Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000597897
Ethics application status
Approved
Date submitted
30/05/2012
Date registered
4/06/2012
Date last updated
28/08/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The rheumatoid foot and falls
Scientific title
Foot and ankle characteristics associated with falls and falls risk in people with rheumatoid arthritis
Secondary ID [1] 280589 0
Counties Manukau District Health Board research registration number 1220
Secondary ID [2] 280590 0
Auckland District Health Board research registration number A+5364
Universal Trial Number (UTN)
U1111-1131-2428
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
rheumatoid arthritis 286586 0
falls 286587 0
Condition category
Condition code
Inflammatory and Immune System 286862 286862 0 0
Rheumatoid arthritis
Public Health 286863 286863 0 0
Epidemiology
Injuries and Accidents 286896 286896 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
90 minutes clinical assessments at baseline and 12 months plus completion of a monthly falls diary for 12 months.
Intervention code [1] 284974 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287218 0
Falls history (no falls, 1 falls , more than 1 fall in preceding 12 months) - self-reported by participants
Timepoint [1] 287218 0
at baseline
Primary outcome [2] 287219 0
Prospectively determined falls (proportion of fallers; the proportion of multiple fallers; falling rate) participant self-reported using 12 month falls calendar / diary and standardised post fall interview
Timepoint [2] 287219 0
at 12 months after baseline
Secondary outcome [1] 297651 0
Foot deformity (bunions, claw/hammer toes, corns, calluses) using Foot Problem Score and Manchester Foot Disability Scale
Timepoint [1] 297651 0
at baseline and 12 months after baseline
Secondary outcome [2] 297652 0
Foot pain using 100mm Visual Analogue Scale
Timepoint [2] 297652 0
at baseline and 12 months after baseline
Secondary outcome [3] 297653 0
Plantar sensation using a biosthesiometer (vibration perception threshold) and 10g SW monofilament (fine touch)
Timepoint [3] 297653 0
at baseline and 12 months after baseline
Secondary outcome [4] 297654 0
Ankle range of motion using a goniometer
Timepoint [4] 297654 0
at baseline and 12 months after baseline
Secondary outcome [5] 297655 0
Foot and ankle muscle strength (inversion/eversion, dorsiflexion/plantarflexion) using a hand-held dynamometer
Timepoint [5] 297655 0
at baseline and 12 months after baseline
Secondary outcome [6] 297656 0
Hallux and lessor toe strength using the Paper Grip Test and a plantar pressure mat system
Timepoint [6] 297656 0
at baseline and 12 months after baseline
Secondary outcome [7] 297657 0
Plantar pressure (Peak Plantar Pressure and Pressure Time integral) using a plantar pressure mat system
Timepoint [7] 297657 0
at baseline and 12 months after baseline
Secondary outcome [8] 297658 0
Disability assessed using the Leeds Foot Impact Scale (LFIS), the Health Assessment Questionnaire-II (HAQII) and the Short Falls Efficacy Scale (FES-1).
Timepoint [8] 297658 0
at baseline and 12 months after baseline
Secondary outcome [9] 301781 0
Postural Sway (anterio-posterior and medio-lateral) using a plantar pressure mat system.
Timepoint [9] 301781 0
At baseline and 12 months after baseline
Secondary outcome [10] 301782 0
Indeitifcation of footwear worn to study visit and self-reported usual footwear indoors and usual footwear worn outside.
Timepoint [10] 301782 0
at baseline and 12 months after baseline
Secondary outcome [11] 301783 0
Self reported hearing impairment and hearing devices used
Timepoint [11] 301783 0
Baseline and 12 months after baseline
Secondary outcome [12] 301784 0
Identification of visual aids used
Timepoint [12] 301784 0
Baseline and at 12 months after baseline
Secondary outcome [13] 301785 0
Indentification of assistive devices used for walking (e.g. walker, cane)
Timepoint [13] 301785 0
Baseline and 12 months after baseline

