Mobility LimitationWALKER 1NCT05950269
Walking Aid and Locomotion Knowledge in Emergency Rooms (WALKER 1) for Elderly People
A study testing Walking aid, Telemonitoring and Guidance on safe walking and risk of falling in people with Mobility Limitation, run by Hospital Sirio-Libanes at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mobility Limitation
- What is being tested?
- Walking aid, Telemonitoring and Guidance on safe walking and risk of falling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Jul 2023to 28 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Mobility Limitation
- Being tested
- Walking aid, Telemonitoring, Guidance on safe walking and risk of falling
- Keywords
- Geriatric, Life space, Walking aids, Emergency room, Clinical Trial, Mobility
- Medical subject headings
- Mobility Limitation, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking aidDevice
A physiotherapist will identify the mobility needs and will indicate the most appropriate walking aid (cane or walker).
TelemonitoringOther
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 fallingOther
Participants will receive verbal guidance and printed material with guidance on safe walking and fall prevention.
| Study group | Role | What they receive |
|---|---|---|
| Walking aid (WA) group | Experimental | Participants will receive the walking aid and training in the use of the device. Receives: Device: Walking aid; Other: Guidance on safe walking and risk of falling |
| Walking aid with telemonitoring (WAT) group | Experimental | Participants will receive the walking aid and training in the use of the device associated with telemonitoring. Receives: Device: Walking aid; Other: Telemonitoring; Other: Guidance on safe walking and risk of falling |
| Control group | Other | Participants will receive verbal guidance and printed material. Receives: Other: Guidance on safe walking and risk of falling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: At baseline, immediately after the intervention and after completion of the 3 and 6 months intervention to assess change
Secondary outcomes (9)
Timed Up and Go test (TUG)
TUG evaluate mobility, balance, gait, and risk of falling
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline and after completion of the 3 and 6 months intervention to assess change
Geriatric Depression Scale (GDS-15)
Assesses mood disorders
Measured: 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
Measured: 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
Measured: At baseline and after completion of the 3 and 6 months intervention to assess change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start31 Jul 2023
- Primary completion28 Dec 2024
- Study completion28 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950269
- Sponsor's protocol ID
- AVAP-NG 2999
- Acronym
- WALKER 1
- Status last verified
- Apr 2025
- First submitted
- 10 Jul 2023
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29254407Shimada 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.
PubMed 20159128Brown 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.
PubMed 27288857van 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.
PubMed 22809497Bateni 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.
PubMed 15641004Polesel FS, Denadai S, Morinaga CV, Madalena IC, Aliberti MJR, Henrique EA, de Andrade-Junior MC, Nucci RAB, Yamaguti WP, Curiati PK, Righetti RF. Walking Aids and Locomotion Training in the Emergency Department: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2544535. doi: 10.1001/jamanetworkopen.2025.44535.
PubMed 41269694Polesel FS, Denadai S, Aliberti MJR, Morinaga CV, Andrade-Junior MC, Madalena IC, Yamaguti WP, Curiati PK, Righetti RF. Training and provision of mobility aids to promote autonomy and mobility of older patients in a geriatric emergency department: A protocol for a randomized controlled trial. PLoS One. 2024 Jul 31;19(7):e0304397. doi: 10.1371/journal.pone.0304397. eCollection 2024.
PubMed 39083494
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05950269
- Acronym / sponsor ID
- WALKER 1 / AVAP-NG 2999
- Conditions
- Mobility Limitation
- Keywords
- Geriatric, Life space, Walking aids, Emergency room, Clinical Trial, Mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 28 Dec 2024 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Walking aid (WA) group | Experimental | Device: Walking aid, Other: Guidance 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) group | Experimental | Device: Walking aid, Other: Telemonitoring, Other: Guidance on safe walking and risk of fallingParticipants will receive the walking aid and training in the use of the device associated with telemonitoring. |
| Control group | Other | Other: Guidance on safe walking and risk of fallingParticipants will receive verbal guidance and printed material. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- Altered level of conscience
- need for supplemental oxygen (≥3L/min)
- respiratory distress
- hemodynamic instability
- postural instability with a tendency to fall backward
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking aidA physiotherapist will identify the mobility needs and will indicate the most appropriate walking aid (cane or walker). | Device | Walking aid (WA) group, Walking aid with telemonitoring (WAT) group |
| TelemonitoringTelemonitoring 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 | Walking aid with telemonitoring (WAT) group |
| Guidance on safe walking and risk of fallingParticipants will receive verbal guidance and printed material with guidance on safe walking and fall prevention. | Other | Control group, Walking aid (WA) group, Walking aid with telemonitoring (WAT) group |
Primary outcome
Life-Space Assessment (LSA)
Time frame: 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)
Time frame: At baseline, immediately after the intervention and after completion of the 3 and 6 months intervention to assess change
Assesses fear of falling
9 secondary outcomes
Timed Up and Go test (TUG)
Time frame: At baseline and immediately after the intervention
One-minute sit-to-stand test
Time frame: At baseline and after completion of the 3 and 6 months intervention to assess change
Katz index
Time frame: At baseline and after completion of the 3 and 6 months intervention to assess change
Barthel index
Time frame: At baseline and after completion of the 3 and 6 months intervention to assess change
Lawton-Brody scale
Time frame: At baseline and after completion of the 3 and 6 months intervention to assess change
Euro Quality of Life Instrument-5D (EQ-5D)
Time frame: At baseline and after completion of the 3 and 6 months intervention to assess change
Geriatric Depression Scale (GDS-15)
Time frame: At baseline and after completion of the 3 and 6 months intervention to assess change
10-Point Cognitive Screener (10-CS)
Time frame: At baseline and after completion of the 3 and 6 months intervention to assess change
Fall History
Time frame: At baseline and after completion of the 3 and 6 months intervention to assess change
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Background: PubMed 29254407Kennedy 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.
- Background: PubMed 20159128Shimada 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.
- Background: PubMed 27288857Brown 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.
- Background: PubMed 22809497van 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.
- Background: PubMed 15641004Bateni 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.
- Derived from this study: PubMed 41269694Polesel FS, Denadai S, Morinaga CV, Madalena IC, Aliberti MJR, Henrique EA, de Andrade-Junior MC, Nucci RAB, Yamaguti WP, Curiati PK, Righetti RF. Walking Aids and Locomotion Training in the Emergency Department: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2544535. doi: 10.1001/jamanetworkopen.2025.44535.
- Derived from this study: PubMed 39083494Polesel FS, Denadai S, Aliberti MJR, Morinaga CV, Andrade-Junior MC, Madalena IC, Yamaguti WP, Curiati PK, Righetti RF. Training and provision of mobility aids to promote autonomy and mobility of older patients in a geriatric emergency department: A protocol for a randomized controlled trial. PLoS One. 2024 Jul 31;19(7):e0304397. doi: 10.1371/journal.pone.0304397. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking aid, Telemonitoring and Guidance on safe walking and risk of falling in people with Mobility Limitation, run by Hospital Sirio-Libanes at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life-Space Assessment (LSA) (time frame: At baseline and after completion of the 3 and 6 months intervention to assess change). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05950269, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.