- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07253467
Load Dependent Modulation of Spinal Excitability: Linking H-Reflex Supression and Whole Body Vibration Induced Reflex Latency (SRML)
Study Overview
Detailed Description
Participants will engage in a structured set of experimental tasks designed to evaluate the effects of postural mechanical loading, and whole-body vibration.
The protocol includes four primary standing conditions:
Quiet bipedal stance,
Single-leg stance on the left side,
Bipedal stance during whole-body vibration (WBV), and
Single-leg stance on the left side during WBV.
During all WBV conditions, two vibration amplitudes-2.2 mm and 1.2 mm-will be applied sequentially to assess amplitude-dependent modulation of reflex responses.
Throughout each condition, H-reflex recordings from the soleus muscle will be collected to quantify changes in spinal reflex excitability under varying postural and vibratory loads. In addition to these measurements, vibration-induced reflex latency will be evaluated by delivering vibratory stimuli at multiple frequencies (30, 32, 34, and 36 Hz) within the same experimental protocol. This approach allows for a comprehensive analysis of how both posture and vibratory parameters influence neuromuscular reflex pathways.
The investigators conducted an a priori power analysis for a repeated-measures ANOVA (within-subjects design) to determine the required sample size. The analysis was based on a medium expected effect size, specified as partial eta squared (ηₚ²) = 0.06, which corresponds to an effect size of f = 0.25. The investigators set the alpha error probability at 0.05 and the desired statistical power (1-β) at 0.80. The design included one group with five repeated measurements, assuming a correlation of 0.70 among repeated measures. Under these conditions, the critical F value was 2.5652405, with 4 numerator degrees of freedom and 48 denominator degrees of freedom. The power analysis indicated that a total sample size of 13 participants is required. The required sample size was calculated using G*Power version 3.1.9.4 (Franz Faul, University of Kiel, Germany).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bahçelievler
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Istanbul, Bahçelievler, Turkey (Türkiye), 34158
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy adults between 25 and 50 years of age
- Individuals willing to participate and able to provide informed consent
- Individuals who can stand independently for at least 10 minutes
- Participants with no known neurological, orthopedic, or balance impairments
Exclusion Criteria:
- Individuals who can not tolerate WBV
- Individuals who can not tolerate electrical stimulation
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Healthy participants
Participants will complete a series of experimental tasks involving postural mechanical and vibrational loading.
The protocol consists of quiet standing on both feet, single-leg standing on the left side, standing during whole-body vibration (WBV), and single-leg standing on the left side during WBV.
Vibration amplitudes of 2.2 mm and 1.2 mm will be applied in each condition.
H-reflex measurements will be recorded from the soleus muscle throughout all tasks to evaluate alterations in spinal reflex excitability.
Vibration induced reflex latency will be also measured with different vibration frequencies (30-32-34-36) also measured in the same protocol.
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Whole Body Vibration (WBV) is a neuromuscular training modality in which patients stand, sit, or exercise on a platform that delivers mechanical oscillations (30-36 Hz, 1-2 mm amplitude).
While WBV is applied H-Reflex tests are done.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Whole Body Vibration induced reflex latency
Time Frame: Day 1 (single-session, during each experimental condition)
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WBV induced reflex latency will be measured
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Day 1 (single-session, during each experimental condition)
|
|
H-Reflex Size
Time Frame: Day 1 (single-session, during each experimental condition)
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Peak to peak amplitude of the H-Reflex will be measured
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Day 1 (single-session, during each experimental condition)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IstPRMTRH2A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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