- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05594888
GRIP: Maximum Isometric Grip Strength Assessed with Three Different Hand-held Dynamometers
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 Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zürich, Switzerland, 8008
- University Hospital Balgrist
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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PART 1- Group A
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:
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PART 1 - Group B
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:
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PART 2
Male and female volunteers (age ≥ 10 years). Maximum isometric grip strength is assessed (no intervention):
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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PART 1: Quality criteria: Intrasubject reliability
Time Frame: 5 minutes
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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
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PART 1: Quality criteria: Intersession reliability
Time Frame: 5 minutes
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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
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PART 1: Quality criteria: Validity
Time Frame: 5 minutes
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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
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PART 2: Comparability of MIGS measurement
Time Frame: 10 minutes
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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PART 2: Age-specific refence values - JAMAR© Hydraulic
Time Frame: 1 minute
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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+
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1 minute
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PART 2: Age-specific refence values - JAMAR© Smart
Time Frame: 1 minute
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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+
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1 minute
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PART 2: Age-specific refence values - Martin Vigorimeter
Time Frame: 1 minute
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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+
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1 minute
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PART 2: Sex-specific refence values - JAMAR© Hydraulic
Time Frame: 0.5 minute
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Sex-specific refence values for MIGS assessed with the , JAMAR© Hydraulic.
Sex is recorded as male or female (biological sex).
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0.5 minute
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PART 2: Sex-specific refence values - JAMAR© Smart
Time Frame: 0.5 minute
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Sex-specific refence values for MIGS assessed with the JAMAR© Smart.
Sex is recorded as male or female (biological sex).
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0.5 minute
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PART 2: Sex-specific refence values - Martin Vigorimeter
Time Frame: 0.5 minute
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Sex-specific refence values for MIGS assessed with the Martin Vigorimeter.
Sex is recorded as male or female (biological sex).
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0.5 minute
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PART 2: Physical activity-specific reference values - JAMAR© Hydraulic
Time Frame: 2 minutes
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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
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PART 2: Physical activity-specific reference values - JAMAR© Smart
Time Frame: 2 minutes
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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
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PART 2: Physical activity-specific reference values - Martin Vigorimeter
Time Frame: 2 minutes
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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
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PART 2: Refence values for subjects with different disease entities - JAMAR© Hydraulic
Time Frame: 1 minute
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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:
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1 minute
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PART 2: Refence values for subjects with different disease entities - JAMAR© Smart
Time Frame: 1 minute
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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:
|
1 minute
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PART 2: Refence values for subjects with different disease entities - Martin Vigorimeter.
Time Frame: 1 minute
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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:
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1 minute
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PART 1 + 2: General health
Time Frame: 10 minutes
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Johannes Scherr, Prof Dr med, Balgrist University Hospital
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- BASEC-Nr.:2022-01400
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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