H-reflexBMR-HREFNCT07043595
H-Reflex Suppression by Bone Myoregulation Reflex During Mechanical Loading in Standing Humans
A study testing Whole-Body Vibration (WBV) in people with H-reflex and Spinal Reflexes, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate how standing posture and mechanical loading affect reflex responses in the lower limb. Specifically, it focuses on the H-reflex-a type of spinal cord reflex-and how it changes during quiet standing and whole-body vibration. Ten healthy adult volunteers will participate. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- H-reflex, Spinal Reflexes, Posture
- What is being tested?
- Whole-Body Vibration (WBV)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jun 2025to 10 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 20 to 45 years
- Able to stand independently for at least 10 minutes
- No known neurological, orthopedic, or balance disorders
- Willingness to participate and provide informed consent
Who cannot join
- History of spinal cord injury, peripheral neuropathy, or muscle disease
- Recent lower limb surgery or musculoskeletal trauma
- Current use of medications affecting neuromuscular function
- Pregnancy
- Any contraindications to exposure to mechanical vibration
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
Istanbul, Istanbul
About this study
Official title: Neuronal Mechanisms Underlying H-Reflex Suppression During Mechanical Loading: The Role of Bone Myoregulation Reflex in Standing Humans
This study aims to investigate how standing posture and mechanical loading affect reflex responses in the lower limb. Specifically, it focuses on the H-reflex-a type of spinal cord reflex-and how it changes during quiet standing and whole-body vibration. Ten healthy adult volunteers will participate. Researchers will record electrical responses from the calf muscle (soleus) while participants stand still or are exposed to gentle vibration. The goal is to better understand how the nervous system and skeletal system interact in regulating balance and movement.
Read the detailed description
This study investigates the neural mechanisms responsible for suppression of the H-reflex-a spinal monosynaptic reflex-during mechanical loading in the standing position. Previous research has shown that H-reflex amplitude decreases with increasing postural demand, such as during walking or standing compared to lying down. One hypothesis suggests that this suppression may be mediated not only by vestibular and cutaneous afferents, but also by a bone-derived reflex mechanism called the Bone Myoregulation Reflex (BMR).
In this study, 10 healthy adult volunteers will undergo H-reflex measurements while standing in various loading conditions, including quiet standing and during whole-body vibration (WBV). Participants will stand with one foot isolated from vibration while the other foot is on a vibrating platform. H-reflexes will be recorded from the soleus muscle using standard surface electromyography.
The primary aim is to determine whether BMR contributes to H-reflex suppression during loading. The findings may provide insight into the interaction between skeletal loading and spinal reflex modulation, with potential relevance to balance, gait, and rehabilitation science.
- Conditions
- H-reflex, Spinal Reflexes, Posture, Weight-Bearing, Neuromuscular Physiology
- Being tested
- Whole-Body Vibration (WBV)
- Keywords
- Bone Myoregulation Reflex, Whole-Body Vibration, Electrophysiology, Soleus Muscle, Presynaptic Inhibition, Mechanoreceptors, Reflex Suppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-Body Vibration (WBV)Procedure or surgery
Also called WBV
Participants will stand quietly in an upright position while whole-body vibration (WBV) is applied through a vibration platform. The vibration stimulus is delivered while the participant's left foot remains on the vibration surface and the right foot is elevated or isolated. H-reflex recordings are taken from the soleus muscle during the procedure to assess spinal reflex modulation due to mechanical loading.
| Study group | Role | What they receive |
|---|---|---|
| Postural Loading and Vibration Arm | Experimental | Participants in this arm will undergo a sequence of experimental conditions involving postural and mechanical loading. The protocol includes standing quietly on both feet, standing on one foot (right or left), and standing during whole-body vibration (WBV). H-reflex recordings will be obtained from the soleus muscle during each condition to assess changes in spinal reflex excitability. Receives: Procedure: Whole-Body Vibration (WBV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
H-reflex Amplitude
The amplitude of the H-reflex recorded from the soleus muscle, evoked at 15% Mmax stimulation level, will be measured during each condition (quiet standing, one-leg stance, and whole-body vibration). The primary aim is to assess changes in spinal excitability due to mechanical loading.
Measured: Day 1 (single-session, during each experimental condition)
Secondary outcomes (1)
Background EMG Activity
Background electromyographic activity of the soleus muscle will be evaluated over a 450 ms window prior to stimulation to ensure muscle quiescence and verify that changes in reflex amplitude are not due to background activity.
Measured: Day 1 (450 ms window prior to stimulation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start24 Jun 2025
- Primary completion7 Jul 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for H-reflexStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group crossover design in which each participant undergoes all experimental conditions in a fixed order, including quiet standing, weight-shifting, and whole-body vibration. Electrophysiological recordings are obtained during each condition.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Selim Sezikli, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- Selim Sezikli, MD, Principal investigator, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043595
- Sponsor's protocol ID
- HReflexBMR2025
- Acronym
- BMR-HREF
- Status last verified
- Aug 2025
- First submitted
- 22 Jun 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the small sample size and the nature of the study, which focuses on basic physiological measurements in healthy volunteers. No data repository is currently planned.
Publications
Ozkan IA, Alayoglu FO, Kalaoglu E, Dogan N, Yildiz N, Yurtseven M, Ones K, Karacan I, Turker KS. Load-dependent dissociation between H-reflex amplitude and background EMG activity during oscillatory loading: implications for the bone myoregulation reflex. Exp Brain Res. 2026 Jul 9;244(8):154. doi: 10.1007/s00221-026-07349-z.
PubMed 42423762
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuronal Mechanisms Underlying H-Reflex Suppression During Mechanical Loading: The Role of Bone Myoregulation Reflex in Standing Humans
- ClinicalTrials.gov ID
- NCT07043595
- Acronym / sponsor ID
- BMR-HREF / HReflexBMR2025
- Conditions
- H-reflex, Spinal Reflexes, Posture, Weight-Bearing, Neuromuscular Physiology
- Keywords
- Bone Myoregulation Reflex, Whole-Body Vibration, Electrophysiology, Soleus Muscle, Presynaptic Inhibition, Mechanoreceptors, Reflex Suppression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 29 Jun 2025 (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.
This study aims to investigate how standing posture and mechanical loading affect reflex responses in the lower limb. Specifically, it focuses on the H-reflex-a type of spinal cord reflex-and how it changes during quiet standing and whole-body vibration. Ten healthy adult volunteers will participate. Researchers will record electrical responses from the calf muscle (soleus) while participants stand still or are exposed to gentle vibration. The goal is to better understand how the nervous system and skeletal system interact in regulating balance and movement.
Detailed description
This study investigates the neural mechanisms responsible for suppression of the H-reflex-a spinal monosynaptic reflex-during mechanical loading in the standing position. Previous research has shown that H-reflex amplitude decreases with increasing postural demand, such as during walking or standing compared to lying down. One hypothesis suggests that this suppression may be mediated not only by vestibular and cutaneous afferents, but also by a bone-derived reflex mechanism called the Bone Myoregulation Reflex (BMR).
In this study, 10 healthy adult volunteers will undergo H-reflex measurements while standing in various loading conditions, including quiet standing and during whole-body vibration (WBV). Participants will stand with one foot isolated from vibration while the other foot is on a vibrating platform. H-reflexes will be recorded from the soleus muscle using standard surface electromyography.
The primary aim is to determine whether BMR contributes to H-reflex suppression during loading. The findings may provide insight into the interaction between skeletal loading and spinal reflex modulation, with potential relevance to balance, gait, and rehabilitation science.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group crossover design in which each participant undergoes all experimental conditions in a fixed order, including quiet standing, weight-shifting, and whole-body vibration. Electrophysiological recordings are obtained during each condition.
| Arm | Type | Receives |
|---|---|---|
| Postural Loading and Vibration Arm | Experimental | Procedure: Whole-Body Vibration (WBV)Participants in this arm will undergo a sequence of experimental conditions involving postural and mechanical loading. The protocol includes standing quietly on both feet, standing on one foot (right or left), and standing during whole-body vibration (WBV). H-reflex recordings will be obtained from the soleus muscle during each condition to assess changes in spinal reflex excitability. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults aged 20 to 45 years
- Able to stand independently for at least 10 minutes
- No known neurological, orthopedic, or balance disorders
- Willingness to participate and provide informed consent
Key exclusion criteria (5 listed)
- History of spinal cord injury, peripheral neuropathy, or muscle disease
- Recent lower limb surgery or musculoskeletal trauma
- Current use of medications affecting neuromuscular function
- Pregnancy
- Any contraindications to exposure to mechanical vibration
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 |
|---|---|---|
| Whole-Body Vibration (WBV)Also: WBVParticipants will stand quietly in an upright position while whole-body vibration (WBV) is applied through a vibration platform. The vibration stimulus is delivered while the participant's left foot remains on the vibration surface and the right foot is elevated or isolated. H-reflex recordings are taken from the soleus muscle during the procedure to assess spinal reflex modulation due to mechanical loading. | Procedure or surgery | Postural Loading and Vibration Arm |
Primary outcome
H-reflex Amplitude
Time frame: Day 1 (single-session, during each experimental condition)
The amplitude of the H-reflex recorded from the soleus muscle, evoked at 15% Mmax stimulation level, will be measured during each condition (quiet standing, one-leg stance, and whole-body vibration). The primary aim is to assess changes in spinal excitability due to mechanical loading.
1 secondary outcome
Background EMG Activity
Time frame: Day 1 (450 ms window prior to stimulation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Derived from this study: PubMed 42423762Ozkan IA, Alayoglu FO, Kalaoglu E, Dogan N, Yildiz N, Yurtseven M, Ones K, Karacan I, Turker KS. Load-dependent dissociation between H-reflex amplitude and background EMG activity during oscillatory loading: implications for the bone myoregulation reflex. Exp Brain Res. 2026 Jul 9;244(8):154. doi: 10.1007/s00221-026-07349-z.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the small sample size and the nature of the study, which focuses on basic physiological measurements in healthy volunteers. No data repository is currently planned.
Related trials for H-reflex
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Effect of TENS on Spasticity
Post Stroke Spasticity
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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.
Selim Sezikli, MD principal investigator
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-Body Vibration (WBV) in people with H-reflex and Spinal Reflexes, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H-reflex Amplitude (time frame: Day 1 (single-session, during each experimental condition)). 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 NCT07043595, which also lists 1 linked publication.
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 4 Sep 2025.