Clinical trial NCT05461677: Walking With the SAIRE Smart Walker
Official title: Walking With the SAIRE Smart Walker
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait Disorders in Old Age
Gait Disorders, Neurologic
Walking, Difficulty
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
Collaborators: name: Erasmus University Rotterdam
name: Odisee University College
First posted: 2022-07-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: 3D kinematic measurements of the lower limb
timeFrame: At the end of the experimental session, Day 1
measure: Walking speed
timeFrame: At the end of the experimental session, Day 1
measure: Cadence
timeFrame: At the end of the experimental session, Day 1
measure: Step length
timeFrame: At the end of the experimental session, Day 1
measure: Step time
timeFrame: At the end of the experimental session, Day 1
measure: Swing time of the lower limbs
timeFrame: At the end of the experimental session, Day 1
measure: Stance time
timeFrame: At the end of the experimental session, Day 1
measure: Single limb support period
timeFrame: At the end of the experimental session, Day 1
measure: Double limb support period
timeFrame: At the end of the experimental session, Day 1
measure: Electromyography
timeFrame: At the end of the experimental session, Day 1
Secondary outcomes:
measure: User experience with a modified version of the USE questionnaire
timeFrame: At the end of the experimental session, Day 1
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Brubotics Rehabilitation Research center
state: Brussels Hoofdstedelijk Gewest
Study officials:
affiliation: Vrije Universiteit Brussel
name: Eva Swinnen, Prof. Ph.D
role: PRINCIPAL_INVESTIGATOR
References: