The Effect of Training on Brain Activity During Postural Tasks in Older Adults

Sponsor
KU Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT04594148
Collaborator
(none)
43
1
2
4.2
10.2

Study Details

Study Description

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. Next to the wasp game, a mediolateral tracking task will be used to standardize weight-shifting speed to allow a comparison of fNIRS data during stable weight-shifting performance. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Weight-shift training
N/A

Detailed Description

For this study, 40 healthy older adults will be included. A previous fNIRS study done by the investigators (unpublished) revealed that our primary outcome, weight-shifting speed, improved from 0,0668 ± 0,0255 m/s to 0,0916 ± 0,0350 m/s. Based on Caljouw et al. (2016), the investigators expect a training effect size of 20%, resulting in a weight-shifting speed of 0.1094 ± 0,0418 m/s. Applying a power of 80% and alpha of 0.05 for a repeated measures ANOVA with a within-between interaction design (within: pre vs post; between: training vs control) the investigators calculated a total sample size of 40 participants (20 per group). Considering possible data exclusion due to fNIRS measurements, the collected fNIRS data will be monitored during recruitment, and more participants will be recruited if necessary.

Prior to training on day 1, participants will be screened for inclusion based on the Montreal Cognitive Assessment (MoCA). Other cognitive assessments include the Flanker (inhibition), Set-Shifting (shifting attention), and Benton Judgement of Line Orientation (visuospatial ability) test, which will be administered on day 2. The Falls Efficacy Scale International (FES-I), a sarcopenia questionnaire (SARC-F), and the Pittsburgh Sleep Quality Index (PSQI) will also be administered on day 2 to assess fear of falling, sarcopenia, and the quality of sleep of the night between day 1 and day 2 of the experiment, respectively.

For both weight-shifting assessment and training, the VR-based Wasp Game will be used. Before starting the Wasp Game, functional limits of stability (fLOS) will be assessed by asking the participant to move the Centre of Mass (CoM) as far as possible over its base of support in eight different directions by pushing a virtual bar away from the center position. Maximum CoM shifts will be calculated and used for personalized scaling of the Wasp Game. The Wasp Game was developed and piloted to meet the requirements for balance training for older people and can capture weight-shifting speed and accuracy as learning outcomes. In the Wasp Game, the player is in the middle of an area infested by wasps. By moving the CoM towards a pre-defined 80% of the fLOS, a water stream will come on to hit the wasp. The Wasp Game single-task (WASP-ST) involves hitting wasps in the mediolateral (ML) direction only. During the Wasp Game dual-task (WASP-DT), a serial subtraction task is added as the secondary task, whereby the red ball (representing the CoM) will change color from red to white and white to red within a random interval between 2-5 seconds. A starting number will appear on the screen for 1.5 seconds at the beginning of each trial. Every time the ball changes its color, subtractions have to be made in threes. Subjects will indicate the correct number afterward, so as not to disturb the fNIRS recording.

During training on day 1, participants will perform 10 blocks of 2.5 min weight-shifting within the WASP-ST. Before, after, and 24h after training, balance performance will be assessed with the Mini Balance Evaluation Systems Test (MiniBEST), and weight-shifting ability with the fLOS, the WASP-ST, and WASP-DT. During the WASP-ST and WASP-DT, oxygenated (HbO2) and deoxygenated hemoglobin (HHb) will be assessed simultaneously by means of functional Near-Infrared Spectroscopy (fNIRS). To be able to compare HbO2 and HHb levels relative to a baseline, both the WASP-ST and WASP-DT will be offered in a block design of 20 sec standing still and looking at a screen capture of the Wasp Game and 20 sec of weight-shifting within the Wasp Game, alternating in 10 trials. In addition, weight-shifting speed will be standardized by implementing a white ball that participants have to track in the ML direction, to be able to compare fNIRS data on similar behavioral performance. The same block design will be implemented for this task. Cortical regions assessed with fNIRS include the prefrontal cortex (PFC), frontal eye fields (FEF), premotor cortex (PMC), supplementary motor area (SMA), and supplementary sensory cortex (SSC). To ensure similar fNIRS recording on all test moments, only the optodes will be removed between pre and post-testing while the cap stays in place. Between post and retention testing, certain spots on the head (i.e. Cz) will be marked to guide cap placement on day 2. In a recent study, fNIRS was found to have adequate test-retest reliability.

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Triggering Motor Memory Consolidation in Healthy Aging: the Effects of Complex Practice on Brain Activity During Learning of Postural Tasks
Actual Study Start Date :
Feb 8, 2021
Actual Primary Completion Date :
Jun 16, 2021
Actual Study Completion Date :
Jun 16, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Weight-shift training

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
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.

No Intervention: Passive control

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)

Outcome Measures

Primary Outcome Measures

  1. Mediolateral weight-shifting speed [2 days]

    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.

Secondary Outcome Measures

  1. #wasps hit [2 days]

    Change in the number of wasps hit during the wasp game from directly before to directly after intervention, from directly before to 24h after intervention and from directly after to 24h after intervention.

  2. AP trajectory error [2 days]

    Change in the weight-shifting error from the ideal trajectory during the wasp game in the anterior-posterior direction from directly before to directly after intervention, from directly before to 24h after intervention and from directly after to 24h after intervention.

  3. AP target error [2 days]

    Change in the weight-shifting target error during the wasp game in the anterior-posterior direction from directly before to directly after intervention, from directly before to 24h after intervention and from directly after to 24h after intervention.

  4. AP tracking error [2 days]

    Change in the anterior-posterior deviation during the tracking task between the target to track and participants' center of mass from pre to post, from directly before to directly after intervention, from directly before to 24h after intervention and from directly after to 24h after intervention.

  5. ML tracking error [2 days]

    Change in the mediolateral deviation during the tracking task between the target to track and participants' center of mass from directly before to directly after intervention, from directly before to 24h after intervention and from directly after to 24h after intervention.

  6. %amplitude [2 days]

    Change in the maximum amplitude reached by the participant as a percentage of the maximum amplitude of the target to track during the tracking task, which will be set at 80% of individual stability limits, from directly before to directly after intervention, from directly before to 24h after intervention and from directly after to 24h after intervention.

  7. functional limits of stability (fLOS) [2 days]

    Change in the functional limits of stability in eight directions (anterior, anterior-right, right, posterior-right, posterior, posterior-left, left, anterior-right) from directly before to directly after intervention, from directly before to 24h after intervention and from directly after to 24h after intervention.

  8. Oxygenated hemoglobin [2 days]

    Change in oxygenated hemoglobin as measured with functional Near-Infrared Spectroscopy (fNIRS) in five brain regions (prefrontal cortex, frontal eye fields, premotor cortex, supplementary motor area, somatosensory cortex) from directly before to directly after intervention, from directly before to 24h after intervention and from directly after to 24h after intervention.

Other Outcome Measures

  1. Mini Balance Evaluation Systems Test [2 days]

    Change in total Mini Balance Evaluation Systems Test (MiniBEST) score from directly before to directly after intervention, from directly before to 24h after intervention and from directly after to 24h after intervention. The MiniBEST is scored on a scale from 0 to 28, where higher scores represent a better outcome.

  2. Deoxygenated hemoglobin [2 days]

    Change in oxygenated hemoglobin as measured with functional Near-Infrared Spectroscopy (fNIRS) in five brain regions (prefrontal cortex, frontal eye fields, premotor cortex, supplementary motor area, somatosensory cortex) from directly before to directly after intervention, from directly before to 24h after intervention and from directly after to 24h after intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Being able to independently stand upright > 5min
Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Rehabilitation Sciences KU Leuven Leuven Belgium

Sponsors and Collaborators

  • KU Leuven

Investigators

  • Principal Investigator: Alice Nieuwboer, PhD, KU Leuven

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Alice Nieuwboer, Full professor, KU Leuven
ClinicalTrials.gov Identifier:
NCT04594148
Other Study ID Numbers:
  • S62917
First Posted:
Oct 20, 2020
Last Update Posted:
Aug 10, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alice Nieuwboer, Full professor, KU Leuven

Study Results

No Results Posted as of Aug 10, 2021