NCT06629922

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Oct 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Oct 2024Dec 2026

First Submitted

Initial submission to the registry

October 3, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

October 7, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2026

Last Updated

October 8, 2024

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

October 3, 2024

Last Update Submit

October 4, 2024

Conditions

Keywords

sensory interactionsensory reweightingolder adultsbalancefall riskfall

Outcome Measures

Primary Outcomes (2)

  • Instrumented CTSIB

    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

  • UHasselt Locomotor Sensory Integration Test

    This test was developed to evaluate sensory integration in locomotion.

    Baseline

Other Outcomes (1)

  • Center of Mass

    Baseline

Study Arms (2)

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

Other: No intervention

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

Other: No intervention

Interventions

This is a observational study and the participants will not receive any intervention

Older AdultsYoung Adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy young and older adults

You may qualify if:

  • 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.

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Diepenbeek, 3590, Belgium

Location

Central Study Contacts

Esma Nur Kolbasi Dogan, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

October 3, 2024

First Posted

October 8, 2024

Study Start

October 7, 2024

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

December 25, 2026

Last Updated

October 8, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations