NCT07439705

Brief Summary

Previous studies have shown that stimulation of heel skin mechanoreceptors facilitates the soleus H-reflex, whereas stimulation of metatarsal region mechanoreceptors inhibits the soleus H-reflex. From this perspective, plantar cutaneous receptors may play an important role in the regulation of activities such as walking and running, as well as in the control of spasticity in patients with upper motor neuron lesions. Investigating the effect of heel skin mechanoreceptors on plantar flexor muscle contraction force may provide valuable insight into the potential influence of these mechanoreceptors on locomotor activities and muscle tone, and may offer a foundation for future studies directly addressing these topics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 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

Study Start

First participant enrolled

September 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 23, 2026

Last Update Submit

February 26, 2026

Conditions

Keywords

Skin mechanoreceptorRuffini corpusclePacinian corpuscleContraction forcee

Outcome Measures

Primary Outcomes (3)

  • Voluntary Contraction Force

    While the participants were lying prone on the examination table, plantar flexion muscle strength was assessed using a computer-connected force sensor (SPIKE 2.7). For detailed analysis of the participant data using the SPIKE 2.7 force sensor software, an IIR digital filtering process was first applied to the force channel. During this procedure, a low-pass filter was selected. The filter settings were configured with a cutoff value of 100 and an order of 2. As a result of this filtering process, the newly generated filtered memory channel was labeled "ForceLP." Subsequently, the waveform average of the ForceLP channel was calculated with the following settings: width 4 s, offset 2 s, and trigger set to 6 stimuli (event+). From these averaged traces peak contraction force was determined.

    Day 1 (During a single experimental session)

  • Reflex Contraction Force

    While the participants were lying prone on the examination table, plantar flexion muscle strength was assessed using a computer-connected force sensor (SPIKE 2.7). For detailed analysis of the participant data using the SPIKE 2.7 force sensor software, an IIR digital filtering process was first applied to the force channel. During this procedure, a low-pass filter was selected. The filter settings were configured with a cutoff value of 100 and an order of 2. As a result of this filtering process, the newly generated filtered memory channel was labeled "ForceLP." Subsequently, the waveform average of the ForceLP channel was calculated with the following settings: width 4 s, offset 2 s, and trigger set to 6 stimuli (event+). From these averaged traces reflex contraction force was determined.

    Day 1 (During a single experimental session)

  • Reflex Contraction Latency

    While the participants were lying prone on the examination table, plantar flexion muscle strength was assessed using a computer-connected force sensor (SPIKE 2.7). For detailed analysis of the participant data using the SPIKE 2.7 force sensor software, an IIR digital filtering process was first applied to the force channel. During this procedure, a low-pass filter was selected. The filter settings were configured with a cutoff value of 100 and an order of 2. As a result of this filtering process, the newly generated filtered memory channel was labeled "ForceLP." Subsequently, the waveform average of the ForceLP channel was calculated with the following settings: width 4 s, offset 2 s, and trigger set to 6 stimuli (event+). From these averaged traces reflex contraction latency was determined.

    Day 1 (During a single experimental session)

Study Arms (1)

Prone position

EXPERIMENTAL

Plantar flexor muscle strength is assessed in the supine position. For the measurement of isometric muscle strength, participants lay prone on an examination table and were instructed to perform maximal plantar flexion for 10 seconds. To achieve a submaximal contraction corresponding to 15% of their maximal voluntary contraction, participants were asked to follow a 15% threshold reference line displayed on the force channel monitor.

Other: Assesment of Plantar Flexion Muscle Strength During Heel Skin Mechanoreceptor Stimulation

Interventions

For the measurement of isometric muscle strength, participants lying prone on an examination table were instructed to perform maximal plantar flexion for 10 seconds. To achieve a submaximal contraction corresponding to 15% of their maximal contraction force, they were asked to follow the 15% threshold reference line displayed on the force channel on the screen. During the measurement of plantar flexion muscle strength, the cutaneous mechanoreceptors of the heel were stimulated with a square-wave electrical current with a pulse duration of 1 microsecond, at an intensity three times the sensory threshold. Electrical stimulation was delivered via a constant-current stimulator (Digitimer DS7A, Hertfordshire, United Kingdom). At the 15% contraction level, a train of five stimuli was delivered 10 times at intervals of 4-6 seconds. Measurements were repeated 10 times with 30-second intervals between each set.

Prone position

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being healthy
  • Being between 20 and 40 years of age
  • Being female or male
  • Volunteering to participate

You may not qualify if:

  • Having a history of orthopedic conditions-particularly in the lower extremity-or residual neuromusculoskeletal problems due to previously experienced illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, Istanbul, 34180, Turkey (Türkiye)

Location

Related Publications (5)

  • Burke D, Dickson HG, Skuse NF. Task-dependent changes in the responses to low-threshold cutaneous afferent volleys in the human lower limb. J Physiol. 1991 Jan;432:445-58. doi: 10.1113/jphysiol.1991.sp018393.

  • Aniss AM, Gandevia SC, Burke D. Reflex responses in active muscles elicited by stimulation of low-threshold afferents from the human foot. J Neurophysiol. 1992 May;67(5):1375-84. doi: 10.1152/jn.1992.67.5.1375.

  • Germano AM, Schlee G, Milani TL. Effect of cooling foot sole skin receptors on achilles tendon reflex. Muscle Nerve. 2016 Jun;53(6):965-71. doi: 10.1002/mus.24994. Epub 2016 Apr 26.

  • Nakajima T, Sakamoto M, Tazoe T, Endoh T, Komiyama T. Location specificity of plantar cutaneous reflexes involving lower limb muscles in humans. Exp Brain Res. 2006 Nov;175(3):514-25. doi: 10.1007/s00221-006-0568-6. Epub 2006 Jul 18.

  • Sayenko DG, Vette AH, Obata H, Alekhina MI, Akai M, Nakazawa K. Differential effects of plantar cutaneous afferent excitation on soleus stretch and H-reflex. Muscle Nerve. 2009 Jun;39(6):761-9. doi: 10.1002/mus.21254.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: For the measurement of isometric muscle strength, participants lay prone on an examination table and were instructed to perform maximal plantar flexion for 10 seconds. To achieve a submaximal contraction corresponding to 15% of their maximal voluntary contraction, participants were asked to follow a 15% threshold reference line displayed on the force channel monitor.During the measurement of plantar flexion muscle force, heel skin mechanoreceptors were stimulated using a square-wave electrical current with a pulse duration of 1 microsecond at an intensity three times the sensory threshold. Electrical stimulation was delivered via a constant-current stimulator (Digitimer DS7A, Hertfordshire, United Kingdom). At the 15% contraction level, a train of five stimuli was delivered 10 times at intervals of 4-6 seconds. Measurements were repeated 10 times with 30-second intervals between each set.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Physiatrist

Study Record Dates

First Submitted

February 23, 2026

First Posted

February 27, 2026

Study Start

September 1, 2025

Primary Completion

January 23, 2026

Study Completion

February 20, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations