Effects of EMG-Biofeedback Balance Training on Hoffman's Reflex

NCT ID: NCT06418503

Last Updated: 2024-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2025-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Injuries caused by falls are a major worldwide issue and the most serious injuries include hip fractures and trauma to the brain. In-depth analysis of the risk factors for falls have discovered that balance disorders and abnormal gait are the strongest contributors. It is not a surprise that neural control of posture is altered as a function of age. Falls among the elderly has become an increasing issue and are leading to an escalating number of medical conditions, mortality and utilization of health care services. In Canada, 32 to 42% of older adults who are 70 years or older fall each year. Balance is the key ability needed to avoid falls because maintaining upright balance is needed to complete individual daily activities. Quantitative assessments are needed when evaluating the postural balance of participants. The force plate is a piece of equipment that is a reliable balance assessment method which is used widely in both laboratory and clinical settings. Despite the many research studies over the last three decades analyzing the effects of age and postural control, the number of deaths caused by falling and fall-related injuries has continued to increase. More studies are needed to highlight how old age affects neural mechanisms of postural control. Specifically, we need to understand the mechanisms by which balance training can lead to improved postural control to decrease falls among older adults.

A valuable neurophysiological measurement known as the Hoffman (H) reflex, has a high sensitivity to posture. Measuring the H-reflex amplitude can be used to detect whether changes in spinal excitability accompany balance training. It is a relatively simple technique which makes it an intriguing tool for research. The H-reflex has been used for decades in motor control studies which emphasize spinal mechanisms. It is commonly used as a tool for analyzing spinal excitability, or how effectively synaptic transmission occurs between motor neurons and 1a afferents.

For balance training, electromyography (EMG) biofeedback can be implemented which would involve the participants controlling objects on a screen through the electrical signals of their muscles while standing. The sensors used for EMG are not painful or invasive and can be applied to target the impairment of specific muscles or muscle groups. The EMG-Biofeedback system creates a classifier that predicts the user's intended game control inputs through real-time EMG signals. This innovation would be achieved by placing the sensors on the upper leg and arms to collect data for the signals of the lower and upper extremities, so the motor performance and successful game execution can be focused on the balance of participants. Eighteen sessions (40 minutes each) of EMG-biofeedback training of the lower body (tibialis anterior muscle) over three weeks in participants suffering with chronic stroke was shown to improve motor control outcomes including balance and strength.

To gain a further understanding of the neurophysiological effects of EMG-biofeedback, we will be analyzing changes in spinal reflex excitability by measuring H-reflex amplitudes, and balance board test results before and after 4 weeks of balance training in the aging population. While there have been published studies regarding this intervention improving balance, there have not been any studies exploring whether EMG-biofeedback training also changes spinal reflex excitability. This intervention has the potential to improve spinal reflexes and balance of older adults and prevent future falls. This intervention can possibly decrease major injuries across the healthy older adult population, and changes in H-reflex amplitudes can be associated with balance changes. Studies which have explored changes in H-reflex amplitude after one-month long balance training, have not done a follow-up assessment to confirm the longevity of improvements in balance and decreased amplitudes of the H-reflex.

Methods:

During the participants' first visit to the laboratory, they will complete 3 functional assessments, and one neurophysiological assessment. The functional assessments will measure balance in a standing position. These balance assessments will take approximately 10 min. to complete. The measurement of muscle activity will involve non-invasive stimulation behind the knee which will evoke a muscle twitch in the calve (soleus) muscle. This Hoffman Reflex assessment will be completed for each leg and reflects the activity of circuits within the spinal cord that are thought to contribute to balance. This procedure requires approximately 20 minutes for each leg.

The participants will be randomly assigned to the balance training or biofeedback balance training group by the lead investigator of this study, and the participant will not be told which group they have been assigned to. Irrespective of which group the participant has been assigned to, they will have electrodes placed on upper and lower body muscles which will be attached to the EMG system using leads and you will be completing a computer game that requires your balance for 30 min. each of your training sessions. Assistive devices such as canes, walkers etc. will not be used during the balance training. The participants can take breaks and sit down occasionally during the balance training. This training will take place 4 times per week for a total of 16 times. Both groups will experience the computer game during standing balance training.

The day after their last session, they will complete a follow-up assessment session which will also involve completion of the 3 functional balance tests and measurement of muscle activity for each leg, which will follow the same procedure as the first assessment session.

The second follow-up assessment will take place 2 weeks after the final training session. All assessments from the first follow-up will be repeated.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Reflex Excitability Balance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Participants will be masked to which intervention they receive (balance training or EMG-biofeedback balance training).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Balance Training

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

Group Type SHAM_COMPARATOR

Balance Training

Intervention Type OTHER

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

EMG-Biofeedback Training

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

Group Type EXPERIMENTAL

EMG-Biofeedback Training

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Balance Training

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

Intervention Type OTHER

EMG-Biofeedback Training

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

McMaster University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Aimee J Nelson, PhD

Role: CONTACT

9055259140 ext. 28053

Ava R Bobinski, BSc

Role: CONTACT

9059334648

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 33800119 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38185708 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30598705 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36571622 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36498431 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17485

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.