Can Training Balance, or Enjoying Music, Improve Attention, Problem-solving and/or Behavior Control Abilities?

NCT05602857 | Recruiting

• 1 other identifier: Balance and EFs study
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Keywords

executive functions; postural balance; balance training; music

Outcome Measures

Primary Outcomes (11)

• Change from baseline in Working Memory accuracy composite score

  Scores for accuracy (percentage of correct responses) from each individual EF test will be analyzed separately and, using z scores, will be combined into a composite score for WM. EF tests included N-back, Re-ordering digits, hearts and flowers, flanker/reverse flanker, street test, farmer Joe, tower of London and design fluency test

  Baseline and post-intervention (12 weeks)

• Change from baseline in Inhibitory Control accuracy composite score

  Scores for accuracy (percentage of correct responses) from each individual EF test will be analyzed separately and, using z scores, will be combined into a composite score for IC. EF tests included N-back, Re-ordering digits, hearts and flowers, flanker/reverse flanker, street test, farmer Joe, tower of London and design fluency test

  Baseline and post-intervention (12 weeks)

• Change from baseline in Cognitive Flexibility accuracy composite score

  Scores for accuracy (percentage of correct responses) from each EF test will be analyzed separately and, using z scores, will be combined into a composite score for CF, and planning/problem-solving. EF tests included N-back, Re-ordering digits, hearts and flowers, flanker/reverse flanker, street test, farmer Joe, tower of London and design fluency test

  Baseline and post-intervention (12 weeks)

• Change from baseline in Planning / problem solving accuracy composite score

  Scores for accuracy (percentage of correct responses) from each EF test will be analyzed separately and, using z scores, will be combined into a composite score for planning/problem-solving. EF tests included N-back, Re-ordering digits, hearts and flowers, flanker/reverse flanker, street test, farmer Joe, tower of London and design fluency test

  Baseline and post-intervention (12 weeks)

• Change from baseline in Sway-area Bipedal stance, eyes closed

  measure os postural sway (displacements in the center of pressure (COP)) in millimetres on static bipedal stance (feet shoulder width apart) with eyes closed

  Baseline and post-intervention (12 weeks)

• Change from baseline in Sway-area Bipedal stance, eyes open

  measure postural sway (displacements in the center of pressure (COP)) in millimetres on static bipedal stance (feet shoulder width apart) with eyes open

  Baseline and post-intervention (12 weeks)

• Change from baseline in Sway-area Tandem stance, eyes closed

  measure postural sway (displacements in the center of pressure (COP)) in millimetres on static Tandem stance with eyes closed

  Baseline and post-intervention (12 weeks)

• Change from baseline in Sway-area Tandem stance, eyes open

  measure postural sway (displacements in the center of pressure (COP)) in millimetres on static Tandem stance with eyes open

  Baseline and post-intervention (12 weeks)

• Change from baseline in Sway-area Unipedal stance, eyes closed

  measure postural sway (displacements in the center of pressure (COP)) in millimetres on static Unipedal stance with eyes closed

  Baseline and post-intervention (12 weeks)

• Change from baseline in Sway-area Unipedal stance, eyes open

  measure postural sway (displacements in the center of pressure (COP)) in millimetres on static Unipedal stance with eyes open

  Baseline and post-intervention (12 weeks)

• Change from baseline in time standing on a wobble board, eyes open

  measure the maximum time participants can maintain their balance standing on a wobble board with their eyes open.

  Baseline and post-intervention (12 weeks)

Secondary Outcomes (11)

• Change from baseline in Working Memory accuracy composite score

  Baseline and 3 months post-intervention

• Change from baseline in Planning / problem solving accuracy composite score

  Baseline and 3 months post-intervention

• Change from baseline in Inhibitory Control accuracy composite score

  Baseline and 3 months post-intervention

• Change from baseline in Cognitive Flexibility accuracy composite score

  Baseline and 3 months post-intervention

• Change from baseline in Sway-area Bipedal stance, eyes closed

  Baseline and 3 months post-intervention

Study Arms (3)

Balance Training

EXPERIMENTAL

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).

Other: Balance Training

Music Training

ACTIVE COMPARATOR

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.

Other: Music Training

Business as usual

NO INTERVENTION

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 OTHER

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.

Also known as: Balance exercises

Balance Training

Music Training OTHER

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.

Also known as: enjoying music videos

Music Training

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children between 8 to 12 years old.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Natural Sciences and Engineering Research Council, Canada: collaborator

Study Sites (1)

Developmental Cognitive Neuroscience Lab, Department of Psychiatry, UBC

Vancouver, British Columbia, V6T 2A1, Canada

RECRUITING

Study Officials

• Adele Diamond, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Priscilla Paz, MD

CONTACT

6046490702; pspaz@student.ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single-blinded randomized controlled trial. Participants will be blinded, that is, they will not know whether we expect more EF benefit from the balance training or music condition. During recruitment we will tell the families that we are investigating whether either Balance Training (BT) and/or Music Training (MT) can improve EFs, and that we have reasons to believe that both interventions can do so. Assessment of outcomes will not be blinded, however, because the investigator (Dr. Priscilla Paz) responsible for monitoring the interventions will also be conducting the assessments.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor and head of the Developmental Cognitive Neuroscience program

Model Details: Participants will be randomly allocated to one of 3 groups: Balance Training, Music Training, and business as usual (control). All groups will receive assessment of EFs and balance upon their entry into the study, 12 weeks later, and 3 months after that.

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 2, 2022
• Study Start: January 25, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)