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Completed

NCT Number: NCT05461677

Walking With the SAIRE Smart Walker

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brubotics Rehabilitation Research center

Jette, Brussels Capital, 1090, Belgium

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SAIRE smart walker

Device

Participants will walk along the 10-meter walkway 5 times using the SAIRE smart walker

Standard 4-wheeled walker

Device

Participants will walk along the 10-meter walkway 5 times using a standard 4-wheeled walker

No walking aid

Other

Participants will walk along the 10-meter walkway 5 times without using a walking aid

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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).

Secondary outcomes

  1. User experience with a modified version of the USE questionnaire

    Time frame: At the end of the experimental session, Day 1

    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.

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Collaborators

  • Erasmus University Rotterdam
  • Odisee University College

Registry information

Acronym: SAIRE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2022
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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