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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
153

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 28, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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