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

NCT ID: NCT05950269

Last Updated: 2025-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2024-12-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mobility Limitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
This study will be blind for the researchers involved in the post-telemonitoring assessments. Also, the data will be analyzed by a researcher who is not involved in the interventions or the assessments.

Study Groups

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Walking aid (WA) group

Participants will receive the walking aid and training in the use of the device.

Group Type EXPERIMENTAL

Walking aid

Intervention Type DEVICE

A physiotherapist will identify the mobility needs and will indicate the most appropriate walking aid (cane or walker).

Guidance on safe walking and risk of falling

Intervention Type OTHER

Participants will receive verbal guidance and printed material with guidance on safe walking and fall prevention.

Walking aid with telemonitoring (WAT) group

Participants will receive the walking aid and training in the use of the device associated with telemonitoring.

Group Type EXPERIMENTAL

Walking aid

Intervention Type DEVICE

A physiotherapist will identify the mobility needs and will indicate the most appropriate walking aid (cane or walker).

Telemonitoring

Intervention Type OTHER

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.

Guidance on safe walking and risk of falling

Intervention Type OTHER

Participants will receive verbal guidance and printed material with guidance on safe walking and fall prevention.

Control group

Participants will receive verbal guidance and printed material.

Group Type OTHER

Guidance on safe walking and risk of falling

Intervention Type OTHER

Participants will receive verbal guidance and printed material with guidance on safe walking and fall prevention.

Interventions

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Walking aid

A physiotherapist will identify the mobility needs and will indicate the most appropriate walking aid (cane or walker).

Intervention Type DEVICE

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Sirio-Libanes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Sírio Libanês

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Kennedy RE, Williams CP, Sawyer P, Lo AX, Connelly K, Nassel A, Brown CJ. Life-Space Predicts Health Care Utilization in Community-Dwelling Older Adults. J Aging Health. 2019 Feb;31(2):280-292. doi: 10.1177/0898264317730487. Epub 2017 Sep 14.

Reference Type BACKGROUND
PMID: 29254407 (View on PubMed)

Shimada H, Sawyer P, Harada K, Kaneya S, Nihei K, Asakawa Y, Yoshii C, Hagiwara A, Furuna T, Ishizaki T. Predictive validity of the classification schema for functional mobility tests in instrumental activities of daily living decline among older adults. Arch Phys Med Rehabil. 2010 Feb;91(2):241-6. doi: 10.1016/j.apmr.2009.10.027.

Reference Type BACKGROUND
PMID: 20159128 (View on PubMed)

Brown CJ, Kennedy RE, Lo AX, Williams CP, Sawyer P. Impact of Emergency Department Visits and Hospitalization on Mobility Among Community-Dwelling Older Adults. Am J Med. 2016 Oct;129(10):1124.e9-1124.e15. doi: 10.1016/j.amjmed.2016.05.016. Epub 2016 Jun 8.

Reference Type BACKGROUND
PMID: 27288857 (View on PubMed)

van den Berg N, Schumann M, Kraft K, Hoffmann W. Telemedicine and telecare for older patients--a systematic review. Maturitas. 2012 Oct;73(2):94-114. doi: 10.1016/j.maturitas.2012.06.010. Epub 2012 Jul 17.

Reference Type BACKGROUND
PMID: 22809497 (View on PubMed)

Bateni H, Maki BE. Assistive devices for balance and mobility: benefits, demands, and adverse consequences. Arch Phys Med Rehabil. 2005 Jan;86(1):134-45. doi: 10.1016/j.apmr.2004.04.023.

Reference Type BACKGROUND
PMID: 15641004 (View on PubMed)

Polesel FS, Denadai S, Aliberti MJR, Morinaga CV, Andrade-Junior MC, Madalena IC, Yamaguti WP, Curiati PK, Righetti RF. Training and provision of mobility aids to promote autonomy and mobility of older patients in a geriatric emergency department: A protocol for a randomized controlled trial. PLoS One. 2024 Jul 31;19(7):e0304397. doi: 10.1371/journal.pone.0304397. eCollection 2024.

Reference Type DERIVED
PMID: 39083494 (View on PubMed)

Other Identifiers

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AVAP-NG 2999

Identifier Type: -

Identifier Source: org_study_id

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