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

NCT06345625 | Recruiting

• 1 other identifier: 6012
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aged; Accidental Fall; Postural Balance; Gait

Keywords

older adults; Sensorimotor integration; visual tracking while walking

Outcome Measures

Primary Outcomes (8)

• Spatio-temporal parameters of gait

  step length and width (cm)

  baseline

• Foot placement estimator

  measure which estimates where the foot should be placed for stable gait

  baseline

• Onset latency

  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)

  baseline

• Peak amplitude

  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)

  baseline

• Fixation duration

  Duration of fixation of the eyes on target, measured by the Hololens 2

  baseline

• Gain

  Accuracy of the fixation of the eyes on target as measured by the Hololens 2

  baseline

• Latency

  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.

  baseline

• Fall characteristics

  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.

  monthly during 12 months of follow-up

Secondary Outcomes (10)

• Multisensory integration

  baseline

• Digit symbol substitution test

  baseline

• Trail making test

  baseline

• Go/No Go test

  baseline

• Head Repositioning Accuracy

  baseline

Other Outcomes (4)

• Age

  Screening before inclusion

• Gender

  Screening before inclusion

• Medical history

  Screening before inclusion

Study Arms (2)

Fallers

Community dwelling older adults with an age above 65 years. A participant is categorized as faller in case of a history of ≥2 falls in the previous 12 months and with identified high fall risk on the TUG (i.e., completion time ≥13.5 seconds). A fall is defined as an event that results in a person coming to rest inadvertently on the ground/floor/other lower level (WHO, 2021). Asyncopal fall, identified through the report of a loss of consciousness during the fall, has a different etiology and therefore will not be counted as a fall (Ang et al., 2020).

Diagnostic Test: Cognition; Diagnostic Test: Sensory function; Diagnostic Test: Frailty; Other: Biomechanical movement analysis; Other: Screening; Other: Follow up

Non-Fallers

Community dwelling older adults with an age above 65 years. A participant is included as non-faller in case of a history of 0 falls in the previous 12 months and without an identified fall risk on the TUG test (i.e., completion time ≤13.5 seconds).

Diagnostic Test: Cognition; Diagnostic Test: Sensory function; Diagnostic Test: Frailty; Other: Biomechanical movement analysis; Other: Screening; Other: Follow up

Interventions

Cognition DIAGNOSTIC_TEST

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.

Fallers; Non-Fallers

Sensory function DIAGNOSTIC_TEST

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.

Fallers; Non-Fallers

Frailty DIAGNOSTIC_TEST

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).

Fallers; Non-Fallers

Biomechanical movement analysis OTHER

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.

Fallers; Non-Fallers

Screening OTHER

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).

Fallers; Non-Fallers

Follow up OTHER

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.

Fallers; Non-Fallers

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community dwelling older adults with an age of 65 years or above

You may qualify if:

• Community dwelling
• an age of 65 years or above

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiteit Antwerpen: lead

Study Sites (1)

University of Antwerp

Antwerp, 2160, Belgium

RECRUITING

MeSH Terms

Interventions

Sensation; Mass Screening

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Ann Hallemans

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Hallemans, PhD

CONTACT

032652912; ann.hallemans@uantwerpen.be

Eugénie Lambrecht, MSc, PT

CONTACT

eugenie.lambrecht@uantwerpen.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: April 3, 2024
• Study Start: May 7, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

BE (1)