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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Grip

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PART 1- Group A<br>Male 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 B<br>Male 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 2<br>Male 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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 minutes | 
| 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. | 5 minutes | 
| 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. | 5 minutes | 
| 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 | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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+ | 1 minute | 
| 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+ | 1 minute | 
| 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+ | 1 minute | 
| 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). | 0.5 minute | 
| 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). | 0.5 minute | 
| 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). | 0.5 minute | 
| 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. | 2 minutes | 
| 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. | 2 minutes | 
| 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. | 2 minutes | 
| 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). | 1 minute | 
| 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). | 1 minute | 
| 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). | 1 minute | 
| 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. | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maximum isometric grip strength, Hand-held dynamometer, Reference values, Physical therapy