Upper Extremity DysfunctionNCT07407114
Effects of Different Stimuli on Muscle Activation, Hand Grip Strength, Reaction Time, and Hand Function
A study testing Ice and Vibration in people with Upper Extremity Dysfunction, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Extremity Dysfunction
- What is being tested?
- Ice and Vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2023to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Stimuli Applied to the Forearm Flexor Muscles on Muscle Activation, Hand Grip Strength, Reaction Time, and Hand Function
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.
Read more
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.
Read the detailed description
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).
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).
Control Group:
The control group will be planned as a passive control group, and no intervention will be applied. After the initial 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.
- Conditions
- Upper Extremity Dysfunction
- Being tested
- Ice, Vibration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IceOther
Ice will be used as sensory stimulant in this group.
VibrationOther
Vibration will be used as sensory stimulant in this group.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The evaluations were performed at baseline and immediately post-intervention.
Secondary outcomes (2)
Hand Function Measurement
Hand functional performance will be assessed using the Nine-Hole Peg Test (NHPT), a widely used and valid, reliable dexterity test. The test consists of a square platform with nine holes and nine cylindrical pegs that fit into the holes. During the test, participants will be instructed to place the nine pegs into the holes as quickly as possible and, upon completion, immediately remove them and return them to the container.
Measured: The evaluations were performed at baseline and immediately post-intervention.
Upper Extremity Reaction Time Measurement
Upper extremity reaction time will be assessed using the Nelson Visual Hand Reaction Test. Participants will be seated on a chair with the forearm and hand resting comfortably on a table. The thumb and index finger will be positioned approximately 8-10 cm beyond the edge of the table, with the dorsal surfaces of the thumb and index finger parallel to each other in a ready position.The numerical value corresponding to the upper edge of the thumb at the point where the ruler is caught will be read and recorded.
Measured: The evaluations were performed at baseline and immediately post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start30 Mar 2023
- Primary completion30 May 2024
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Healthy young participants.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Seda BAKTIR, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407114
- Sponsor's protocol ID
- LHU-FTR-ZSBD-06
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Stimuli Applied to the Forearm Flexor Muscles on Muscle Activation, Hand Grip Strength, Reaction Time, and Hand Function
- ClinicalTrials.gov ID
- NCT07407114
- Acronym / sponsor ID
- LHU-FTR-ZSBD-06
- Conditions
- Upper Extremity Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
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).
Control Group:
The control group will be planned as a passive control group, and no intervention will be applied. After the initial 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Healthy young participants.
| Arm | Type | Receives |
|---|---|---|
| Group-Ice | Experimental | Other: IceCold 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). |
| Group-Vibr | Active comparator | Other: VibrationVibration 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). |
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IceIce will be used as sensory stimulant in this group. | Other | Group-Ice |
| VibrationVibration will be used as sensory stimulant in this group. | Other | Group-Vibr |
Primary outcome
Muscle Activation Measurement
Time frame: The evaluations were performed at baseline and immediately post-intervention.
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.
Hand Grip Strength Measurement
Time frame: The evaluations were performed at baseline and immediately post-intervention.
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.
2 secondary outcomes
Hand Function Measurement
Time frame: The evaluations were performed at baseline and immediately post-intervention.
Upper Extremity Reaction Time Measurement
Time frame: The evaluations were performed at baseline and immediately post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ice and Vibration in people with Upper Extremity Dysfunction, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Activation Measurement (time frame: The evaluations were performed at baseline and immediately post-intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.