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Muscle StrengthNCT07408986

Reference Values and Reliability of Handgrip Strength Assessment Using a Digital Dynamometer in Healthy Adolescents and Other Populations: A Pilot Observational Study

An observational study of Muscle Strength and Reliability, run by University of Extremadura at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

his study aims to establish reference values and examine the reliability of handgrip strength assessment using a digital dynamometer (VALD DynaMo) in healthy adolescents. Participants will undergo standardized strength evaluations of upper and lower limbs, following international testing guidelines. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Muscle Strength Assessment using Digital Handheld Dynamometry (VALD Dynamo®)
How many people
50 participants
Where
1 siteSpain
Study dates
6 Nov 2025to 31 Jan 2026
Phase
Observational
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: The study will include healthy adolescent students (initially aged 15-16 years) from local educational centers collaborating with the University of Extremadura. Participants will undergo non-invasive strength assessments using handheld dynamometry to establish normative reference values. In future phases, the study population may be expanded to include clinical cohorts (e.g., patients with musculoskeletal, neurological, or oncological pathologies) to explore the applicability of dynamometry in clinical assessment and rehabilitation contexts.

Who may be able to join

  • Healthy adolescents aged 15-16 years (for the current phase).
  • Ability to understand and follow verbal instructions.
  • Written informed consent provided by parent or legal guardian (for minors).
  • Assent given by the adolescent participant.
  • In future extensions: individuals aged 10-80 years, including those diagnosed with musculoskeletal, neurological, or oncological conditions, able to safely perform isometric contractions.

Who cannot join

  • History of acute or chronic upper or lower limb injury in the last 6 months.
  • Neurological, cardiovascular, or systemic disorders that may limit maximal effort.
  • Current pain, inflammation, or post-surgical condition affecting muscle performance.
  • Cognitive or communication impairments preventing valid testing.
  • Refusal or withdrawal of informed consent at any point.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Facultad de Medicina y Ciencias de la Salud. Avenida de Elvas s/n

    Badajoz, Badajoz, 06006

Other trials in Spain

About this study

his study aims to establish reference values and examine the reliability of handgrip strength assessment using a digital dynamometer (VALD DynaMo) in healthy adolescents.

Participants will undergo standardized strength evaluations of upper and lower limbs, following international testing guidelines.

Descriptive variables such as age, sex, height, weight, hand dominance, and physical activity level will also be recorded.

The results will contribute to developing normative data and validating the use of portable dynamometry for musculoskeletal health assessment, with potential future applications in clinical populations.

Read the detailed description

Muscle strength is a key indicator of musculoskeletal health and functional capacity across the lifespan. Handgrip strength, in particular, is widely recognized as a simple and reliable marker of overall strength and health status.

However, normative reference values vary across populations, and limited data exist for adolescents in local or regional contexts.

This observational study will collect handgrip and lower limb strength data using the VALD DynaMo portable dynamometer. The measurements will follow standardized testing positions (American Society of Hand Therapists protocol) to ensure reliability and comparability.

The project will also serve as a pilot for future research on populations with musculoskeletal, neurological, or oncological conditions, where muscle strength is often compromised.

Participation is voluntary, non-invasive, and without associated risk. All data will be anonymized and stored securely for research purposes only.

Being tested
Muscle Strength Assessment using Digital Handheld Dynamometry (VALD Dynamo®)
Keywords
Muscle Strength, Hand Strength, Physical Fitness, Adolescent, Reference Values, Reproducibility of Results, Musculoskeletal System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Muscle Strength Assessment using Digital Handheld Dynamometry (VALD Dynamo®)Diagnostic test

    All participants (healthy or clinical) will perform standardized muscle strength tests using the VALD Dynamo® digital dynamometer.

    For upper limb assessments, the protocol will follow the American Society of Hand Therapists (ASHT) recommendations (shoulder neutral, elbow 90°, forearm neutral, wrist 0-30° extension, 0-15° ulnar deviation).

    Lower limb tests will include validated isometric protocols for major muscle groups (quadriceps, hamstrings, hip abductors/adductors).

    Each test will include three maximal voluntary contractions (3 seconds each) with 60 seconds of rest between trials.

    Data will be used to analyze intra- and inter-session reliability, normative reference values, and potential clinical applicability.

Study groups in NCT07408986
Study groupRoleWhat they receive
Healthy Adolescent GroupA single group of healthy adolescents will participate in the study. Each participant will undergo standardized assessments of upper and lower limb muscle strength using digital dynamometry. No treatment or intervention will be applied.
Receives: Diagnostic Test: Muscle Strength Assessment using Digital Handheld Dynamometry (VALD Dynamo®)
Clinical Population Group (Future Recruitment)This group may include participants with musculoskeletal, neurological, or oncological conditions in future phases of the study. The same standardized dynamometry protocol will be applied to compare muscle strength profiles and assess the applicability of the measurement tools in clinical populations.
Receives: Diagnostic Test: Muscle Strength Assessment using Digital Handheld Dynamometry (VALD Dynamo®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal Isometric Muscle Strength (Handgrip and Lower Limb)

    Peak isometric force (in Newtons or kilograms) recorded using a VALD Dynamo® handheld digital dynamometer.

    Measurements will follow standardized positioning protocols recommended by the American Society of Hand Therapists (ASHT) for upper limb and by recent literature for lower limb testing.

    Each participant will perform three maximal voluntary contractions per muscle group, with the highest value recorded for analysis. Unit of Measure: Newtons (N) or Kilograms.

    Measured: Single testing session (baseline).

Secondary outcomes (3)
  1. Test-Retest Reliability of Muscle Strength Measures. Maximal Isometric Muscle Strength Handgrip

    VALD Dynamo®: Assessment of intra-rater reliability of dynamometry results across two sessions separated by 7-14 days, in a subset of participants and intra-session.

    Reliability will be quantified using Intraclass Correlation Coefficients (ICC), Standard Error of Measurement (SEM), and Coefficient of Variation (CV). (%)

    Measured: Two sessions separated by 7-14 days.

  2. Descriptive Anthropometric and Activity Variables

    Age, sex, height, body weight, body mass index (BMI), dominant hand, and self-reported physical activity level (frequency and type of sport practiced per week).

    These variables will be analyzed to explore associations with muscle strength outcomes.

    Measured: Collected at baseline (single session).

  3. Clinical Applicability (Optional Future Arm). Maximal Isometric Muscle Strength (Handgrip)

    Comparison of muscle strength (kg) profiles between healthy participants and individuals with musculoskeletal, neurological, or oncological conditions (if included in later phases).

    Outcomes will explore between-group differences and responsiveness of the measurement tool in clinical contexts.

    Measured: To be determined in future phases

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2026
  2. Study start6 Nov 2025
  3. Primary completion6 Nov 2025
  4. Study completion31 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07408986
Sponsor's protocol ID
061125
Status last verified
Feb 2026
First submitted
3 Feb 2026
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Muscle Strength and Reliability, run by University of Extremadura at 1 site in Spain.

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 5 inclusion and 5 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 13 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 Spain. 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?

Maximal Isometric Muscle Strength (Handgrip and Lower Limb) (time frame: Single testing session (baseline).). 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 13 Feb 2026.

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