Study of the Validity and Reliability of Two Digital Dynamometers in Older People
NCT ID: NCT06623019
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
413 participants
OBSERVATIONAL
2024-12-16
2025-04-15
Brief Summary
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Detailed Description
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It will be carried out in two stages: In a first moment the criterion and interobserver validity will be assessed and in a second moment the intraobserver validity. Participants will be randomly assigned to one of the 6 arms to follow different orders of the devices (Device 1, Device 2 or Jamar).
Population: community-dwelling older adults of both sexes over 60 years of age.
Procedures: The investigators will schedule each participant for the initial assessment day. Using a table of random numbers, they will be assigned one of the arms. All participants have previously read, signed and given their written informed consent. An interview will be conducted in which age, sex and medication will be collected; an anthropometric and functional assessment will be performed. The functional tests include the 30-second squat test and grip strength tests using the Jamar, Device 1 and Device 2. Three repetitions will be performed with each device, allowing 30 seconds between repetitions and 3 to 5 minutes between devices. After 20 minutes the test will be repeated again on the devices for interobserver validation. 5 to 10 days later, tester 1 will repeat the grip test with the same effort to assess intraobserver reliability.
Sample size: Similar studies validating grip strength devices compared to the Jamar showed an excellent correlation (ICC \> 0.90). With an estimated ICC of 0.90 ± 0.05 and an alpha risk of 5%, 348 participants are required for the training study.
Variables: Sociodemographic (age, sex, hand dominance, number of medication types), anthropometric (height, weight, BMI and SMI), strength and fatigability (total number of repetitions in 30sCS, maximal grip strength (HGS), fatigue resistance (FR) and grip work (GW)) and device preference.
Statistical analysis: Maximal strength and fatigability will be analyzed by means of means, standard deviations and statistical tests. Concordance between devices will be assessed using the Kappa coefficient and the Bland-Altman concordance index. ROC curves will be used to determine sensitivity and specificity, and data will be analyzed by gender. Results will be considered statistically significant if p \< 0.05, and IBM SPSS Statistics v28.0 will be used for analysis.
Conditions
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Keywords
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Device 1, Device 2 and Jamar®
As this is a validation study, both criterion, inter-observer and intra-observer validation will be performed. Initially, three repetitions will be performed with each device, leaving between 3 and 5 minutes of rest between devices. 20-30 minutes later, the same process will be repeated but with another researcher giving the orders (interobserver reliability). A few days later the same process is repeated with the first investigator (intra-observer reliability). No person will receive any treatment.
Validation and reliability
As this is a cross-sectional validation study, there is no intervention.
Interventions
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Validation and reliability
As this is a cross-sectional validation study, there is no intervention.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Those people who have amputation in one of the two upper limbs or who cannot perform manual grasping for any reason.
* Those who have had an episode of pain in one of the hands during the week prior to the measurement.
* Those who, due to any illness, prevent or contraindicate maximum resistance exercises.
* Any other cause that the research team assesses that may affect the results.
65 Years
ALL
Yes
Sponsors
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University of Salamanca
OTHER
Responsible Party
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Luis Polo Ferrero
Associate Professor
Principal Investigators
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Luis Polo-Ferrero, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Salamanca
Locations
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University of Salamanca
Salamanca, Salamanca, Spain
Countries
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Other Identifiers
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USalamancaValidityDinamometers
Identifier Type: -
Identifier Source: org_study_id