NCT07043595

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

June 24, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2025

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

13 days

First QC Date

June 22, 2025

Last Update Submit

August 28, 2025

Conditions

Keywords

Bone Myoregulation ReflexWhole-Body VibrationElectrophysiologySoleus MusclePresynaptic InhibitionMechanoreceptorsReflex Suppression

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1 (single-session, during each experimental condition)

Secondary Outcomes (1)

  • Background EMG Activity

    Day 1 (450 ms window prior to stimulation)

Study Arms (1)

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.

Procedure: Whole-Body Vibration (WBV)

Interventions

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.

Also known as: WBV
Postural Loading and Vibration Arm

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Location

Study Officials

  • Selim Sezikli, MD

    Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

June 22, 2025

First Posted

June 29, 2025

Study Start

June 24, 2025

Primary Completion

July 7, 2025

Study Completion

July 10, 2025

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

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.

Locations