NCT05594888

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

November 17, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

2.2 years

First QC Date

October 2, 2022

Last Update Submit

February 9, 2025

Conditions

Keywords

Maximum isometric grip strengthHand-held dynamometerReference valuesPhysical therapy

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (13)

  • PART 2: Age-specific refence values - JAMAR© Hydraulic

    1 minute

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

    1 minute

  • PART 2: Age-specific refence values - Martin Vigorimeter

    1 minute

  • PART 2: Sex-specific refence values - JAMAR© Hydraulic

    0.5 minute

  • PART 2: Sex-specific refence values - JAMAR© Smart

    0.5 minute

  • +8 more secondary outcomes

Study Arms (3)

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: * JAMAR© Smart Dynamometer \[kg\] * JAMAR© Hydraulic Dynamometer \[kg\] * Martin Vigorimeter \[kPa\]

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: * JAMAR© Smart Dynamometer \[kg\] * JAMAR© Hydraulic Dynamometer \[kg\] * Martin Vigorimeter \[kPa\]

PART 2

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 \[KPa\]

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Balgrist

Zurich, Canton of Zurich, 8008, Switzerland

Location

Study Officials

  • Johannes Scherr, Prof Dr med

    Balgrist University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med. Johannes Scherr

Study Record Dates

First Submitted

October 2, 2022

First Posted

October 26, 2022

Study Start

November 17, 2022

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

February 11, 2025

Record last verified: 2025-02

Locations