Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT05602857

Conditions

Executive Functions

Postural Balance

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Accepted

Interventions

Balance Training

Music Training

Study Details

Brief summary:

This randomized controlled trial will investigate the hypothesis that since balance and executive functions (EFs) require a similar neural circuit and EFs are recruited when trying to maintain balance, that training balance might improve EFs as well as balance. There will be an active control condition (watching music videos) and a no-treatment condition. Children (18-12 years old) will be randomly assigned to one of these conditions for 12 weeks (36 per condition). The balance and music conditions will involve 15-min sessions 3x/week and a weekly check-in session with an investigator. Participants will be assessed pre-intervention, immediately post and 3-months post.

Conditions

Executive Functions

Postural Balance

Study ID

NCT05602857

Start date

Jan 25, 2023

Status verified date

May, 2024

Completion date

Dec 30, 2024

Anticipated

Primary completion date

Nov 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Accepted

Inclusion Criteria

• Children between 8 to 12 years old.

Exclusion Criteria:

  • Children not fluent in English
  • Children with performance over the 85th percentile at screening assessment of postural balance or EFs that it leaves little room for them to improve further.
  • Children taking any medication that might affect cognition (e.g., psychostimulants)
  • Children undergoing EF training, which might affect their performance on EF tests.
  • Children undergoing other targeted training to improve their balance (e.g., dance, yoga, tai chi, martial arts), which might affect their performance on balance tests.
  • Children with severe anxiety who might find the balance training anxiety-provoking.
  • Children unable to perform simple balance exercises because of a physical handicap, disability, or musculoskeletal injury.
  • Children with significant hearing loss or visual impairment even with correction.
  • Neither the child's parent/guardian nor other responsible person strong enough to catch the child should he or she start to fall would be available to spot the child during the weekly session in case the child is assigned to the BT intervention.

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Balance Training

Participants will follow a home-based BT intervention specifically designed by the investigators to improve postural control and balance in children. The BT program will consist of training sessions every other day (3 days a week) and a total of up to 45 minutes of balance exercises per week (15 minutes or less per session), addressing static balance (i.e., standing on one foot) and dynamic balance (i.e., balancing a book on your head while walking).

active comparator: Music Training

Participants will follow a home-based MT intervention designed to provide enjoyable experiences to the child participants. The sessions will occur every other day (3 days a week) for a total of up to 45 minutes per week (15 minutes or less per session) for 12 weeks. The MT program will consist of a different selection of music videos each week, including a mix of familiar and new tunes.

no intervention: Business as usual

Children assigned to this control group will follow their usual activities during the 12 weeks between initial assessment and the second assessment.

Interventions

Balance Training

The BT program has multiple difficulty levels, and each child will progress at an individual pace tailored to their balance skills. Training sessions will emphasize top-down control of balance and contain a combination of dynamic and static balance exercises. Children and their parents will receive written step-by-step instructions, with photos, verbal and/or video instructions on their private OneDrive folder.

To monitor compliance, whether the exercises were done properly, and evaluate a child's progress, the parent/guardian will film the sessions, and upload the video to OneDrive, so we can score the child's performance and provide them with a progress tracking chart.

Every child will be given the equipment needed to do the balance exercises: two wooden beams that will make a 12-foot balance beam, four small wooden cubes that will raise the balance beam 5 inches off the ground, a wobble board, a hopscotch mat, one roll of painter's tape, one measuring tape, a bell, a small book.

Music Training

Children assigned to MT will be asked what kind of music and what performers they like best, and what songs they like most. After those open-ended questions, they will be asked about specific songs, guided somewhat by the child's previous answers, and will watch short excerpts from music videos to see which the child would like to listen to and watch during Week 1 of the MT program. This is all to guide the selection of music videos the child will enjoy and might give some thought to.

They will receive 10 music videos per week, through the child's private OneDrive folder, from which they can choose 4 to watch every session. Children will be instructed to not do anything else, but simply watch the videos or listen with their eyes closed.

To monitor compliance, and to check if the child was paying attention to the music videos or just having them play in the background while doing something else, the parent/guardian will film the MT sessions, and upload the video to OneDrive.

Primary outcome measure

  • Change from baseline in Working Memory accuracy composite score [ Time Frame: Baseline and post-intervention (12 weeks) ]
  • Change from baseline in Inhibitory Control accuracy composite score [ Time Frame: Baseline and post-intervention (12 weeks) ]
  • Change from baseline in Cognitive Flexibility accuracy composite score [ Time Frame: Baseline and post-intervention (12 weeks) ]
  • Change from baseline in Planning / problem solving accuracy composite score [ Time Frame: Baseline and post-intervention (12 weeks) ]
  • Change from baseline in Sway-area Bipedal stance, eyes closed [ Time Frame: Baseline and post-intervention (12 weeks) ]
  • Change from baseline in Sway-area Bipedal stance, eyes open [ Time Frame: Baseline and post-intervention (12 weeks) ]
  • Change from baseline in Sway-area Tandem stance, eyes closed [ Time Frame: Baseline and post-intervention (12 weeks) ]
  • Change from baseline in Sway-area Tandem stance, eyes open [ Time Frame: Baseline and post-intervention (12 weeks) ]
  • Change from baseline in Sway-area Unipedal stance, eyes closed [ Time Frame: Baseline and post-intervention (12 weeks) ]
  • Change from baseline in Sway-area Unipedal stance, eyes open [ Time Frame: Baseline and post-intervention (12 weeks) ]
  • Change from baseline in time standing on a wobble board, eyes open [ Time Frame: Baseline and post-intervention (12 weeks) ]

Central Contacts and Locations

Central contacts

Priscilla Paz, MD

6046490702pspaz@student.ubc.ca

Locations

Developmental Cognitive Neuroscience Lab, Department of Psychiatry, UBC

Recruiting

Vancouver, British Columbia, Canada, V6T 2A1

Contacts

Adele Diamond, PhD

604.822.7220adele.diamond@ubc.ca

Priscilla Paz, MD

604.649.0702pspaz@student.ubc.ca

Principal Investigator:

Adele Diamond, PhD

More Information

Sponsor

University of British Columbia

Last update posted

May 10, 2024

Last verified

May, 2024

Keywords

  • executive functions
  • postural balance
  • balance training
  • music

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-05-10.