Healthy VolunteersNCT07745829
Effect of Single-Session HVPGS on Hand Grip Strength and Reaction Time in Healthy Individuals
A study testing High-Voltage Pulsed Galvanic Stimulation (HVPGS) in people with Healthy Volunteers and Muscle Strength, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this cross-sectional study is to investigate the immediate (acute) effects of a single session of High-Voltage Pulsed Galvanic Stimulation (HVPGS) on hand muscle strength and reaction time in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Muscle Strength, Reaction Time
- What is being tested?
- High-Voltage Pulsed Galvanic Stimulation (HVPGS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2025to 11 Aug 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy academic and administrative staff, or senior physical therapy and rehabilitation students of Kırşehir Ahi Evran University.
- Aged between 18 and 65 years.
- Voluntary participation with signed written informed consent provided prior to enrollment.
Who cannot join
- Self-reported elbow, hand, shoulder, or neck discomfort in the past 6 months.
- Presence of active upper extremity pain.
- Neurological disorders affecting upper extremity sensation or motor execution.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Single-Session Electrostimulation on Grip Strength and Hand Reaction in Healthy Individuals: A Cross-Sectional Observational Study
The aim of this cross-sectional study is to investigate the immediate (acute) effects of a single session of High-Voltage Pulsed Galvanic Stimulation (HVPGS) on hand muscle strength and reaction time in healthy adults.
A total of 42 healthy volunteers aged 18 to 65 years undergo a single session of HVPGS applied to the forearm flexor muscles (m. flexor digitorum superficialis, m. flexor digitorum profundus, and m. flexor pollicis longus). Isometric hand grip strength is evaluated before (T0) and immediately after (T1) the intervention using a Jamar hand dynamometer. Sensorimotor reaction time is measured at the same time points using the Nelson Hand Reaction Test.
The study aims to determine whether acute HVPGS application elicits immediate bilateral enhancements in mechanical force production and central-mediated processing speed, and whether these gains interact with demographic factors or hemispheric hand dominance.
Read the detailed description
Background and Rationale:Neuromuscular Electrical Stimulation (NMES) is widely utilized to enhance force production and neural excitability in both clinical and sports settings. High-Voltage Pulsed Galvanic Stimulation (HVPGS) is a unique electrotherapeutic modality characterized by an ultra-short pulse duration and high-voltage peak intensity. Due to its specific wave architecture, HVPGS exhibits reduced capacitive skin impedance, allowing electrical current to penetrate deeper into muscle bellies with minimal cutaneous discomfort. While conventional NMES protocols often induce acute localized fatigue, HVPGS has shown potential as an acute peripheral priming tool. However, evidence regarding its immediate, single-session effects on concurrent motor output (grip strength) and central sensorimotor processing speed (reaction time) remains limited.Study Design and Setting:This cross-sectional, single-arm interventional study was conducted in the Orthopedic Rehabilitation Unit of the School of Physical Therapy and Rehabilitation at Kırşehir Ahi Evran University. The protocol was approved by the Clinical Research Ethics Committee of Kırşehir Ahi Evran University (Approval Number: 2025-15/191) and executed in compliance with the Declaration of Helsinki.Participants and Eligibility:A sample of 42 healthy volunteers aged 18 to 65 years was enrolled, including university academic/administrative staff and senior physical therapy students. Sample size was determined via a priori power analysis in G*Power 3.1.9.2 ($d = 0.79$, $\alpha = 0.05$, $1-\beta = 0.80$). Exclusion criteria comprised any self-reported neck or upper extremity discomfort/pain within the preceding 6 months or neurological disorders affecting sensation and motor execution.Study Procedures and Intervention:Baseline Assessment (T0): Participants completed baseline evaluations of bilateral isometric hand grip strength using a Jamar hydraulic hand dynamometer (seated position, 90° elbow flexion; 3 consecutive trials averaged in kg) and sensorimotor reaction time using the Nelson Hand Reaction Test (5 trials, middle 3 trials averaged in cm).Electrostimulation Intervention: Participants received a single session of HVPGS applied to the forearm flexor muscle group (m. flexor digitorum superficialis, m. flexor digitorum profundus, and m. flexor pollicis longus). The intervention followed an intermittent duty cycle consisting of 7 seconds of active stimulation followed by 14 seconds of rest. The procedure was directly supervised by an expert physiotherapist with 21 years of clinical experience in electrotherapy.Post-Intervention Assessment (T1): Immediately following the completion of the HVPGS session, identical grip strength and reaction time measurements were conducted to record acute functional changes.Statistical Analysis:Data analysis was performed using R statistical software. Pre- and post-intervention changes ($\Delta = \text{Post} - \text{Pre}$) were calculated. Normality was evaluated via Shapiro-Wilk tests. Depending on distributional normality, paired-samples t-tests or Wilcoxon signed-rank tests were executed to detect immediate therapeutic changes. Secondary interactions with demographic variables (Age, BMI) and subgroups (Sex, Hand Dominance) were analyzed using Pearson/Spearman correlation coefficients and independent t-tests / Mann-Whitney U tests.
- Being tested
- High-Voltage Pulsed Galvanic Stimulation (HVPGS)
- Keywords
- High-Voltage Pulsed Galvanic Stimulation, Electrostimulation, Reaction Time, Neuromuscular Priming, Electrophysiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Voltage Pulsed Galvanic Stimulation (HVPGS)Device
Application of a single session of High-Voltage Pulsed Galvanic Stimulation (HVPGS) targeting the forearm flexor muscles (m. flexor digitorum superficialis, m. flexor digitorum profundus, and m. flexor pollicis longus). The intervention uses an intermittent duty cycle consisting of 7 seconds of active stimulation followed by 14 seconds of rest, delivered under the direct supervision of an expert physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants receive a single session of High-Voltage Pulsed Galvanic Stimulation (HVPGS) applied to the forearm flexor muscles (m. flexor digitorum superficialis, m. flexor digitorum profundus, and m. flexor pollicis longus). The protocol utilizes an intermittent stimulation cycle of 7 seconds of active stimulation followed by 14 seconds of rest. Immediate pre- and post-intervention evaluations measure isometric hand grip strength and sensorimotor reaction time. Receives: Device: High-Voltage Pulsed Galvanic Stimulation (HVPGS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate Change in Isometric Hand Grip Strength
Measured in kilograms (kg) using a Jamar hydraulic hand dynamometer in a standardized seated position with 90 degrees of elbow flexion. Three consecutive trials are performed and averaged.
Measured: Baseline (T0) and Immediately Post-Intervention (T1)
Immediate Change in Sensorimotor Reaction Time
Measured in centimeters (cm) using the Nelson Hand Reaction Test. Five trials are performed, and the average of the middle three values is recorded.
Measured: Baseline (T0) and Immediately Post-Intervention (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start10 Jun 2025
- Primary completion10 Aug 2025
- Study completion11 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Faruk ÖZÇELEP, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745829
- Sponsor's protocol ID
- 2025-15/191
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified (anonymized) individual participant data collected during the study, including demographic characteristics, baseline measurements, and post-intervention grip strength and reaction time scores, will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Single-Session Electrostimulation on Grip Strength and Hand Reaction in Healthy Individuals: A Cross-Sectional Observational Study
- ClinicalTrials.gov ID
- NCT07745829
- Acronym / sponsor ID
- 2025-15/191
- Keywords
- High-Voltage Pulsed Galvanic Stimulation, Electrostimulation, Reaction Time, Neuromuscular Priming, Electrophysiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 10 Aug 2025 (actual)
- Study completion
- 11 Aug 2025 (actual)
- First posted
- 4 Aug 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 aim of this cross-sectional study is to investigate the immediate (acute) effects of a single session of High-Voltage Pulsed Galvanic Stimulation (HVPGS) on hand muscle strength and reaction time in healthy adults.
A total of 42 healthy volunteers aged 18 to 65 years undergo a single session of HVPGS applied to the forearm flexor muscles (m. flexor digitorum superficialis, m. flexor digitorum profundus, and m. flexor pollicis longus). Isometric hand grip strength is evaluated before (T0) and immediately after (T1) the intervention using a Jamar hand dynamometer. Sensorimotor reaction time is measured at the same time points using the Nelson Hand Reaction Test.
The study aims to determine whether acute HVPGS application elicits immediate bilateral enhancements in mechanical force production and central-mediated processing speed, and whether these gains interact with demographic factors or hemispheric hand dominance.
