NCT04594148

Brief Summary

Older people show deficits in dynamic weight-shifting, as the investigators found that more time is needed to perform weight-shifts and the movements became less fluent and accurate in older versus younger adults. Deficits with weight-shifting in the mediolateral (left-right) direction have been linked to balance and falls in ageing. Balance control can be improved with training. Virtual reality (VR) based training programs for improving balance are gaining ground, as it can provide both fun and challenging balance tasks, enhancing motivation. The investigators demonstrated earlier that older adults show an overloaded neural activation pattern compared to young adults when performing the same VR-based mediolateral weight-shifting task (wasp game). What is yet unclear, is whether improved balance capacity can be gained with training and whether such an intervention impacts the underlying neural mechanisms. Using a combination of behavioral assessments and functional Near-Infrared Spectrocopy (fNIRS), the primary aim of this study is to investigate the effects of a VR-based weight-shift training and its underlying neural imprint in older adults. Furthermore, as a previous study done by the investigators also showed that adding an extra cognitive task in a so-called dual-task (DT) negatively affects weight-shifting performance, a secondary aim will be to test whether weight-shift training will enhance performance during such DT conditions. The results of this study may contribute to the future design of technology-based rehabilitation programs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

February 8, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2021

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

October 6, 2020

Last Update Submit

October 17, 2022

Conditions

Keywords

AgeingMotor learningPostural controlfNIRSDual-taskingWeight-shifting

Outcome Measures

Primary Outcomes (1)

  • Mediolateral weight-shifting speed

    Change in weight-shifting speed during the wasp game in the mediolateral direction from directly before to directly after intervention, from directly before to 24h after intervention and from directly after to 24h after intervention. As weight-shifting tends to slow down when reaching the 80% stability limit to aim for the wasp, mediolateral weight-shifting speed will be determined between 90% of the 80% stability limit on the right side to 90% of the 80% stability limit on the left side and vice versa.

    2 days

Secondary Outcomes (4)

  • #wasps hit

    2 days

  • AP trajectory error

    2 days

  • functional limits of stability (fLOS)

    2 days

  • Oxygenated hemoglobin

    2 days

Other Outcomes (2)

  • Mini Balance Evaluation Systems Test

    2 days

  • Deoxygenated hemoglobin

    2 days

Study Arms (2)

Weight-shift training

EXPERIMENTAL

The experimental group will receive a single session of 10x 2.5min of weight-shift training with the VR Wasp Game

Behavioral: Weight-shift training

Passive control

NO INTERVENTION

The passive control group will not receive any form of training. Instead, they will relax for 25min (i.e. talking with the researcher and/or reading a magazine)

Interventions

Weight-shift training will consist of a single session of 10x 2.5min of mediolateral weight-shifting in the VR Wasp Game. Including breaks, the session will approximately take 45min.

Weight-shift training

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Being able to independently stand upright \> 5min

You may not qualify if:

  • Visual impairment precluding following the targets on the screen
  • Cognitive impairment (MoCA\<24/26?) / (MMSE\<24)?
  • History of neurological disorders
  • Balance impairments (i.e. vestibular disorders)
  • Chronic musculoskeletal, cardiovascular and respiratory conditions
  • Diabetes related polyneuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation Sciences KU Leuven

Leuven, Belgium

Location

Related Publications (2)

  • Caljouw SR, Veldkamp R, Lamoth CJ. Implicit and Explicit Learning of a Sequential Postural Weight-Shifting Task in Young and Older Adults. Front Psychol. 2016 May 24;7:733. doi: 10.3389/fpsyg.2016.00733. eCollection 2016.

    PMID: 27252670BACKGROUND
  • Willaert J, De Vries AW, Tavernier J, Van Dieen JH, Jonkers I, Verschueren S. Does a novel exergame challenge balance and activate muscles more than existing off-the-shelf exergames? J Neuroeng Rehabil. 2020 Jan 15;17(1):6. doi: 10.1186/s12984-019-0628-3.

    PMID: 31941518BACKGROUND

Study Officials

  • Alice Nieuwboer, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 20, 2020

Study Start

February 8, 2021

Primary Completion

June 16, 2021

Study Completion

June 16, 2021

Last Updated

October 19, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations