NCT05832970

Brief Summary

Cryotherapy has beneficial effects such as motor facilitation, increase isometric force generation, and reduce spasticity. It is known that the muscle spindle has sympathetic innervation. Muscle spindle sensitivity increase with sympathetic activity. This research has three hypotheses: First, short-term cold application to the skin increases sympathetic activity. Second, there is an increase in muscle spindle sensitivity with increased sympathetic activity. Third, the effect of short-term cold on muscle spindle sensitivity continues until the skin temperature returns to normal. The purpose of this research is to test these hypotheses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

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

First Submitted

Initial submission to the registry

April 3, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

April 3, 2023

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

4 days

First QC Date

April 3, 2023

Last Update Submit

April 26, 2023

Conditions

Keywords

muscle spindlesympathetic outflowmotor facilitation

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in Heart rate

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

    Baseline (pre-cold pressor test) and 0, 3, 6, 9, 12, 15 minutes post-cold pressor test

  • Change from baseline in Soleus H-reflex

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

    Baseline (pre-cold pressor test) and 0, 3, 6, 9, 12, 15 minutes post-cold pressor test

  • Change from baseline in T-reflex

    Soleus T-reflex will be obtained by hitting the Achilles tendon with the electronic reflex hammer. Its peak to peak amplitude will be measured in microvolts.

    Baseline (pre-cold pressor test) and 0, 3, 6, 9, 12, 15 minutes post-cold pressor test

Secondary Outcomes (1)

  • Skin temperature

    Baseline (pre-cold pressor test) and 0, 3, 6, 9, 12, 15 minutes post-cold pressor test

Study Arms (1)

Hand cooling

EXPERIMENTAL

Records will be taken for Baseline electromyography, Heart rate, H-reflex, and T-reflex measurements before, during, and at 0, 3, 6, 9, 12, and 15. minutes before applying 2-4 degrees Celsius cold to the back of the hand in this group.

Other: Brief skin cooling

Interventions

Brief skin cooling will be applied to the hand using the cold-bath immersion

Hand cooling

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
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 superficial 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

  • ILHAN KARACAN, MD, Prof

    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

April 3, 2023

First Posted

April 27, 2023

Study Start

April 3, 2023

Primary Completion

April 7, 2023

Study Completion

April 8, 2023

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations