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

Not Applicable
Completed
Conditions
Mobility Limitation
Interventions
Device: Walking aid
Other: Guidance on safe walking and risk of falling
Other: Telemonitoring
Registration Number
NCT05950269
Lead Sponsor
Hospital Sirio-Libanes
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
153
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Walking aid with telemonitoring (WAT) groupWalking aidParticipants will receive the walking aid and training in the use of the device associated with telemonitoring.
Control groupGuidance on safe walking and risk of fallingParticipants will receive verbal guidance and printed material.
Walking aid (WA) groupWalking aidParticipants will receive the walking aid and training in the use of the device.
Walking aid with telemonitoring (WAT) groupTelemonitoringParticipants will receive the walking aid and training in the use of the device associated with telemonitoring.
Walking aid (WA) groupGuidance on safe walking and risk of fallingParticipants will receive the walking aid and training in the use of the device.
Walking aid with telemonitoring (WAT) groupGuidance on safe walking and risk of fallingParticipants will receive the walking aid and training in the use of the device associated with telemonitoring.
Primary Outcome Measures
NameTimeMethod
Life-Space Assessment (LSA)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

Falls Efficacy Scale International (FES-I)At baseline, immediately after the intervention and after completion of the 3 and 6 months intervention to assess change

Assesses fear of falling

Secondary Outcome Measures
NameTimeMethod
Geriatric Depression Scale (GDS-15)At baseline and after completion of the 3 and 6 months intervention to assess change

Assesses mood disorders

10-Point Cognitive Screener (10-CS)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

Fall HistoryAt 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

Timed Up and Go test (TUG)At baseline and immediately after the intervention

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

Katz indexAt 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

Lawton-Brody scaleAt baseline and after completion of the 3 and 6 months intervention to assess change

Lawton-Brody scale evaluate Instrumental activities of daily living

Euro Quality of Life Instrument-5D (EQ-5D)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

One-minute sit-to-stand testAt 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)

Barthel indexAt 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

Trial Locations

Locations (1)

Hospital Sírio Libanês

🇧🇷

São Paulo, Brazil

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