- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07408986
Reference Values and Reliability of Handgrip Strength Assessment Using a Digital Dynamometer in Healthy Adolescents and Other Populations: A Pilot Observational 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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Badajoz
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Badajoz, Badajoz, Spain, 06006
- Facultad de Medicina y Ciencias de la Salud. Avenida de Elvas s/n
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy Adolescent Group
A 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.
|
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. |
|
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximal Isometric Muscle Strength (Handgrip and Lower Limb)
Time Frame: Single testing session (baseline).
|
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. |
Single testing session (baseline).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Test-Retest Reliability of Muscle Strength Measures. Maximal Isometric Muscle Strength Handgrip
Time Frame: Two sessions separated by 7-14 days.
|
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). (%) |
Two sessions separated by 7-14 days.
|
|
Descriptive Anthropometric and Activity Variables
Time Frame: Collected at baseline (single session).
|
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. |
Collected at baseline (single session).
|
|
Clinical Applicability (Optional Future Arm). Maximal Isometric Muscle Strength (Handgrip)
Time Frame: To be determined in future phases
|
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. |
To be determined in future phases
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 061125
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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