Gripwise® Versus JAMAR® | NCT05060874

Studies
Gripwise® Versus JAMAR®

NCT05060874

Sponsor

University Hospital, Caen

Status

Completed

Last Update Posted

Nov 30, 2021Actual

Enrollment

348Actual

Phase

Not provided

Conditions

Age-Related Sarcopenia

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Actual

Primary Completion Date

Sep 1, 2021Actual

Completion Date

Nov 18, 2021Actual

First Submitted Date

Sep 22, 2021

First Submission Date that Met QC Criteria

Sep 22, 2021

First Posted Date

Sep 29, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2021

Last Update Posted Date

Nov 30, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

It is recommended to screen ageing patients for sarcopenia, due to the increased risk of morbimortality if detected positive. According to the consensus of the European Working Group on Sarcopenia in Older People, the diagnosis of sarcopenia is based, among other things, on grip strength measurement.

Our study will compare the performance of the new GRIPWISE digital device with the mechanical dynamometer JAMAR, the gold standard currently used to assess the grip strength. We propose to evaluate it in an elderly hospitalized population where the prevalence of sarcopenia is likely to be high due to the high prevalence of various chronic illness, notably oncological and cardiological ones.

This cross-sectional study will include 348 patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

348Actual

Label	Type	Description	Intervention Names
single group		gripwise or jamar will be randomly assessed first

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison between Jamar® and Gripwise® values for grip strength measurement	Intra-class correlation between the best values obtained with each device	day1

Secondary Outcomes

Measure	Description	Time Frame
comparison according to the patient's position	correlations of dynamometer measurements between patients assessed in the sitting or lying position	day1
number of attempt to reach the maximum value

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

men and women aged 65 or over
affiliated to a health insurance
Francophone.

Exclusion Criteria:

- refusal to participate
unable to communicate
unable to use both hands (dominant and non-dominant)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

aged inpatients hospitalized in CAEN University Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bérengère Beauplet, MD	Caen UH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Caen University Hospital		Caen			France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jul 8, 2024
Reset	Oct 15, 2024