NCT07407114

Brief Summary

The study will include three separate intervention groups: an ice application group, a vibration application group, and a control group. Accordingly, three groups were randomly generated using the Research Randomizer software. To determine the group allocation of the participants, individuals will be asked to draw a number from a bag containing numbers, each written only once. The intervention corresponding to the drawn number will be applied to the participant. All interventions will be administered by the researcher Demet Öztürk, while the outcome measurements will be evaluated by the researchers Seda Baktır Doğan and Mustafa Sarı. The interventions and assessment procedures will be conducted in separate rooms in order to ensure assessor blinding. Participants included in the study will first complete a Demographic Data Form. This form will record demographic information including age, sex, body weight, height, dominant side, alcohol consumption status, medical history, and family history. Following the relevant tactile stimulus application, participants' hand grip strength, muscle activation, hand function, and upper extremity reaction time will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

January 29, 2026

Last Update Submit

February 10, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Muscle Activation Measurement

    Surface (non-invasive) electromyography (EMG) will be used to assess muscle activation using the Trigno™ Wireless System (Delsys Inc., USA). EMG recordings will be obtained from the flexor carpi radialis, flexor carpi ulnaris, flexor digitorum superficialis, and flexor digitorum profundus muscles. Electrode placement on the target muscles will be determined according to the SENIAM recommendations and previously published studies.

    The evaluations were performed at baseline and immediately post-intervention.

  • Hand Grip Strength Measurement

    Gross hand grip strength will be assessed using an electronic hand dynamometer (Baseline 12-0286 Electronic Smedley Hand Dynamometer, 200 lbs capacity). Measurements will be performed according to the standard testing protocol recommended by the American Society of Hand Therapists. Participants will be seated upright in a chair with back support, with the shoulder adducted and in a neutral position, the elbow flexed at 90°, and the forearm and wrist in a neutral position. The dynamometer will be held vertically, perpendicular to the floor. Participants will be instructed to hold the dynamometer with one hand and squeeze it as forcefully as possible.

    The evaluations were performed at baseline and immediately post-intervention.

Secondary Outcomes (2)

  • Hand Function Measurement

    The evaluations were performed at baseline and immediately post-intervention.

  • Upper Extremity Reaction Time Measurement

    The evaluations were performed at baseline and immediately post-intervention.

Study Arms (3)

Group-Ice

EXPERIMENTAL

Cold Application (Ice Therapy): Ice application will be administered to the forearm flexor muscle group. The application will be performed using a gel pack available in the Physiotherapy and Rehabilitation Laboratory. The gel pack will be kept in a refrigerator for at least 20 minutes prior to application. The pack will be placed between wet towels and applied continuously to the target area for 3 minutes (reference).

Other: Ice

Group-Vibr

ACTIVE COMPARATOR

Vibration Application: Vibration therapy will be applied using the Compex Fixx 1.0 device. The device has three different vibration speed levels. In the present study, vibration will be applied to the forearm flexor muscle groups for 3 minutes at the first speed level (1500 RPMs; Power: W / Voltage: 12.0 V / Current: 0.28 A / Sound level: 57-60 dB).

Other: Vibration

Croup-Cont

NO INTERVENTION

Control Group: In the present study, the control group will be planned as a passive control group, and no intervention will be applied. After the baseline measurements, participants will rest in the intervention room for 3 minutes (equal to the duration of the other interventions), followed by post-intervention assessments conducted in the assessment room.

Interventions

IceOTHER

Ice will be used as sensory stimulant in this group.

Group-Ice

Vibration will be used as sensory stimulant in this group.

Group-Vibr

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult individuals aged between 18 and 35 years
  • Voluntary participants who have read and signed the informed consent form will be included in the study

You may not qualify if:

  • Individuals with any systemic, inflammatory, neurological, or degenerative disease affecting the upper extremity
  • Individuals with acute inflammation or inflammatory disorders, acute thrombosis, cardiovascular/circulatory diseases, migraine, or epilepsy
  • Individuals with a history of trauma or surgery involving the upper extremity within the past year
  • Individuals who have started using medications within the last 6 months that may affect the nervous or musculoskeletal systems
  • Individuals with implanted metallic foreign bodies in the upper extremity
  • Individuals with a pacemaker
  • Individuals with circulatory disorders in the upper extremity
  • Individuals with any diagnosed sensory impairment
  • Individuals with any health condition (e.g., visual or cognitive impairment) that may prevent the proper completion of the assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lokman Hekim University

Ankara, Cankaya, Turkey (Türkiye)

Location

MeSH Terms

Interventions

IceVibration

Intervention Hierarchy (Ancestors)

WaterHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsEnvironmentEcological and Environmental PhenomenaBiological PhenomenaWeatherMeteorological ConceptsEnvironment and Public HealthMechanical PhenomenaPhysical Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assesors are blind to study.
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Healthy young participants.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 12, 2026

Study Start

March 30, 2023

Primary Completion

May 30, 2024

Study Completion

November 30, 2025

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations