Walking With the SAIRE Smart Walker

Vrije Universiteit Brussel

Status

Completed

Conditions

Gait Disorders, Neurologic

Walking, Difficulty

Gait Disorders in Old Age

Treatments

Other: No walking aid

Device: SAIRE smart walker

Device: Standard 4-wheeled walker

Study type

Interventional

Funder types

Other

Identifiers

NCT05461677

SAIRE Smart Walker

Details and patient eligibility

About

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.

Full 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).

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Presence of cognitive impairement (MoCA score <23)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 3 patient groups

SAIRE smart walker

Experimental group

Description:

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.

Treatment:

Device: SAIRE smart walker

Standard walker

Active Comparator group

Description:

The comparator device consist of a standard 4-wheeled walker

Treatment:

Device: Standard 4-wheeled walker

No walking aid

Active Comparator group

Treatment:

Other: No walking aid