Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000065392
Ethics application status
Approved
Date submitted
31/01/2008
Date registered
6/02/2008
Date last updated
27/10/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Podiatry treatment to improve
balance and prevent falls in older people
Scientific title
Randomised controlled trial of a multifactorial podiatry intervention to improve balance and prevent falls in older
people
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls in older people (over 65 years). 2761 0
Foot pain in older people (over 65 years). 2763 0
Balance in older people (over 65 years). 2762 0
Condition category
Condition code
Physical Medicine / Rehabilitation 2891 2891 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention consists of footwear, orthoses, exercise and general podiatric care:
The study runs for 1 year from baseline assessment.
All interventions will be for 1 year except for the exercise program which is for 6 months.

(i) Footwear - assessment of current footwear, and if required, financial assistance in purchasing footwear more appropriate footwear

(ii) Orthoses - customised insoles of preformed EVA insoles with poron padding to accommodate plantar lesions

(iii) Home based exercise program consisting of stretching exercises for the ankle and 1st metatarsophalangeal joints and strengthening exercises for the ankle and toe plantarflexor muscles. The exercise program will be performed three times a week for 6 months (from baseline to follow up assessment). The program will be 30 minutes long with approxiamtely 20 minutes of strengthening and 10 minutes of stretching.

(iv) General podiatric care consisting of nail trimming and callus and corn reduction every 8 weeks for 1 year
Intervention code [1] 2501 0
Prevention
Comparator / control treatment
"Usual care" - general podiatric care consisting of nail trimming and callus and corn reduction every 8 weeks for 1 year.
Control group
Active

Outcomes
Primary outcome [1] 3773 0
The proportion of fallers in each group
Timepoint [1] 3773 0
12 months after baseline assessment
Primary outcome [2] 3774 0
The proportion of multiple fallers (i.e. those who fell 2 or more times) in each group.
Timepoint [2] 3774 0
12 months after baseline assessment
Primary outcome [3] 3775 0
The falling rate (falls per person expressed relative to duration of follow-up) in each group
Timepoint [3] 3775 0
12 months after baseline assessment
Secondary outcome [1] 6376 0
Clinical measures of balance(coordinated stability, maximum balance range and postural sway)
Timepoint [1] 6376 0
At baseline and 6 months
Secondary outcome [2] 6375 0
Foot pain score using the Manchester Foot Pain and Disability Index (MFDPI)
Timepoint [2] 6375 0
At baseline and 6 months
Secondary outcome [3] 6374 0
Time to first fall
Timepoint [3] 6374 0
12 months after baseline assessment

Eligibility
Key inclusion criteria
1. Age = 65 years.
2. Elevated risk of falling (defined as either a history of previous falls or a score of > 1 on the Physiological Profile Assessment)
3.Self-reported disabling foot pain (defined as people who have current foot pain, foot pain lasting for at least one month, and a positive response to at least one item on the Manchester Foot Pain and Disability Index (MFDPI).
4. Able to walk household distances without the use of a walking aid
5. Able to read and speak basic English
6. Cognitively intact (defined as a score of > 7 on the Short Portable Mental Status Questionnaire).
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Lower limb amputation (including partial foot amputation)
2. Parkinson’s disease
3. Active plantar ulceration
4. Cognitive impairment

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruitment via mailout to clients at the La Trobe University podiatry clinic, Melbourne, Victoria.
Allocation after initial baseline assessment using external telephone randomisation service
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation via external telephone randomisation service.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 560 0
3086

Funding & Sponsors
Funding source category [1] 3015 0
Government body
Name [1] 3015 0
National Health & Medical Research Council
Country [1] 3015 0
Australia
Primary sponsor type
Individual
Name
Dr Hylton Menz
Address
La Trobe University,
Kinsbury Drive,
Bundoora
Victoria, 3086
Country
Australia
Secondary sponsor category [1] 2720 0
Individual
Name [1] 2720 0
Dr Karl Landorf
Address [1] 2720 0
La Trobe University, Bundoora, Victoria 3086, Australia
Country [1] 2720 0
Australia
Secondary sponsor category [2] 2721 0
Individual
Name [2] 2721 0
Prof Keith Hill
Address [2] 2721 0
La Trobe University,
Kinsbury Drive,
Bundoora
Victoria, 3086
Country [2] 2721 0
Australia
Secondary sponsor category [3] 2722 0
Individual
Name [3] 2722 0
Prof Stephen Lord
Address [3] 2722 0
Prince of Wales Medical Research Institute
Cnr Barker Street & Easy Street
Randwick Australia 2031
Country [3] 2722 0
Australia
Secondary sponsor category [4] 2723 0
Individual
Name [4] 2723 0
Martin Spink
Address [4] 2723 0
La Trobe University,
Kinsbury Drive,
Bundoora
Victoria, 3086
Country [4] 2723 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4971 0
La Trobe University Human Ethics committee
Ethics committee address [1] 4971 0
Ethics committee country [1] 4971 0
Australia
Date submitted for ethics approval [1] 4971 0
Approval date [1] 4971 0
12/10/2007
Ethics approval number [1] 4971 0
07-118

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28327 0
Address 28327 0
Country 28327 0
Phone 28327 0
Fax 28327 0
Email 28327 0
Contact person for public queries
Name 11484 0
Dr Hylton Menz
Address 11484 0
La Trobe University,
Kinsbury Drive,
Bundoora
Victoria, 3086
Country 11484 0
Australia
Phone 11484 0
(03) 9479 5801
Fax 11484 0
Email 11484 0
h.menz@latrobe.edu.au
Contact person for scientific queries
Name 2412 0
Dr Hylton Menz
Address 2412 0
La Trobe University,
Kinsbury Drive,
Bundoora
Victoria, 3086
Country 2412 0
Australia
Phone 2412 0
(03) 9479 5801
Fax 2412 0
Email 2412 0
h.menz@latrobe.edu.au

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.