Clinical trial NCT05594888: GRIP: Maximum Isometric Grip Strength Assessed With Three Different Hand-held Dynamometers
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Grip
Keywords: Maximum isometric grip strength
Hand-held dynamometer
Reference values
Physical therapy
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 520
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria Part 1:

* Male and female volunteers with age 18-64 years
* Body mass index \< 30 kg/m2
* Informed consent signed

Inclusion Criteria Part 2:

* Male and female volunteers with age ≥ 10 years
* Informed consent signed (if age \< 14 years, signed by parents or legal guardians)

Exclusion Criteria Part 1 and 2:

* 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

Primary outcomes:
measure: PART 1: Quality criteria: Intrasubject reliability
timeFrame: 5 minutes
measure: PART 1: Quality criteria: Intersession reliability
timeFrame: 5 minutes
measure: PART 1: Quality criteria: Validity
timeFrame: 5 minutes
measure: PART 2: Comparability of MIGS measurement
timeFrame: 10 minutes
Secondary outcomes:
measure: PART 2: Age-specific refence values - JAMAR© Hydraulic
timeFrame: 1 minute
measure: PART 2: Age-specific refence values - JAMAR© Smart
timeFrame: 1 minute
measure: PART 2: Age-specific refence values - Martin Vigorimeter
timeFrame: 1 minute
measure: PART 2: Sex-specific refence values - JAMAR© Hydraulic
timeFrame: 0.5 minute
measure: PART 2: Sex-specific refence values - JAMAR© Smart
timeFrame: 0.5 minute
measure: PART 2: Sex-specific refence values - Martin Vigorimeter
timeFrame: 0.5 minute
measure: PART 2: Physical activity-specific reference values - JAMAR© Hydraulic
timeFrame: 2 minutes
measure: PART 2: Physical activity-specific reference values - JAMAR© Smart
timeFrame: 2 minutes
measure: PART 2: Physical activity-specific reference values - Martin Vigorimeter
timeFrame: 2 minutes
measure: PART 2: Refence values for subjects with different disease entities - JAMAR© Hydraulic
timeFrame: 1 minute
measure: PART 2: Refence values for subjects with different disease entities - JAMAR© Smart
timeFrame: 1 minute
measure: PART 2: Refence values for subjects with different disease entities - Martin Vigorimeter.
timeFrame: 1 minute
measure: PART 1 + 2: General health
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Balgrist
Study officials:
affiliation: Balgrist University Hospital
name: Johannes Scherr, Prof Dr med
role: PRINCIPAL_INVESTIGATOR
References: