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GripNCT05594888

GRIP: Maximum Isometric Grip Strength Assessed With Three Different Hand-held Dynamometers

An observational study of Grip, run by Johannes Scherr at 1 site in Switzerland.

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

Maximum isometric grip strength (MIGS) is a cost-effective, easily accessible, valid and reliable outcome measure for assessing upper body strength in both, adults and children. The the JAMAR Hydraulic Hand Dynamometer is the current gold standard for measuring MIGS. Read more about this study

Who is it for?
Ages 10 years and olderHealthy volunteers can take part
Conditions the study is for
Grip
How many people
520 participants
Where
1 siteSwitzerland
Study dates
17 Nov 2022to 31 Jan 2025
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 10 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Part 1: * Male and female volunteers (age 18-64 years) working at University Hospital Balgrist. * 40 participants: to exclude possible sex aspects, ratio ♀: ♂ = 1:1 Part 2: * Male and female volunteers (age ≥ 10 years). MIGS is used as a health indicator throughout different age- and sex groups. * 20 participants per age-group and sex with a total of 520 subjects are planned

Who may be able to join

  • Male and female volunteers with age 18-64 years
  • Body mass index < 30 kg/m2
  • Informed consent signed
  • Male and female volunteers with age ≥ 10 years
  • Informed consent signed (if age < 14 years, signed by parents or legal guardians)

Who cannot join

  • Disease or injury (e.g., musculoskeletal or neurological) that could affect upper extremity strength
  • Physical impairment of the upper extremity (visible swelling or the presence of a splint or cast)
  • Acute pain or infection
  • Cognitive impairment (inability to understand and/or follow directions)
  • Insufficient language of the German language

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • University Hospital Balgrist

    Zurich, Canton of Zurich, 8008

Other trials in Switzerland

About this study

Official title: GRIP: Evaluation of the Comparability of the Maximum Isometric Grip Strength Measurement Assessed With the JAMAR© Hydraulic Hand Dynamometer, the JAMAR© Smart Hand Dynamometer and the Martin Vigorimeter

Maximum isometric grip strength (MIGS) is a cost-effective, easily accessible, valid and reliable outcome measure for assessing upper body strength in both, adults and children. The the JAMAR Hydraulic Hand Dynamometer is the current gold standard for measuring MIGS. For certain age- and activity-groups, alternative devices may be more appropriate. To date, the quality criteria (test-retest-reliability and validity) of the JAMAR Smart Hand Dynamometer and the Martin Vigorimeter compared to the current gold standard are not yet investigated. Furthermore, no reference values for different age-, sex-, or activity level groups exist with regard to underlying disease entities for these three devices.

Read the detailed description

This quality analysis of test-retest reliability and validity (PART 1) serves as a basis for a further sensitivity analysis, whereby in a second step, a database with valid personalised age-, sex- and activity-related reference values for the respective measurement instrument, considering chronic concomitant diseases, is to be generated. The objectives of this study are therefore to 1) assess the test-retest reliability (intrasubject and intersession) and validity of JAMAR© Hydraulic and JAMAR© Smart dynamometers and Martin Vigorimeter (PART 1) and 2) undertake a sensitivity analysis providing valid personalised reference values for precision medicine (PART 2).

Thus, no study has yet comprehensively investigated all relevant influencing factors in a single and thus homogeneous study setting, so bias can be expected from this alone. The findings of this two-step study should enable physicians and therapists to compare the grip strength measurements of their patients with normative values in relation to their age, sex and activity group, as well as to any underlying chronic diseases that may be present. This allows realistic treatment and training goals to be set and patient performance to be interpreted.

Conditions
Grip
Keywords
Maximum isometric grip strength, Hand-held dynamometer, Reference values, Physical therapy

What participants receive

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

Study groups in NCT05594888
Study groupRoleWhat they receive
PART 1- Group AMale and female volunteers (age 18-64 years) working at University Hospital Balgrist. Assessment of validity and intrasubject reliability of maximum isometric grip strength assessed with: * JAMAR© Smart Dynamometer [kg] * JAMAR© Hydraulic Dynamometer [kg] * Martin Vigorimeter [kPa]
PART 1 - Group BMale and female volunteers (age 18-64 years) working at University Hospital Balgrist. Assessment of validity and intrasubject reliability and assessment of intersession reliability of maximum isometric grip strength assessed with: * JAMAR© Smart Dynamometer [kg] * JAMAR© Hydraulic Dynamometer [kg] * Martin Vigorimeter [kPa]
PART 2Male and female volunteers (age ≥ 10 years). Maximum isometric grip strength is assessed (no intervention): * JAMAR© Smart Dynamometer [kg] * JAMAR© Hydraulic Dynamometer [kg] * Martin Vigorimeter [KPa]

What is being measured

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

  1. PART 1: Quality criteria: Intrasubject reliability

    Test-retest reliability of the JAMAR© Smart Dynamometer, the JAMAR© Hydraulic Dynamometer and Martin Vigorimeter measuring MIGS will be assessed by intrasubject realiability.

    --> 5 attempts per device and dominant/adominant hand will be measured.

    Measured: 5 minutes

  2. PART 1: Quality criteria: Intersession reliability

    Test-retest reliability of the JAMAR© Smart Dynamometer, the JAMAR© Hydraulic Dynamometer and Martin Vigorimeter measuring MIGS will be assessed by intersession realiability.

    --> 5 attempts per device and dominant/adominant hand at two different days will be measured.

    Measured: 5 minutes

  3. PART 1: Quality criteria: Validity

    Validity of the JAMAR© Smart Dynamometer, the JAMAR© Hydraulic Dynamometer and Martin Vigorimeter measuring MIGS will be assessed by plotting the differences in grip force measurements of the 3 measurement devices against their means, with ± 1.96 SD as cut-off values (limits of agreement).

    --> 5 attempts per device and dominant/adominant hand will be measured.

    Measured: 5 minutes

  4. PART 2: Comparability of MIGS measurement

    Evaluation of comparability of MIGS measurement assessed with the JAMAR© Smart Dynamometer, the JAMAR© Hydraulic Dynamometer and the Martin Vigorimeter

    -> Best out of 3 attempts per device and dominant/adominant hand

    Measured: 10 minutes

Secondary outcomes (13)
  1. PART 2: Age-specific refence values - JAMAR© Hydraulic

    Age-specific refence values for MIGS assessed with the JAMAR© Hydraulic. Age is assessed by the number of years. Thirteen age groups are established with an increment of five to ten years: 10-14/15-19/20- 29/30-39/40-44/45-49/50-54/55-59/60-64/65-69/70-74/75-79/80+

    Measured: 1 minute

  2. PART 2: Age-specific refence values - JAMAR© Smart

    Age-specific refence values for MIGS assessed with the JAMAR© Smart. Age is assessed by the number of years. Thirteen age groups are established with an increment of five to ten years: 10-14/15-19/20- 29/30-39/40-44/45-49/50-54/55-59/60-64/65-69/70-74/75-79/80+

    Measured: 1 minute

  3. PART 2: Age-specific refence values - Martin Vigorimeter

    Age-specific refence values for MIGS assessed with the Martin Vigorimeter. Age is assessed by the number of years. Thirteen age groups are established with an increment of five to ten years: 10-14/15-19/20- 29/30-39/40-44/45-49/50-54/55-59/60-64/65-69/70-74/75-79/80+

    Measured: 1 minute

  4. PART 2: Sex-specific refence values - JAMAR© Hydraulic

    Sex-specific refence values for MIGS assessed with the , JAMAR© Hydraulic. Sex is recorded as male or female (biological sex).

    Measured: 0.5 minute

  5. PART 2: Sex-specific refence values - JAMAR© Smart

    Sex-specific refence values for MIGS assessed with the JAMAR© Smart. Sex is recorded as male or female (biological sex).

    Measured: 0.5 minute

  6. PART 2: Sex-specific refence values - Martin Vigorimeter

    Sex-specific refence values for MIGS assessed with the Martin Vigorimeter. Sex is recorded as male or female (biological sex).

    Measured: 0.5 minute

  7. PART 2: Physical activity-specific reference values - JAMAR© Hydraulic

    Physical activity-specific reference values for MIGS measurements assessed with the JAMAR© Hydraulic.

    The IPAQ, the PAQ-A and the PAQ-C are used to assess individual levels of physical activity through all age groups. The IPAQ is a reliable and valid instrument that shows very good repeatability, was designed for people aged 18-65 years and is validated for persons aged 18-84 years. Adolescents between 15 and 18 years of age are assessed using the PAQ-A and children aged 10-14 years are assessed by the PAQ-C.

