Walking With the SAIRE Smart Walker

Gait Disorders, Neurologic Clinical Trial

— SAIRE  

Official title:

Walking With the SAIRE Smart Walker

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05461677
• Other study ID #: SAIRE Smart Walker
• Status: Recruiting
• Phase: N/A
• Start date: November 2022
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: Vrije Universiteit Brussel
• Contact: Ruben Debeuf
• Phone: 0032478821658
• Email: ruben.debeuf[@]vub.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Disease
• Gait Disorders in Old Age
• Gait Disorders, Neurologic
• Mobility Limitation
• Nervous System Diseases
• Walking, Difficulty

Intervention

Device:
• SAIRE smart walker
Participants will walk along the 10-meter walkway 5 times using the SAIRE smart walker
• Standard 4-wheeled walker
Participants will walk along the 10-meter walkway 5 times using a standard 4-wheeled walker

Other:
• No walking aid
Participants will walk along the 10-meter walkway 5 times without using a walking aid

Locations

Country	Name	City	State
Belgium	Brubotics Rehabilitation Research center	Jette	Brussels Hoofdstedelijk Gewest

Sponsors (3)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel	Erasmus University Rotterdam, Odisee University College

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	At the end of the experimental session, Day 1