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Completed

NCT Number: NCT05950269

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

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.

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Key information

Conditions

Mobility Limitation Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sírio Libanês

São Paulo, 01308-050, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walking aid

Device

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

Telemonitoring

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

Other

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Timed Up and Go test (TUG)

    Time frame: At baseline and immediately after the intervention

    TUG evaluate mobility, balance, gait, and risk of falling

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

Hospital Sirio-Libanes

Other

Registry information

Official study title

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

Acronym: WALKER 1

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2023
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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