NCT06418503

Brief Summary

The purpose of this study is to gain a further understanding of the effects of EMG-biofeedback balance training and we will be analyzing changes in spinal reflex excitability by responses from the calve muscles and data about your standing balance. The EMG-biofeedback balance training has the potential to improve balance of older adults and prevent future falls and in this study we will learn if it also creates changes in the nervous system. This study aims to 1) determine the effects of a one-month long EMG-biofeedback balance intervention on the H-reflex amplitude, 2) determine whether there is a related behavioural change in the control of balance and 3) determine whether changes in balance and H-reflex amplitude persist for up to two weeks following the end of the balance training intervention.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

May 13, 2024

Last Update Submit

May 21, 2024

Conditions

Keywords

Hoffman'sReflexBiofeedbackEMG

Outcome Measures

Primary Outcomes (2)

  • Change in Spinal Reflex Excitability

    Measurements of maximal Hoffman reflex

    Pre-intervention (before 1st training session), post-intervention (1-2 days after last training session), 2-week follow-up

  • Change in Balance

    Measurements of balance using balance board assessments

    Pre-intervention (before 1st training session), post-intervention (1-2 days after last training session), 2-week follow-up

Study Arms (2)

Balance Training

SHAM COMPARATOR

Completing a Tetris (block stacking) computer game while attached to an EMG device by electrodes and leads.

Other: Balance Training

EMG-Biofeedback Training

EXPERIMENTAL

Completing an EMG-biofeedback block stacking game using the electrodes to detect muscle signals which are controlling the movements of the blocks.

Other: EMG-Biofeedback Training

Interventions

Participants will complete 16 sessions of balance training (30 min. each) over one month.

Balance Training

Participants will complete 16 sessions of EMG-biofeedback balance training (30 min. each) over one month.

EMG-Biofeedback Training

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy older adults between 60-75 years old
  • able to stand free of assistive devices for at least 3 consecutive minutes
  • free of visual disorders that prevent meaningful interaction with the intervention interface.

You may not qualify if:

  • Sustained a serious musculoskeletal injury in the past 6 months or have any diagnosis that could impact movement coordination or balance
  • significant cognitive or language barriers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Chen B, Liu P, Xiao F, Liu Z, Wang Y. Review of the Upright Balance Assessment Based on the Force Plate. Int J Environ Res Public Health. 2021 Mar 8;18(5):2696. doi: 10.3390/ijerph18052696.

    PMID: 33800119BACKGROUND
  • Bakker LBM, Lamoth CJC, Vetrovsky T, Gruber M, Caljouw SR, Nieboer W, Taube W, van Dieen JH, Granacher U, Hortobagyi T. Neural Correlates of Balance Skill Learning in Young and Older Individuals: A Systematic Review and Meta-analysis. Sports Med Open. 2024 Jan 7;10(1):3. doi: 10.1186/s40798-023-00668-3.

    PMID: 38185708BACKGROUND
  • Tsaih PL, Chiu MJ, Luh JJ, Yang YR, Lin JJ, Hu MH. Practice Variability Combined with Task-Oriented Electromyographic Biofeedback Enhances Strength and Balance in People with Chronic Stroke. Behav Neurol. 2018 Nov 26;2018:7080218. doi: 10.1155/2018/7080218. eCollection 2018.

    PMID: 30598705BACKGROUND
  • Theodosiadou A, Henry M, Duchateau J, Baudry S. Revisiting the use of Hoffmann reflex in motor control research on humans. Eur J Appl Physiol. 2023 Apr;123(4):695-710. doi: 10.1007/s00421-022-05119-7. Epub 2022 Dec 26.

    PMID: 36571622BACKGROUND
  • Park C, Mishra RK, York MK, Enriquez A, Lindsay A, Barchard G, Vaziri A, Najafi B. Tele-Medicine Based and Self-Administered Interactive Exercise Program (Tele-Exergame) to Improve Cognition in Older Adults with Mild Cognitive Impairment or Dementia: A Feasibility, Acceptability, and Proof-of-Concept Study. Int J Environ Res Public Health. 2022 Dec 6;19(23):16361. doi: 10.3390/ijerph192316361.

    PMID: 36498431BACKGROUND
  • Public Health Agency of Canada. (2022). Senior-falls-in-Canada-en.pdf. Surveillance Report on Falls Among Older Adults in Canada. https://www.canada.ca/content/dam/hc-sc/documents/reserch/surveillance/senior-falls-in-Canada-en.pdf

    BACKGROUND

Central Study Contacts

Aimee J Nelson, PhD

CONTACT

Ava R Bobinski, BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be masked to which intervention they receive (balance training or EMG-biofeedback balance training).
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2024

First Posted

May 17, 2024

Study Start

July 1, 2024

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

May 22, 2024

Record last verified: 2024-05