Detailed description
Background and Rationale:Neuromuscular Electrical Stimulation (NMES) is widely utilized to enhance force production and neural excitability in both clinical and sports settings. High-Voltage Pulsed Galvanic Stimulation (HVPGS) is a unique electrotherapeutic modality characterized by an ultra-short pulse duration and high-voltage peak intensity. Due to its specific wave architecture, HVPGS exhibits reduced capacitive skin impedance, allowing electrical current to penetrate deeper into muscle bellies with minimal cutaneous discomfort. While conventional NMES protocols often induce acute localized fatigue, HVPGS has shown potential as an acute peripheral priming tool. However, evidence regarding its immediate, single-session effects on concurrent motor output (grip strength) and central sensorimotor processing speed (reaction time) remains limited.Study Design and Setting:This cross-sectional, single-arm interventional study was conducted in the Orthopedic Rehabilitation Unit of the School of Physical Therapy and Rehabilitation at Kırşehir Ahi Evran University. The protocol was approved by the Clinical Research Ethics Committee of Kırşehir Ahi Evran University (Approval Number: 2025-15/191) and executed in compliance with the Declaration of Helsinki.Participants and Eligibility:A sample of 42 healthy volunteers aged 18 to 65 years was enrolled, including university academic/administrative staff and senior physical therapy students. Sample size was determined via a priori power analysis in G*Power 3.1.9.2 ($d = 0.79$, $\alpha = 0.05$, $1-\beta = 0.80$). Exclusion criteria comprised any self-reported neck or upper extremity discomfort/pain within the preceding 6 months or neurological disorders affecting sensation and motor execution.Study Procedures and Intervention:Baseline Assessment (T0): Participants completed baseline evaluations of bilateral isometric hand grip strength using a Jamar hydraulic hand dynamometer (seated position, 90° elbow flexion; 3 consecutive trials averaged in kg) and sensorimotor reaction time using the Nelson Hand Reaction Test (5 trials, middle 3 trials averaged in cm).Electrostimulation Intervention: Participants received a single session of HVPGS applied to the forearm flexor muscle group (m. flexor digitorum superficialis, m. flexor digitorum profundus, and m. flexor pollicis longus). The intervention followed an intermittent duty cycle consisting of 7 seconds of active stimulation followed by 14 seconds of rest. The procedure was directly supervised by an expert physiotherapist with 21 years of clinical experience in electrotherapy.Post-Intervention Assessment (T1): Immediately following the completion of the HVPGS session, identical grip strength and reaction time measurements were conducted to record acute functional changes.Statistical Analysis:Data analysis was performed using R statistical software. Pre- and post-intervention changes ($\Delta = \text{Post} - \text{Pre}$) were calculated. Normality was evaluated via Shapiro-Wilk tests. Depending on distributional normality, paired-samples t-tests or Wilcoxon signed-rank tests were executed to detect immediate therapeutic changes. Secondary interactions with demographic variables (Age, BMI) and subgroups (Sex, Hand Dominance) were analyzed using Pearson/Spearman correlation coefficients and independent t-tests / Mann-Whitney U tests.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: High-Voltage Pulsed Galvanic Stimulation (HVPGS)Participants receive a single session of High-Voltage Pulsed Galvanic Stimulation (HVPGS) applied to the forearm flexor muscles (m. flexor digitorum superficialis, m. flexor digitorum profundus, and m. flexor pollicis longus). The protocol utilizes an intermittent stimulation cycle of 7 seconds of active stimulation followed by 14 seconds of rest. Immediate pre- and post-intervention evaluations measure isometric hand grip strength and sensorimotor reaction time. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy academic and administrative staff, or senior physical therapy and rehabilitation students of Kırşehir Ahi Evran University.
- Aged between 18 and 65 years.
- Voluntary participation with signed written informed consent provided prior to enrollment.
Key exclusion criteria (3 listed)
- Self-reported elbow, hand, shoulder, or neck discomfort in the past 6 months.
- Presence of active upper extremity pain.
- Neurological disorders affecting upper extremity sensation or motor execution.
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 |
|---|---|---|
| High-Voltage Pulsed Galvanic Stimulation (HVPGS)Application of a single session of High-Voltage Pulsed Galvanic Stimulation (HVPGS) targeting the forearm flexor muscles (m. flexor digitorum superficialis, m. flexor digitorum profundus, and m. flexor pollicis longus). The intervention uses an intermittent duty cycle consisting of 7 seconds of active stimulation followed by 14 seconds of rest, delivered under the direct supervision of an expert physiotherapist. | Device | Experimental |
Primary outcome
Immediate Change in Isometric Hand Grip Strength
Time frame: Baseline (T0) and Immediately Post-Intervention (T1)
Measured in kilograms (kg) using a Jamar hydraulic hand dynamometer in a standardized seated position with 90 degrees of elbow flexion. Three consecutive trials are performed and averaged.
Immediate Change in Sensorimotor Reaction Time
Time frame: Baseline (T0) and Immediately Post-Intervention (T1)
Measured in centimeters (cm) using the Nelson Hand Reaction Test. Five trials are performed, and the average of the middle three values is recorded.
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 4 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified (anonymized) individual participant data collected during the study, including demographic characteristics, baseline measurements, and post-intervention grip strength and reaction time scores, will be made available upon reasonable request.
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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 High-Voltage Pulsed Galvanic Stimulation (HVPGS) in people with Healthy Volunteers and Muscle Strength, run by Kirsehir Ahi Evran Universitesi 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 3 inclusion and 3 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 4 Aug 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?
Immediate Change in Isometric Hand Grip Strength (time frame: Baseline (T0) and Immediately Post-Intervention (T1)). 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 4 Aug 2026.