- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06629922
Sensory Interaction and Balance Control During Standing and Walking in Healthy Young and Older Adults
Sensory Interaction and Balance Control During Standing and Walking Under Challenging Conditions in Healthy Young and Older Adults
This project is designed to: a) develop a new test called UHasselt Locomotor Sensory Integration Test (UHLSINT) which would allow us to evaluate sensory interaction process in locomotion assess whether Locomotor CTSIB and to investigate whether UHLSINT is a reliable test to evaluate sensory interaction in both young and older adults, b) evaluate the difference in sensory interaction and balance performance between standing and walking between both young and older adults, c) examine the changes in sensory interaction process under challenging conditions such as perturbations, dual-task, and when both are present between both young and older adults, d) examine the association between overall fall risk defined by the single-large perturbations and sensory interaction processes used during all the trials in both age groups.
In order to achieve these aims, 10 trials will be conducted:
Trial 1- Single-Large Perturbation in Standing Trial 2- Single-Large Perturbation in Walking Trial 3- Instrumented CTSIB Trial 4- Locomotor CTSIB Trial 5- Instrumented CTSIB + Perturbations Trial 6- Locomotor CTSIB + Perturbations Trial 7- Instrumented CTSIB + Auditory Stroop Test Trial 8- Locomotor CTSIB + Auditory Stroop Test Trial 9- Instrumented CTSIB + Perturbations + Auditory Stroop Test Trial 10- Locomotor CTSIB + Perturbations + Auditory Stroop Test
Two different treadmill perturbations will be applied in addition to the Instrumented CTSIB and UHLSINT: a) slip perturbations, b) continuous perturbations. An auditory stroop task will be applied in relevant trials.
All of the trials will be performed in CAREN High-End Systems (Motek Medical BV, Amsterdam, The Netherlands) which is a motion capture system that is equipped with a treadmill mounted on a 6 degree of freedom motion base, a 360º dome-shaped virtual reality (VR) screen, and a marker-based movement analysis system.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Esma Nur Kolbasi Dogan, PhD
- Phone Number: +32 11 268050
- Email: esma.kolbasidogan@uhasselt.be
Study Locations
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-
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Diepenbeek, Belgium, 3590
- Hasselt University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Young adults who: a) aged between 18 to 35 years old and, b) have never been diagnosed with somatosensory, visual, and vestibular deficits as reported by the participants, will be invited to participate. Community-dwelling older adults who: a) are 65 years old and over and, b) have not fallen in the last 12 months will also be invited to participate.
Exclusion Criteria:
- having had serious lower extremity injuries or operations in the past year,
- having any neurological (stroke, epilepsy, Parkinson's disease, etc.), sensory (i.e. peripheral neuropathy, diminished sense of pain, etc.) or motor disorder that can interfere with the results of the study
- Diagnosed vascular, respiratory, cardiac, orthopedic, or other disorders that affect the subject's ability to exercise safely,
- Medication affecting exercise tolerance. Additionally, based on the CAREN High-End Systems contraindications and risk factors the following exclusion criteria will be applied to the participants: a) a body weight higher than the 135 kg, b) an inability to properly adjust the harness to the respective body part due to pregnancy, colostomy bags, skin lesions that cannot be protected appropriately and any other reason that prevents a proper, pain-free adjustment of the harness.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Young Adults
a) aged between 18 to 35 years old and, b) have never been diagnosed with somatosensory, visual, and vestibular deficits as reported by the participants
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This is a observational study and the participants will not receive any intervention
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|
Older Adults
a) are 65 years old and over and, b) have not fallen in the last 12 months will also be invited to participate
|
This is a observational study and the participants will not receive any intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Instrumented CTSIB
Time Frame: Baseline
|
The Clinical Test of Sensory Integration and Balance (CTSIB) is a tool used to evaluate a person's sensory integration process by manipulating different sensory inputs. It assesses how well the body uses three main sensory systems-visual, vestibular, and proprioceptive inputs-to maintain postural control. Six conditions are included in the test, each progressively altering the availability of sensory information: Condition 1: Eyes Open, Firm Surface Condition 2: Eyes Closed, Firm Surface Condition 3: Eyes Open, Foam Surface Condition 4: Eyes Closed, Foam Surface Condition 5: Visual Conflict, Firm Surface Condition 6: Visual Conflict, Foam Surface |
Baseline
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UHasselt Locomotor Sensory Integration Test
Time Frame: Baseline
|
This test was developed to evaluate sensory integration in locomotion.
|
Baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Center of Mass
Time Frame: Baseline
|
Center of mass displacement changes between the trials will be compared to achieve the aims of the study.
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Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HasseltU100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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