Digitized Grip Strength

• Sponsor: University Hospital, Montpellier (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02197507
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arm: 1
• Duration (Months): 15
• Patients Per Site Per Month: 10

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Device: Digitized sensor	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Evaluation of Grip Strength With Digitized Sensor in Adults With Rheumatoid Arthritis
• Study Start Date: Sep 1, 2014
• Anticipated Primary Completion Date: Sep 1, 2015
• Anticipated Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RA patients	Device: Digitized sensor; Measure of grip strength of the dominant hand

Outcome Measures

Primary Outcome Measures

1. grip strength [visit 1]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UH Montpellier	Montpellier		France	34295

Sponsors and Collaborators

• University Hospital, Montpellier

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT02197507
• Other Study ID Numbers: 9385
• First Posted: Jul 22, 2014
• Last Update Posted: Jul 22, 2014
• Last Verified: Jul 1, 2014

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

No Results Posted as of Jul 22, 2014