Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT07253467
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Load Dependent Modulation of Spinal Excitability: Linking H-Reflex Supression and Whole Body Vibration Induced Reflex Latency
Sponsor:
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Organization:
Study Overview
Official Title:
Load Dependent Modulation of Spinal Excitability: Linking H-Reflex Supression and Whole Body Vibration Induced Reflex Latency
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SRML
Brief Summary:
This study examines how different standing postures and whole-body vibration conditions affect spinal reflex activity. Participants will stand in various positions-with and without vibration of two amplitudes-and H-reflex responses from the soleus muscle will be recorded. Additionally, vibration-induced reflex latency will be assessed across multiple vibration frequencies.
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: