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Walking With the SAIRE Smart Walker (SAIRE)

Primary Purpose

Gait Disorders in Old Age, Gait Disorders, Neurologic, Walking, Difficulty

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
SAIRE smart walker
Standard 4-wheeled walker
No walking aid
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gait Disorders in Old Age

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • Brubotics Rehabilitation Research centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

SAIRE smart walker

Standard walker

No walking aid

Arm 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.

The comparator device consist of a standard 4-wheeled walker

Outcomes

Primary Outcome Measures

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.
Walking speed
Walking speed will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Cadence
Cadence will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Step length
Step length will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Step time
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
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
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
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
Double limb support period will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
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).

Secondary Outcome Measures

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.

Full Information

First Posted
July 6, 2022
Last Updated
November 23, 2022
Sponsor
Vrije Universiteit Brussel
Collaborators
Erasmus University Rotterdam, Odisee University College
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1. Study Identification

Unique Protocol Identification Number
NCT05461677
Brief Title
Walking With the SAIRE Smart Walker
Acronym
SAIRE
Official Title
Walking With the SAIRE Smart Walker
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel
Collaborators
Erasmus University Rotterdam, Odisee University College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait Disorders in Old Age, Gait Disorders, Neurologic, Walking, Difficulty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SAIRE smart walker
Arm Type
Experimental
Arm 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.
Arm Title
Standard walker
Arm Type
Active Comparator
Arm Description
The comparator device consist of a standard 4-wheeled walker
Arm Title
No walking aid
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
SAIRE smart walker
Intervention Description
Participants will walk along the 10-meter walkway 5 times using the SAIRE smart walker
Intervention Type
Device
Intervention Name(s)
Standard 4-wheeled walker
Intervention Description
Participants will walk along the 10-meter walkway 5 times using a standard 4-wheeled walker
Intervention Type
Other
Intervention Name(s)
No walking aid
Intervention Description
Participants will walk along the 10-meter walkway 5 times without using a walking aid
Primary Outcome Measure Information:
Title
3D kinematic measurements of the lower limb
Description
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.
Time Frame
At the end of the experimental session, Day 1
Title
Walking speed
Description
Walking speed will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Time Frame
At the end of the experimental session, Day 1
Title
Cadence
Description
Cadence will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Time Frame
At the end of the experimental session, Day 1
Title
Step length
Description
Step length will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Time Frame
At the end of the experimental session, Day 1
Title
Step time
Description
Step time will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Time Frame
At the end of the experimental session, Day 1
Title
Swing time of the lower limbs
Description
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.
Time Frame
At the end of the experimental session, Day 1
Title
Stance time
Description
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.
Time Frame
At the end of the experimental session, Day 1
Title
Single limb support period
Description
Single limb support period will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Time Frame
At the end of the experimental session, Day 1
Title
Double limb support period
Description
Double limb support period will be recorded continuously with the use of a 14-camera Vicon Vero 1.3 system at 100 Hz.
Time Frame
At the end of the experimental session, Day 1
Title
Electromyography
Description
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).
Time Frame
At the end of the experimental session, Day 1
Secondary Outcome Measure Information:
Title
User experience with a modified version of the USE questionnaire
Description
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.
Time Frame
At the end of the experimental session, Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruben Debeuf
Phone
0032478821658
Email
ruben.debeuf@vub.be
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Swinnen, Prof. Ph.D
Phone
003224774527
Email
eva.swinnen@vub.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Swinnen, Prof. Ph.D
Organizational Affiliation
Vrije Universiteit Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brubotics Rehabilitation Research center
City
Jette
State/Province
Brussels Hoofdstedelijk Gewest
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruben Debeuf
Phone
0032478821658
Email
ruben.debeuf@vub.be
First Name & Middle Initial & Last Name & Degree
Eva Swinnen, Prof. Ph.D
Phone
003224774527
Email
eva.swinnen@vub.be

12. IPD Sharing Statement

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Walking With the SAIRE Smart Walker

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