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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05461677
Other study ID # SAIRE Smart Walker
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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