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

Primary Purpose

Mobility Limitation

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Walking aid
Telemonitoring
Guidance on safe walking and risk of falling
Sponsored by
Hospital Sirio-Libanes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mobility Limitation focused on measuring Geriatric, Life space, Walking aids, Emergency room, Clinical Trial, Mobility

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital Sírio LibanêsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Walking aid (WA) group

Walking aid with telemonitoring (WAT) group

Control group

Arm Description

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

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

Participants will receive verbal guidance and printed material.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Timed Up and Go test (TUG)
TUG evaluate mobility, balance, gait, and risk of falling
One-minute sit-to-stand test
Functional capacity assessment by sit and stand completely in a chair (as often as possible during 1 minute)
Katz index
Katz index is a scale which evaluate basic activities of daily living
Barthel index
Barthel index is a scale which evaluates the autonomy for self-care, in addition to mobility
Lawton-Brody scale
Lawton-Brody scale evaluate Instrumental activities of daily living
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
Falls Efficacy Scale International (FES-I)
Assesses fear of falling
Geriatric Depression Scale (GDS-15)
Assesses mood disorders
10-Point Cognitive Screener (10-CS)
10-CS consists of a brief cognitive screening which evaluate temporal orientation, verbal fluency and three-word recall
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

Full Information

First Posted
July 10, 2023
Last Updated
October 2, 2023
Sponsor
Hospital Sirio-Libanes
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1. Study Identification

Unique Protocol Identification Number
NCT05950269
Brief Title
Walking Aid and Locomotion Knowledge in Emergency Rooms (WALKER 1) for Elderly People
Acronym
WALKER 1
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
August 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Sirio-Libanes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation
Keywords
Geriatric, Life space, Walking aids, Emergency room, Clinical Trial, Mobility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Walking aid (WA) group
Arm Type
Experimental
Arm Description
Participants will receive the walking aid and training in the use of the device.
Arm Title
Walking aid with telemonitoring (WAT) group
Arm Type
Experimental
Arm Description
Participants will receive the walking aid and training in the use of the device associated with telemonitoring.
Arm Title
Control group
Arm Type
Other
Arm Description
Participants will receive verbal guidance and printed material.
Intervention Type
Device
Intervention Name(s)
Walking aid
Intervention Description
A physiotherapist will identify the mobility needs and will indicate the most appropriate walking aid (cane or walker).
Intervention Type
Other
Intervention Name(s)
Telemonitoring
Intervention Description
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
Intervention Name(s)
Guidance on safe walking and risk of falling
Intervention Description
Participants will receive verbal guidance and printed material with guidance on safe walking and fall prevention.
Primary Outcome Measure Information:
Title
Life-Space Assessment (LSA)
Description
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
Time Frame
At baseline and after completion of the 3 months intervention to assess change
Secondary Outcome Measure Information:
Title
Timed Up and Go test (TUG)
Description
TUG evaluate mobility, balance, gait, and risk of falling
Time Frame
At baseline, after intervention and after completion of the 3 months intervention to assess change
Title
One-minute sit-to-stand test
Description
Functional capacity assessment by sit and stand completely in a chair (as often as possible during 1 minute)
Time Frame
At baseline and after completion of the 3 months intervention to assess change
Title
Katz index
Description
Katz index is a scale which evaluate basic activities of daily living
Time Frame
At baseline and after completion of the 3 months intervention to assess change
Title
Barthel index
Description
Barthel index is a scale which evaluates the autonomy for self-care, in addition to mobility
Time Frame
At baseline and after completion of the 3 months intervention to assess change
Title
Lawton-Brody scale
Description
Lawton-Brody scale evaluate Instrumental activities of daily living
Time Frame
At baseline and after completion of the 3 months intervention to assess change
Title
Euro Quality of Life Instrument-5D (EQ-5D)
Description
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
Time Frame
At baseline and after completion of the 3 months intervention to assess change
Title
Falls Efficacy Scale International (FES-I)
Description
Assesses fear of falling
Time Frame
At baseline, after intervention and after completion of the 3 months intervention to assess change
Title
Geriatric Depression Scale (GDS-15)
Description
Assesses mood disorders
Time Frame
At baseline and after completion of the 3 months intervention to assess change
Title
10-Point Cognitive Screener (10-CS)
Description
10-CS consists of a brief cognitive screening which evaluate temporal orientation, verbal fluency and three-word recall
Time Frame
At baseline and after completion of the 3 months intervention to assess change
Title
Fall History
Description
Fall history evaluate occurrence of falls (including data location, associated injuries, need for special care after the fall) and the total number of falls
Time Frame
At baseline and after completion of the 3 months intervention to assess change

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renato F Righetti, PhD
Email
refragar@gmail.com
Facility Information:
Facility Name
Hospital Sírio Libanês
City
São Paulo
ZIP/Postal Code
01308-050
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renato F Righetti, PhD
Email
refragar@gmail.com
First Name & Middle Initial & Last Name & Degree
Renato F Righetti, PhD
First Name & Middle Initial & Last Name & Degree
Pedro K Curiati, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
29254407
Citation
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.
Results Reference
background
PubMed Identifier
20159128
Citation
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.
Results Reference
background
PubMed Identifier
27288857
Citation
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.
Results Reference
background
PubMed Identifier
22809497
Citation
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.
Results Reference
background
PubMed Identifier
15641004
Citation
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.
Results Reference
background

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

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