Eligibility
Key inclusion criteria
Adults 18 years and older with diagnosed rheumatoid arthritis (according to ACR criteria) who can read, understand and sign the consent form
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under the age of 18 years, unable to read and understand the information sheet and unable to provide written informed consent.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2013
Actual
20/02/2013
Date of last participant enrolment
Anticipated
Actual
21/08/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
201
Recruitment outside Australia
Country [1] 4340 0
New Zealand
State/province [1] 4340 0
Auckland

Funding & Sponsors
Funding source category [1] 285345 0
Charities/Societies/Foundations
Name [1] 285345 0
Arthritis New Zealand
Country [1] 285345 0
New Zealand
Funding source category [2] 285346 0
Commercial sector/Industry
Name [2] 285346 0
Asics New Zealand
Country [2] 285346 0
New Zealand
Primary sponsor type
Individual
Name
Keith Rome
Address
Division of Rehabilitation & Occupation Studies
AUT University
Private Bag 92006
Auckland 1020
Country
New Zealand
Secondary sponsor category [1] 284196 0
Individual
Name [1] 284196 0
Nicola Dalbeth
Address [1] 284196 0
Department of Medicine
University of Auckland
Private Bag 92-019
Auckland 1142
Country [1] 284196 0
New Zealand
Other collaborator category [1] 276833 0
Individual
Name [1] 276833 0
Hylton Menz
Address [1] 276833 0
La Trobe University
Melbourne Victoria 3086
Country [1] 276833 0
Australia
Other collaborator category [2] 276834 0
Individual
Name [2] 276834 0
Sandra Bassett
Address [2] 276834 0
AUT University
Private Bag 92006
Auckland 1020
Country [2] 276834 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287359 0
Northern X Regional Ethics Committee
Ethics committee address [1] 287359 0
Private Bag 92522
Wellesley Street
Auckland 1141
New Zealand
Ethics committee country [1] 287359 0
New Zealand
Date submitted for ethics approval [1] 287359 0
Approval date [1] 287359 0
07/02/2012
Ethics approval number [1] 287359 0
NTX/11/12/114

Summary
Brief summary
People with rheumatoid arthritis (RA) have an increased risk of falling. Foot deformity is common in RA and may be linked to falls. The research will assess the relationship between foot deformity and falls in people with RA. Falls can result in death, injury, loss of confidence and independence and increased risk of falling. The identification of modifiable falls risk factors, in the rheumatoid foot, may lead to the development of an intervention that prevents falls in people with RA and improves quality of life.
Hypotheses to be tested:
1. There will be a significant difference in structural and functional foot and ankle characteristics in RA patients with a history of falls, compared to RA patients who have not fallen.
2. There will be an association found between foot and ankle characteristics and falls in patients with RA.
3. Specific foot and ankle characteristics, in the rheumatoid foot, will be identified as predictors of falls in patients with RA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34243 0
Mrs Angela Brenton-Rule
Address 34243 0
Division of Rehabilitation & Occupation Studies AUT University Private Bag 92006 Auckland 1020
Country 34243 0
New Zealand
Phone 34243 0
+64 9 5780121
Fax 34243 0
Email 34243 0
abrenton@aut.ac.nz
Contact person for public queries
Name 17490 0
Mrs Angela Brenton-Rule
Address 17490 0
Division of Rehabilitation & Occupation Studies
AUT University
Private Bag 92006
Auckland 1020
Country 17490 0
New Zealand
Phone 17490 0
+64 9 5780121
Fax 17490 0
Email 17490 0
abrenton@aut.ac.nz
Contact person for scientific queries
Name 8418 0
Prof Keith Rome
Address 8418 0
Division of Rehabilitation & Occupation Studies
AUT University
Private Bag 92006
Auckland 1020
Country 8418 0
New Zealand
Phone 8418 0
+64 9 921 9999
Fax 8418 0
+64 9 921 9839
Email 8418 0
krome@aut.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.