Spinal Reflex ExcitabilityNCT06418503
Effects of EMG-Biofeedback Balance Training on Hoffman's Reflex
A study testing Balance Training and EMG-Biofeedback Training in people with Spinal Reflex Excitability and Balance, run by McMaster University.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Reflex Excitability, Balance
- What is being tested?
- Balance Training and EMG-Biofeedback Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of EMG-Biofeedback Balance Training on Hoffman's Reflex and Their Longevity
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.
Read the detailed description
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
- Spinal Reflex Excitability, Balance
- Being tested
- Balance Training, EMG-Biofeedback Training
- Keywords
- Hoffman's, Reflex, Biofeedback, EMG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance TrainingOther
Participants will complete 16 sessions of balance training (30 min. each) over one month.
EMG-Biofeedback TrainingOther
Participants will complete 16 sessions of EMG-biofeedback balance training (30 min. each) over one month.
| Study group | Role | What they receive |
|---|---|---|
| Balance Training | Sham comparator | Completing a Tetris (block stacking) computer game while attached to an EMG device by electrodes and leads. Receives: 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. Receives: Other: EMG-Biofeedback Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spinal Reflex Excitability
Measurements of maximal Hoffman reflex
Measured: 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
Measured: Pre-intervention (before 1st training session), post-intervention (1-2 days after last training session), 2-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spinal Reflex ExcitabilityStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418503
- Sponsor's protocol ID
- 17485
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33800119Bakker 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.
PubMed 38185708Tsaih 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.
PubMed 30598705Theodosiadou 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.
PubMed 36571622Park 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.
PubMed 36498431Public 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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of EMG-Biofeedback Balance Training on Hoffman's Reflex and Their Longevity
- ClinicalTrials.gov ID
- NCT06418503
- Acronym / sponsor ID
- 17485
- Conditions
- Spinal Reflex Excitability, Balance
- Keywords
- Hoffman's, Reflex, Biofeedback, EMG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance Training | Sham comparator | Other: Balance TrainingCompleting a Tetris (block stacking) computer game while attached to an EMG device by electrodes and leads. |
| EMG-Biofeedback Training | Experimental | Other: EMG-Biofeedback TrainingCompleting an EMG-biofeedback block stacking game using the electrodes to detect muscle signals which are controlling the movements of the blocks. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance TrainingParticipants will complete 16 sessions of balance training (30 min. each) over one month. | Other | Balance Training |
| EMG-Biofeedback TrainingParticipants will complete 16 sessions of EMG-biofeedback balance training (30 min. each) over one month. | Other | EMG-Biofeedback Training |
Primary outcome
Change in Spinal Reflex Excitability
Time frame: Pre-intervention (before 1st training session), post-intervention (1-2 days after last training session), 2-week follow-up
Measurements of maximal Hoffman reflex
Change in Balance
Time frame: Pre-intervention (before 1st training session), post-intervention (1-2 days after last training session), 2-week follow-up
Measurements of balance using balance board assessments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Background: PubMed 33800119Chen 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.
- Background: PubMed 38185708Bakker 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.
- Background: PubMed 30598705Tsaih 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.
- Background: PubMed 36571622Theodosiadou 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.
- Background: PubMed 36498431Park 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.
- BackgroundPublic 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Balance Training and EMG-Biofeedback Training in people with Spinal Reflex Excitability and Balance, run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aimee J Nelson, PhD (9055259140 ext. 28053, nelsonaj@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Spinal Reflex Excitability (time frame: Pre-intervention (before 1st training session), post-intervention (1-2 days after last training session), 2-week follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06418503, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.