Walking With the SAIRE Smart Walker

NCT05461677 | Completed

• 1 other identifier: SAIRE Smart Walker
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  At the end of the experimental session, Day 1

Secondary Outcomes (1)

• User experience with a modified version of the USE questionnaire

  At the end of the experimental session, Day 1

Study Arms (3)

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.

Device: SAIRE smart walker

Standard walker

ACTIVE COMPARATOR

The comparator device consist of a standard 4-wheeled walker

Device: Standard 4-wheeled walker

No walking aid

ACTIVE COMPARATOR

Other: No walking aid

Interventions

SAIRE smart walker DEVICE

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

SAIRE smart walker

Standard 4-wheeled walker DEVICE

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

Standard walker

No walking aid OTHER

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

No walking aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Presence of cognitive impairement (MoCA score \<23)

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Erasmus University Rotterdam: collaborator
• Odisee University College: collaborator

Study Sites (1)

Brubotics Rehabilitation Research center

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic; Mobility Limitation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eva Swinnen, Prof. Ph.D

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 18, 2022
• Study Start: September 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)