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

Mobility Limitation Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05950269
• Other study ID #: AVAP-NG 2999
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2023
• Est. completion date: August 28, 2025

Study information

• Verified date: June 2023
• Source: Hospital Sirio-Libanes
• Contact: Renato F Righetti, PhD
• Email: refragar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 153
• Est. completion date: August 28, 2025
• Est. primary completion date: December 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Mobility Limitation

Intervention

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.
• Guidance on safe walking and risk of falling
Participants will receive verbal guidance and printed material with guidance on safe walking and fall prevention.

Locations

Country	Name	City	State
Brazil	Hospital Sírio Libanês	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sirio-Libanes

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Timed Up and Go test (TUG)	TUG evaluate mobility, balance, gait, and risk of falling	At baseline and immediately after the intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Geriatric Depression Scale (GDS-15)	Assesses mood disorders	At baseline and after completion of the 3 and 6 months intervention to assess change
Secondary	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
Secondary	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