    Measured: 2 minutes

  8. PART 2: Physical activity-specific reference values - JAMAR© Smart

    Physical activity-specific reference values for MIGS measurements assessed with the JAMAR© Smart.

    The IPAQ, the PAQ-A and the PAQ-C are used to assess individual levels of physical activity through all age groups. The IPAQ is a reliable and valid instrument that shows very good repeatability, was designed for people aged 18-65 years and is validated for persons aged 18-84 years. Adolescents between 15 and 18 years of age are assessed using the PAQ-A and children aged 10-14 years are assessed by the PAQ-C.

    Measured: 2 minutes

  9. PART 2: Physical activity-specific reference values - Martin Vigorimeter

    Physical activity-specific reference values for MIGS measurements assessed with the Martin Vigorimeter.

    The IPAQ, the PAQ-A and the PAQ-C are used to assess individual levels of physical activity through all age groups. The IPAQ is a reliable and valid instrument that shows very good repeatability, was designed for people aged 18-65 years and is validated for persons aged 18-84 years. Adolescents between 15 and 18 years of age are assessed using the PAQ-A and children aged 10-14 years are assessed by the PAQ-C.

    Measured: 2 minutes

  10. PART 2: Refence values for subjects with different disease entities - JAMAR© Hydraulic

    Refence values for subjects with different disease entities that might influence target value of MIGS measurement assessed with the JAMAR© Hydraulic

    Any chronic disease entities that may be present, (possible chronic diseases according to organ class) are recorded:

    • Pulmonary (e.g., COPD)
    • Cardiac (e.g., CHF)
    • Neurological (apoplexy, PNP)
    • Gastroenterological (e.g., chronic gastritis)
    • Gynaecological (e.g., endometriosis)
    • Rheumatic (e.g., arthritis)
    • Oncological
    • Musculoskeletal (e.g., spine, lower extremities)
    • Metabolic (e.g., diabetes mellitus).

    Measured: 1 minute

  11. PART 2: Refence values for subjects with different disease entities - JAMAR© Smart

    Refence values for subjects with different disease entities that might influence target value of MIGS measurement assessed with the JAMAR© Smart

    Any chronic disease entities that may be present, (possible chronic diseases according to organ class) are recorded:

    • Pulmonary (e.g., COPD)
    • Cardiac (e.g., CHF)
    • Neurological (apoplexy, PNP)
    • Gastroenterological (e.g., chronic gastritis)
    • Gynaecological (e.g., endometriosis)
    • Rheumatic (e.g., arthritis)
    • Oncological
    • Musculoskeletal (e.g., spine, lower extremities)
    • Metabolic (e.g., diabetes mellitus).

    Measured: 1 minute

  12. PART 2: Refence values for subjects with different disease entities - Martin Vigorimeter.

    Refence values for subjects with different disease entities that might influence target value of MIGS measurement assessed with the Martin Vigorimeter.

    Any chronic disease entities that may be present, (possible chronic diseases according to organ class) are recorded:

    • Pulmonary (e.g., COPD)
    • Cardiac (e.g., CHF)
    • Neurological (apoplexy, PNP)
    • Gastroenterological (e.g., chronic gastritis)
    • Gynaecological (e.g., endometriosis)
    • Rheumatic (e.g., arthritis)
    • Oncological
    • Musculoskeletal (e.g., spine, lower extremities)
    • Metabolic (e.g., diabetes mellitus).

    Measured: 1 minute

  13. PART 1 + 2: General health

    The OSTRC questionnaire is used to assess general health before the first study appointment.

    The OSTRC contains four key questions recording the level of participation and performance impairment and the degree of symptoms caused by injury or illness. A severity score is then calculated based on these four questions.

    Measured: 10 minutes

Timeline

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

  1. First posted26 Oct 2022
  2. Study start17 Nov 2022
  3. Primary completion31 Jan 2025
  4. Study completion31 Jan 2025

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
Other
Time perspective
Prospective
Enrolment
520 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05594888
Sponsor's protocol ID
BASEC-Nr.:2022-01400
Status last verified
Feb 2025
First submitted
2 Oct 2022
Last updated
11 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Grip, run by Johannes Scherr at 1 site in Switzerland.

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 11 Feb 2025. 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 Switzerland. 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?

PART 1: Quality criteria: Intrasubject reliability (time frame: 5 minutes). The study lists 4 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 11 Feb 2025.

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