid (cane or walker).
Other: Guidance on safe walking and risk of falling
Participants will receive verbal guidance and printed material with guidance on safe walking and fall prevention.
Experimental: Walking aid with telemonitoring (WAT) group
Participants will receive the walking aid and training in the use of the device associated with telemonitoring.
Device: Walking aid
A physiotherapist will identify the mobility needs and will indicate the most appropriate walking aid (cane or walker).
Other: Guidance on safe walking and risk of falling
Participants will receive verbal guidance and printed material with guidance on safe walking and fall prevention.
Other: Telemonitoring
Telemonitoring will occur every two weeks for three months after the emergency department discharge, through video call (about 15 minutes). On these opportunities, the importance of using mobile devices and the guidance on safe gait will be reinforced.
Other: Control group
Participants will receive verbal guidance and printed material.
Other: Guidance on safe walking and risk of falling
Participants will receive verbal guidance and printed material with guidance on safe walking and fall prevention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Life-Space Assessment (LSA)
Time Frame: At baseline and after completion of the 3 and 6 months intervention to assess change
LSA is a scale which allows the characterization of mobility in life-spaces specifically frequency, need for mobility aids and the help of third party in the last 4 weeks
At baseline and after completion of the 3 and 6 months intervention to assess change
Falls Efficacy Scale International (FES-I)
Time Frame: At baseline, immediately after the intervention and after completion of the 3 and 6 months intervention to assess change
Assesses fear of falling
At baseline, immediately after the intervention and after completion of the 3 and 6 months intervention to assess change

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go test (TUG)
Time Frame: At baseline and immediately after the intervention
TUG evaluate mobility, balance, gait, and risk of falling
At baseline and immediately after the intervention
One-minute sit-to-stand test
Time Frame: At baseline and after completion of the 3 and 6 months intervention to assess change
Functional capacity assessment by sit and stand completely in a chair (as often as possible during 1 minute)
At baseline and after completion of the 3 and 6 months intervention to assess change
Katz index
Time Frame: At baseline and after completion of the 3 and 6 months intervention to assess change
Katz index is a scale which evaluate basic activities of daily living
At baseline and after completion of the 3 and 6 months intervention to assess change
Barthel index
Time Frame: At baseline and after completion of the 3 and 6 months intervention to assess change
Barthel index is a scale which evaluates the autonomy for self-care, in addition to mobility
At baseline and after completion of the 3 and 6 months intervention to assess change
Lawton-Brody scale
Time Frame: At baseline and after completion of the 3 and 6 months intervention to assess change
Lawton-Brody scale evaluate Instrumental activities of daily living
At baseline and after completion of the 3 and 6 months intervention to assess change
Euro Quality of Life Instrument-5D (EQ-5D)
Time Frame: At baseline and after completion of the 3 and 6 months intervention to assess change
EQ-5D evaluate quality of life in five health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and self-rated health on a visual analog scale
At baseline and after completion of the 3 and 6 months intervention to assess change
Geriatric Depression Scale (GDS-15)
Time Frame: At baseline and after completion of the 3 and 6 months intervention to assess change
Assesses mood disorders
At baseline and after completion of the 3 and 6 months intervention to assess change
10-Point Cognitive Screener (10-CS)
Time Frame: At baseline and after completion of the 3 and 6 months intervention to assess change
10-CS consists of a brief cognitive screening which evaluate temporal orientation, verbal fluency and three-word recall
At baseline and after completion of the 3 and 6 months intervention to assess change
Fall History
Time Frame: At baseline and after completion of the 3 and 6 months intervention to assess change
Fall history evaluate occurrence of falls (including data location, associated injuries, need for special care after the fall) and the total number of falls
At baseline and after completion of the 3 and 6 months intervention to assess change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sirio-Libanes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2023

Primary Completion (Actual)

December 28, 2024

Study Completion (Actual)

December 28, 2024

Study Registration Dates

First Submitted

July 10, 2023

First Submitted That Met QC Criteria

July 10, 2023

First Posted (Actual)

July 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVAP-NG 2999

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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