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

Sponsor
Hospital Sirio-Libanes (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05950269
Collaborator
(none)
75
1
3
12.9
5.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Walking aid
  • Other: Telemonitoring
  • Other: Guidance on safe walking and risk of falling
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Treatment
Official 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
Anticipated Study Start Date :
Jul 31, 2023
Anticipated Primary Completion Date :
Feb 28, 2024
Anticipated Study Completion Date :
Aug 28, 2024

Arms and Interventions

Arm Intervention/Treatment
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: 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: 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: 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.

Outcome Measures

Primary Outcome Measures

  1. Life-Space Assessment (LSA) [At baseline and after completion of the 3 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

Secondary Outcome Measures

  1. Timed Up and Go test (TUG) [At baseline, after intervention and after completion of the 3 months intervention to assess change]

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

  2. One-minute sit-to-stand test [At baseline and after completion of the 3 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 [At baseline and after completion of the 3 months intervention to assess change]

    Katz index is a scale which evaluate basic activities of daily living

  4. Barthel index [At baseline and after completion of the 3 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 [At baseline and after completion of the 3 months intervention to assess change]

    Lawton-Brody scale evaluate Instrumental activities of daily living

  6. Euro Quality of Life Instrument-5D (EQ-5D) [At baseline and after completion of the 3 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. Falls Efficacy Scale International (FES-I) [At baseline, after intervention and after completion of the 3 months intervention to assess change]

    Assesses fear of falling

  8. Geriatric Depression Scale (GDS-15) [At baseline and after completion of the 3 months intervention to assess change]

    Assesses mood disorders

  9. 10-Point Cognitive Screener (10-CS) [At baseline and after completion of the 3 months intervention to assess change]

    10-CS consists of a brief cognitive screening which evaluate temporal orientation, verbal fluency and three-word recall

  10. Fall History [At baseline and after completion of the 3 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Renato Fraga Righetti São Paulo Brazil 05547-070

Sponsors and Collaborators

  • Hospital Sirio-Libanes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hospital Sirio-Libanes
ClinicalTrials.gov Identifier:
NCT05950269
Other Study ID Numbers:
  • AVAP-NG 2999
First Posted:
Jul 18, 2023
Last Update Posted:
Jul 18, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospital Sirio-Libanes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 18, 2023