- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07439705
The Effect of Heel Skin Mechanoreceptors on Plantar Flexor Contraction Force
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34180
- Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being healthy
- Being between 20 and 40 years of age
- Being female or male
- Volunteering to participate
Exclusion Criteria:
- Having a history of orthopedic conditions-particularly in the lower extremity-or residual neuromusculoskeletal problems due to previously experienced illnesses
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 |
|---|---|
|
Experimental: Prone position
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.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Voluntary Contraction Force
Time Frame: Day 1 (During a single experimental session)
|
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
Time Frame: Day 1 (During a single experimental session)
|
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
Time Frame: Day 1 (During a single experimental session)
|
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)
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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 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
- 2025-58
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
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