NCT06079437

Brief Summary

There is sympathetic innervation of the muscular spindle. The application of cold to the skin provides an increase in sympathetic activity. In rehabilitation practice, short-term local cold is applied to the skin to provide motor facilitation. The aim of this study was to examine whether short-term local cold application provides an increase in isometric contractile strength and, if so, whether this effect is related to muscle spindle activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

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

April 10, 2023

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

10 days

First QC Date

September 29, 2023

Last Update Submit

October 5, 2023

Conditions

Keywords

soleus v-wavesympathetic outflowmuscle spindlecold stress testsympathetic systemcontractile forcemotor facilitation

Outcome Measures

Primary Outcomes (4)

  • Heart rate

    Heart rate was monitored with DII derivation electrocardiographic recording. Heart rate was reported as beats per minute.

    during procedure

  • Soleus H-reflex amplitude

    By stimulating the tibial nerve with an electrical current, the Soleus H-reflex was obtained. Its peak to peak amplitude will be measured in microvolts.

    during procedure

  • Soleus V-wave amplitude

    Soleus V-wave was obtained by applying an electrical current to the tibial nerve during maximum voluntary contraction (MCV). Peak-to-peak amplitude was measured in microvolts.

    during procedure

  • Maximum isometric muscle strength

    Maximum isometric muscle strength of ankle plantar flexors was measured using a force sensor

    during procedure

Secondary Outcomes (1)

  • Skin temperature

    during procedure

Study Arms (1)

experimental group

EXPERIMENTAL

Heart rate, maximum isometric muscle strength, Soleus H-reflex, M-wave, and V-wave measurements were taken in three consecutive periods. First-period maximal isometric contraction; second-period maximal isometric contraction + cold pressure test; third-period maximal isometric contraction + Cheering

Procedure: CheerProcedure: The cold pressure test

Interventions

CheerPROCEDURE

Maximum isometric contraction was performed with cheering.

experimental group

Maximum isometric contraction was performed with the cold pressure test.

experimental group

Eligibility Criteria

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

You may qualify if:

  • Being healthy
  • Being a young adult (20-45 years old)
  • Volunteer

You may not qualify if:

  • Scar, dermatitis, etc. in the skin tissue where the surface electromyography electrode will be placed
  • Upper extremity bone and joint disease, history of neuromuscular disease
  • Heart disease, Hypertension
  • Cold intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Istanbul, 34173, Turkey (Türkiye)

Location

Study Officials

  • Mert Cetin, MD

    İstanbul Physical Therapy Rehabilitation Training & Research Hosptial

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2023

First Posted

October 12, 2023

Study Start

April 10, 2023

Primary Completion

April 20, 2023

Study Completion

April 22, 2023

Last Updated

October 12, 2023

Record last verified: 2023-10

Locations