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

Study Overview
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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.

Official Title
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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

Conditions
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Mobility Limitation

Intervention / Treatment
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* Device: Walking aid
* Other: Telemonitoring
* Other: Guidance on safe walking and risk of falling


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walking aid (WA) group<br>Participants will receive the walking aid and training in the use of the device. | Device: Walking aid<br>* A physiotherapist will identify the mobility needs and will indicate the most appropriate walking aid (cane or walker).<br>Other: Guidance on safe walking and risk of falling<br>* Participants will receive verbal guidance and printed material with guidance on safe walking and fall prevention.<br>|
| Experimental: Walking aid with telemonitoring (WAT) group<br>Participants will receive the walking aid and training in the use of the device associated with telemonitoring. | Device: Walking aid<br>* A physiotherapist will identify the mobility needs and will indicate the most appropriate walking aid (cane or walker).<br>Other: Telemonitoring<br>* 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.<br>Other: Guidance on safe walking and risk of falling<br>* Participants will receive verbal guidance and printed material with guidance on safe walking and fall prevention.<br>|
| Other: Control group<br>Participants will receive verbal guidance and printed material. | Other: Guidance on safe walking and risk of falling<br>* Participants will receive verbal guidance and printed material with guidance on safe walking and fall prevention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life-Space Assessment (LSA) | 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) | 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) | TUG evaluate mobility, balance, gait, and risk of falling | At baseline and immediately after the intervention | 
| One-minute sit-to-stand test | 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 | 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 | 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 | 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) | 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) | Assesses mood disorders | At baseline and after completion of the 3 and 6 months intervention to assess change | 
| 10-Point Cognitive Screener (10-CS) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Geriatric, Life space, Walking aids, Emergency room, Clinical Trial, Mobility