NCT02026245

Brief Summary

In this study we will compare two electronic goniometric gloves to see if they can be used in research on joint movement in arthritis. One of the gloves we will use is the commercially available '5DT Ultra 14 glove', the other is a glove that we have specially designed and developed for use in people with arthritis. Both gloves are 'high-end' gloves with sensors for all of the finger and thumb joints. We aim to find out if the gloves are accurate and if they can be worn and used without too much discomfort by people with arthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable rheumatoid-arthritis

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 1, 2014

Completed
2.6 years until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

1.1 years

First QC Date

December 5, 2013

Last Update Submit

November 4, 2020

Conditions

Rheumatoid Arthritis

Keywords

Arthritisrheumatoidjointsswellingmeasurementmovementelectronicdataglovegoniometryoutcomestiffness

Outcome Measures

Primary Outcomes (1)

  • The accuracy of joint angle measurement by each electronic goniometric glove will be compared with the accuracy of manual goniometry.

    The standard error of measurement for each electronic goniometric glove will be used to evaluate the reliability of each electronic goniometric glove. This will be compared to the standard error of measurement for manual goniometry.

    1 day

Secondary Outcomes (9)

  • The variability in the measurement of joint movement velocity

    1 day

  • Variability of joint angle measurements by the electronic goniometric gloves will be assessed

    1 day

  • The number of patients who withdraw or refuse to continue

    1 day

  • Variation in joint angle movement between fit and refit

    1 day

  • Variation in joint angle measurement across the range of movement

    1 day

  • +4 more secondary outcomes

Study Arms (2)

5DT electronic data glove

EXPERIMENTAL

Using the electronic data gloves to perform a set routine of movements. Intervention: Data gloves to perform movements

Device: Data gloves to perform movements

Tyndall/UU electronic data glove

EXPERIMENTAL

Using the electronic data gloves to perform a set routine of movements Intervention: Data gloves to perform movements

Device: Data gloves to perform movements

Interventions

Data gloves to perform movementsDEVICE

Using the electronic data gloves to perform a set routine of movements: * 5DT 'dataglove 14 Ultra' Electronic glove (commercially available) * New 'Tyndall/UU' developmental dataglove

Also known as: 5DT, Tyndall/UU dataglove
5DT electronic data gloveTyndall/UU electronic data glove

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients aged 18 to 80
  • Diagnosis of Rheumatoid arthritis
  • Patients who have significant pain and stiffness in their hands
  • Correct hand size to achieve a good fit to the electronic goniometric glove

You may not qualify if:

  • Poor fit for the disposable surgical glove
  • Severe pain in the right hand
  • Severe swelling in the right hand (rated as such by the investigator)
  • Major permanent deformities in the right hand
  • Active hyperextension \>30 degrees in any joint of the right hand
  • Broken or infected skin in the right hand
  • Known to have tested positive for Methicillin resistant staphylococcus aureus (MRSA) skin infections in the past
  • Unable to don the lining disposable glove without significant discomfort
  • History of Latex allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Health and Social Care Trust

Londonderry, BT47 1SB, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Philip Gardiner, MB BCh MD

    WHSCT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

December 5, 2013

First Posted

January 1, 2014

Study Start

August 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

November 6, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

IPD may be considered available at a later date, anonymised.

Locations

GB(1)