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Recruiting Observational

Gait and Postural Balance Analysis During Head-motion Perturbed Standing and Walking in Older Adults

NCT06345625 · tracked via the Priya Life Science Belgium tracker
Phase
Observational
Started
2024-05-07
Last updated
2024-05-09

Condition(s) studied

AgedAccidental FallPostural BalanceGait

Investigational drug(s) / intervention(s)

CognitionSensory functionFrailtyBiomechanical movement analysisScreeningFollow up

Cognition: 1. The CatchU® app quantitatively and objectively measures the ability to integrate visual-somatosensory information using reaction time test data. 2. Digit Symbol Substitution test assesses processing speed and attention by requiring individuals to match symbols with corresponding numbers within a specified time frame. 3. Trail Making Test part 1 and 2: assesses cognitive flexibility, visual attention, and task-switching by having individuals connect numbered circles in sequence (part 1) and then alternate between numbers and letters (Part 2). 4. Go/No Go test measures an individual's ability to inhibit a prepotent response (No-Go) and execute a response when required (Go). This test provides insights into executive functioning, particularly inhibitory control.

Sensory function: 1. Cervical Sensorimotor control will be measured through a wireless wearable sensor 3D-cervical trainer by Sensamove on the placed on the head of the participant. The 3DCT registers cervical position sense by the Head Repositioning Accuracy test where the subject must relocate the head to the previously memorized (neutral) head position with the eyes closed and the joint position error degrees are registered. Cervical movement sense is examined using 'The Fly'-test where the subject ought to follow a movement pattern displayed on the screen in front of them. The movement of the neck-head unit is there upon tracked by the 3DCT and projected on the screen. 2. Vestibular function will be assessed through 3D-video Head Impulse Testing (vHIT), examining the state of the three semicircular canals by delivering the vestibulo-ocular reflex (vor) gain and vor gain asymmetry. 3. For the assessment of static and dynamic visual acuity, functional Head Impulse Testing (fHIT) will be used.

Frailty: Frailty will be assessed using the Fried criteria, comprising 5 categories (each accounting for 1 point if scored positive): Unintentional weight loss (interview), weakness (grip strength with hand-held dynamometer), poor endurance and energy (two statements of the CES-D Depression Scale), slowness (walking speed over 15ft through gait analysis) and low physical activity level (Minnesota Leisure Time Activity questionnaire)(Fried et al., 2001).

Biomechanical movement analysis: Markers will be placed on the predefined anatomical locations and surface electrodes for electromyography will be applied at the predefined muscle locations following the SENIAM-guidelines. The Microsoft HoloLens 2 is fixated on the participant's head which will, on one hand, provide the cue to the participant for the head movement and on the other hand track eye and head movements. A safety harness is attached to the body and the ceiling of the lab. At the start of the trial, the subject will see a projection by the HoloLens 2 on the real environment moving to the left; right; upward; downward (cue in randomized order) which the participant is ought to follow with eyes and head. First while standing still and second while walking the 10-meter overground walkway at a self-preferred walking speed.

Screening: The researcher will visit the possible participants (at their home, community centre, etc.) and after written consent on screening procedure is provided, the tests for eligibility will be performed. 1. Interview: asking about age (years), gender (male/female), medical history and the number of falls in the last 12 months . 2. Timed Up-and-Go (TUG) to check walking ability. TUG is a sensitive and specific measure for identifying risk for falls (Shumway-Cook et al., 2000).

Follow up: Participants are followed up for 12 months. They fill in a fall diary and telephone reminders will be performed monthly to encourage participants to complete and return their diaries.

Study summary

The main aim of this study is to unravel the biomechanics of postural balance reactions during head-motion perturbed standing and walking in older adults who fall, while integrating the influence of frailty, sensory functioning and cognitive processing.

Eligibility

Sex
ALL
Min age
65 Years
Max age
100 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Community dwelling * an age of 65 years or above Exclusion Criteria: * age \< 65 years * medical history encompassing diagnosed vestibulopathy, orthostatic hypotension, peripheral neuropathy, limb amputation, neurological or neuromuscular disorders affecting balance, diagnosed neck disorders affecting sensorimotor control, blindness, deafness * a full-time walking aid is indispensable.

Primary outcome measure(s)

  • Spatio-temporal parameters of gait — baseline
    step length and width (cm)
  • Foot placement estimator — baseline
    measure which estimates where the foot should be placed for stable gait
  • Onset latency — baseline
    latency in msec between onset of movements and activation recorded by surface EMG of bilateral m. Erector Spinae (trunk stabilization), m. Gluteus medius (hip strategy), m. Tibialis anterior and m. Soleus (ankle strategy)
  • Peak amplitude — baseline
    peak amplitude in microvolts of the surface EMG of bilateral m. Erector Spinae (trunk stabilization), m. Gluteus medius (hip strategy), m. Tibialis anterior and m. Soleus (ankle strategy)
  • Fixation duration — baseline
    Duration of fixation of the eyes on target, measured by the Hololens 2
  • Gain — baseline
    Accuracy of the fixation of the eyes on target as measured by the Hololens 2
  • Latency — baseline
    Latency in msec between the movement of the target and the movement of the eyes and the head when following the target as measured by the Hololens 2.
  • Fall characteristics — monthly during 12 months of follow-up
    Fall diaries provide information on occurrence and number of falls, activity preceding a fall, cause of fall, obtained injuries and potential care that was received.

Trial sites (1)

FacilityCityRegionStatus
University of Antwerp Antwerp Belgium Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06345625 on ClinicalTrials.gov ↗ ← All trials in Belgium