Digitized Grip Strength

NCT ID: NCT02197507

Last Updated: 2014-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-12-31

Brief Summary

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Rheumatoid arthritis (RA) is the most common chronic inflammatory arthritis in adults. Monitoring of disease activity is based on Disease Activity Score 28 (DAS 28). There are also validated questionnaires for self-assessment of the disease by the patient. Grip strength measured using a digitized sensor used by the patient could be an additional tool to the remote monitoring of patients with RA.

Main Objective : To evaluate the correlation between the measurement of grip strength in the dominant hand measured by a digital sensor and activity of RA assessed by DAS 28

Secondary objective : Evaluate the correlation between grip strength of the dominant hand and :

* scores of fatigue and pain (VAS and FACIT)
* the self-assessment scores known in RA : functional index Health Assessment Questionnaire (HAQ) and scores of activity RAPID3 and RADAI5.

It is a cross-sectional study involving 150 patients followed in our department for RA. Grip strength of the dominant hand will be measured by a digitalized sensor during a single visit integrating into the routine monitoring of patients.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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RA patients

Group Type EXPERIMENTAL

Digitized sensor

Intervention Type DEVICE

Measure of grip strength of the dominant hand

Interventions

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Digitized sensor

Measure of grip strength of the dominant hand

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Rheumatoid arthritis whatever its activity
* Above 18 years old patients

Exclusion Criteria

* Other condition that may affect the level of fatigue and / or grip strength
* Insufficient level of understanding to perform the measurement and self-report questionnaires
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UH Montpellier

Montpellier, , France

Site Status

Countries

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France

Central Contacts

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Christian Jorgensen, MD

Role: CONTACT

04 67 33 72 31

Facility Contacts

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Christian Jorgensen, MD

Role: primary

04 67 33 72 31

Other Identifiers

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9385

Identifier Type: -

Identifier Source: org_study_id

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