Gait Disorders in Old AgeSAIRENCT05461677
Walking With the SAIRE Smart Walker
A study testing SAIRE smart walker, Standard 4-wheeled walker and No walking aid in people with Gait Disorders in Old Age and Gait Disorders, Neurologic, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
The current study aims to investigate the effect of walking with the SAIRE smart walker on spatiotemporal parameters and gait kinematics in a population who suffer from difficulties during gait, and compare this to walking with a standard walker or no walking aid. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gait Disorders in Old Age, Gait Disorders, Neurologic, Walking, Difficulty
- What is being tested?
- SAIRE smart walker, Standard 4-wheeled walker and No walking aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2022to 31 Dec 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to walk along a 10-meter walkway multiple times over a period of 120 minutes
- Ambulation with any sort of assistive device (e.g. cane, crutches, walker, etc.)
- Sufficient arm/hand function to walk with a walker
- Capable of understanding and carrying out instructions
- Capable of giving informed consent
Who cannot join
- Presence of cognitive impairement (MoCA score <23)
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Brubotics Rehabilitation Research center
Jette, Brussels Capital, 1090
About this study
The current study aims to investigate the effect of walking with the SAIRE smart walker on spatiotemporal parameters and gait kinematics in a population who suffer from difficulties during gait, and compare this to walking with a standard walker or no walking aid.
Read the detailed description
This study is an experimental single group study investigating the effect of walking with a smart walker compared to walking with a standard walker or no walking aid in persons who suffer from gait difficulties. Participants will perform one session of walking in three different conditions, (1) walking with the SAIRE smart walker, (2) walking with a standard walker and (3) if the participants are able to walk without the use of an assistive device, walking without a walker. During this session, gait parameters will be compared between the three conditions.
Experimental session: During the experimental session, participants will walk along the 10-meter walkway (5 times for every condition) After every 5 trials, a rest period of minimum 5 minutes will be held to avoid fatigue. Three different walking conditions will be measured: (1) walking with the SAIRE smart walker, (2) walking with a standard walker and if possible (3) walking with no walking aid. Each walking condition will be measured five consecutive times in a randomized order. The order of the conditions will be randomized using closed envelopes containing notes that say what order of conditions will be used. This randomization is done to avoid fatigue effects that might occur when a strict order is used.
Before the start of the experimental session, participants will practice using the SAIRE smart walker for maximum 10 minutes to familiarize with the feedback given by the walker. After this familiarization session, the surface electrodes and reflective markers will be placed on the participants and the experimental session will start.
Analysis: This study will investigate the difference in gait biomechanics of adults with gait difficulties while using different walking aids.
Descriptive statistics of the baseline characteristics of all participants will be performed. The effect of gait with a smart walker on spatiotemporal gait parameters, kinematics and muscle activity will be compared to gait with a standard 2-wheeled walker and gait without a walking aid. Data will be visualized using LO(W)ESS smoothing (locally weighted scatterplot smoothing) to explore the effect (per condition and outcome). Values will be compared between conditions in a one-way repeated measures analysis of variance. For the analysis of the USE questionnaire, percentage distribution of every item and mean scores for every subscale will be calculated using Microsoft Excel (Microsoft, Washington, DC).
- Being tested
- SAIRE smart walker, Standard 4-wheeled walker, No walking aid
- Medical subject headings
- Gait Disorders, Neurologic, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAIRE smart walkerDevice
Participants will walk along the 10-meter walkway 5 times using the SAIRE smart walker
Standard 4-wheeled walkerDevice
Participants will walk along the 10-meter walkway 5 times using a standard 4-wheeled walker
No walking aidOther
Participants will walk along the 10-meter walkway 5 times without using a walking aid
| Study group | Role | What they receive |
|---|---|---|
| SAIRE smart walker | Experimental | The investigational device used in this clinical investigation is called the SAIRE smart walker. This first prototype version is equipped with a depth camera and two cheaper cameras. The depth camera is used to acquire high-quality data to train artificial intelligence (AI) models which then can run on the cheaper camera modules. Additionally, two ultrasonic sensors are applied to estimate the distance. A touch monitor is used to provide audiovisual feedback and display the user interface. Two LED strips are also attached to the walker to provide additional visual feedback to the patient.
The SAIRE smart walker gives feedback to the patient in terms of cadence using a metronome, and foot placement using the LED strips and the video stream presented on the monitor. Additionally, the walker will give information about step length and step width through AI-models. Receives: Device: SAIRE smart walker |
| Standard walker | Active comparator | The comparator device consist of a standard 4-wheeled walker Receives: Device: Standard 4-wheeled walker |
| No walking aid | Active comparator | Not described Receives: Other: No walking aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D kinematic measurements of the lower limb
Kinematic data (i.e., movement amplitudes of the bilateral hip, knee and ankle joint) of the lower limbs during walking will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Measured: At the end of the experimental session, Day 1
Walking speed
Walking speed will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Measured: At the end of the experimental session, Day 1
Cadence
Cadence will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Measured: At the end of the experimental session, Day 1
Step length
Step length will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Measured: At the end of the experimental session, Day 1
Step time
Step time will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Measured: At the end of the experimental session, Day 1
Swing time of the lower limbs
Swing time of the lower limbs during walking will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Measured: At the end of the experimental session, Day 1
Stance time
Stance time of the lower limbs during walking will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Measured: At the end of the experimental session, Day 1
Single limb support period
Single limb support period will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Measured: At the end of the experimental session, Day 1
Double limb support period
Double limb support period will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Measured: At the end of the experimental session, Day 1
Electromyography
Muscle activity of the lower limb muscles (bilateral: M. rectus femoris, M. vastus lateralis, M. biceps femoris, M. tibialis anterior, M. gastrocnemius medialis) will be recorded continuously during treadmill walking with the use of surface electrodes. Signals will be recorded with the wireless Cometa Wave Plus EMG system (16 channels).
Measured: At the end of the experimental session, Day 1
Secondary outcomes (1)
User experience with a modified version of the USE questionnaire
User experience will be assessed using a translated version of the self-administered Usefulness, Satisfaction and Ease of use (USE) questionnaire. This scale ranges from 30 to 210, with a higher score translating to higher satisfaction. Additionally, open questions were added to the questionnaire to uncover possible barriers and facilitators in the use of the smart walker.
Measured: At the end of the experimental session, Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Disorders in Old AgeStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus University Rotterdam, Odisee University College
- Responsible party
- Principal investigator, Ruben Debeuf, Vrije Universiteit Brussel
- Investigators
- Eva Swinnen, Prof. Ph.D, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461677
- Sponsor's protocol ID
- SAIRE Smart Walker
- Acronym
- SAIRE
- Status last verified
- Apr 2025
- First submitted
- 6 Jul 2022
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking With the SAIRE Smart Walker
- ClinicalTrials.gov ID
- NCT05461677
- Acronym / sponsor ID
- SAIRE / SAIRE Smart Walker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- Erasmus University Rotterdam, Odisee University College
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 Jul 2022 (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.
The current study aims to investigate the effect of walking with the SAIRE smart walker on spatiotemporal parameters and gait kinematics in a population who suffer from difficulties during gait, and compare this to walking with a standard walker or no walking aid.
Detailed description
This study is an experimental single group study investigating the effect of walking with a smart walker compared to walking with a standard walker or no walking aid in persons who suffer from gait difficulties. Participants will perform one session of walking in three different conditions, (1) walking with the SAIRE smart walker, (2) walking with a standard walker and (3) if the participants are able to walk without the use of an assistive device, walking without a walker. During this session, gait parameters will be compared between the three conditions.
Experimental session: During the experimental session, participants will walk along the 10-meter walkway (5 times for every condition) After every 5 trials, a rest period of minimum 5 minutes will be held to avoid fatigue. Three different walking conditions will be measured: (1) walking with the SAIRE smart walker, (2) walking with a standard walker and if possible (3) walking with no walking aid. Each walking condition will be measured five consecutive times in a randomized order. The order of the conditions will be randomized using closed envelopes containing notes that say what order of conditions will be used. This randomization is done to avoid fatigue effects that might occur when a strict order is used.
Before the start of the experimental session, participants will practice using the SAIRE smart walker for maximum 10 minutes to familiarize with the feedback given by the walker. After this familiarization session, the surface electrodes and reflective markers will be placed on the participants and the experimental session will start.
Analysis: This study will investigate the difference in gait biomechanics of adults with gait difficulties while using different walking aids.
Descriptive statistics of the baseline characteristics of all participants will be performed. The effect of gait with a smart walker on spatiotemporal gait parameters, kinematics and muscle activity will be compared to gait with a standard 2-wheeled walker and gait without a walking aid. Data will be visualized using LO(W)ESS smoothing (locally weighted scatterplot smoothing) to explore the effect (per condition and outcome). Values will be compared between conditions in a one-way repeated measures analysis of variance. For the analysis of the USE questionnaire, percentage distribution of every item and mean scores for every subscale will be calculated using Microsoft Excel (Microsoft, Washington, DC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SAIRE smart walker | Experimental | Device: SAIRE smart walkerThe investigational device used in this clinical investigation is called the SAIRE smart walker. This first prototype version is equipped with a depth camera and two cheaper cameras. The depth camera is used to acquire high-quality data to train artificial intelligence (AI) models which then can run on the cheaper camera modules. Additionally, two ultrasonic sensors are applied to estimate the distance. A touch monitor is used to provide audiovisual feedback and display the user interface. Two LED strips are also attached to the walker to provide additional visual feedback to the patient. The SAIRE smart walker gives feedback to the patient in terms of cadence using a metronome, and foot placement using the LED strips and the video stream presented on the monitor. Additionally, the walker will give information about step length and step width through AI-models. |
| Standard walker | Active comparator | Device: Standard 4-wheeled walkerThe comparator device consist of a standard 4-wheeled walker |
| No walking aid | Active comparator | Other: No walking aid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to walk along a 10-meter walkway multiple times over a period of 120 minutes
- Ambulation with any sort of assistive device (e.g. cane, crutches, walker, etc.)
- Sufficient arm/hand function to walk with a walker
- Capable of understanding and carrying out instructions
- Capable of giving informed consent
Key exclusion criteria (1 listed)
- Presence of cognitive impairement (MoCA score <23)
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 |
|---|---|---|
| SAIRE smart walkerParticipants will walk along the 10-meter walkway 5 times using the SAIRE smart walker | Device | SAIRE smart walker |
| Standard 4-wheeled walkerParticipants will walk along the 10-meter walkway 5 times using a standard 4-wheeled walker | Device | Standard walker |
| No walking aidParticipants will walk along the 10-meter walkway 5 times without using a walking aid | Other | No walking aid |
Primary outcome
3D kinematic measurements of the lower limb
Time frame: At the end of the experimental session, Day 1
Kinematic data (i.e., movement amplitudes of the bilateral hip, knee and ankle joint) of the lower limbs during walking will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Walking speed
Time frame: At the end of the experimental session, Day 1
Walking speed will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Cadence
Time frame: At the end of the experimental session, Day 1
Cadence will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Step length
Time frame: At the end of the experimental session, Day 1
Step length will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Step time
Time frame: At the end of the experimental session, Day 1
Step time will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Swing time of the lower limbs
Time frame: At the end of the experimental session, Day 1
Swing time of the lower limbs during walking will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Stance time
Time frame: At the end of the experimental session, Day 1
Stance time of the lower limbs during walking will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Single limb support period
Time frame: At the end of the experimental session, Day 1
Single limb support period will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Double limb support period
Time frame: At the end of the experimental session, Day 1
Double limb support period will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Electromyography
Time frame: At the end of the experimental session, Day 1
Muscle activity of the lower limb muscles (bilateral: M. rectus femoris, M. vastus lateralis, M. biceps femoris, M. tibialis anterior, M. gastrocnemius medialis) will be recorded continuously during treadmill walking with the use of surface electrodes. Signals will be recorded with the wireless Cometa Wave Plus EMG system (16 channels).
1 secondary outcome
User experience with a modified version of the USE questionnaire
Time frame: At the end of the experimental session, Day 1
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 4 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Eva Swinnen, Prof. Ph.D principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAIRE smart walker, Standard 4-wheeled walker and No walking aid in people with Gait Disorders in Old Age and Gait Disorders, Neurologic, run by Vrije Universiteit Brussel at 1 site in Belgium.
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 5 inclusion and 1 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 4 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 Belgium. 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?
3D kinematic measurements of the lower limb (time frame: At the end of the experimental session, Day 1). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2025.