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Trial registered on ANZCTR


Registration number
ACTRN12616000230459
Ethics application status
Approved
Date submitted
11/02/2016
Date registered
19/02/2016
Date last updated
1/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of a stretching intervention in lowering plantar pressures related to reduced ankle range of motion in people with diabetes.
Scientific title
The effectiveness of a stretching intervention in lowering plantar pressures related to reduced ankle range of motion in people with diabetes.
Secondary ID [1] 288495 0
none
Universal Trial Number (UTN)
U1111-1179-3343
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 297555 0
Foot plantar pressure 297556 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297757 297757 0 0
Other physical medicine / rehabilitation
Metabolic and Endocrine 297826 297826 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
8 week home based stretching program.
The stretching program will consist of a standing static lunge calf stretch, which will be held for 30 seconds and repeated 4 times on each leg during each session. Participants will be required to perform one stretching session per day, five days a week, for the eight week trial period.
Participants will complete a daily stretch diary to record how often they did the stretches.
Intervention code [1] 293857 0
Prevention
Intervention code [2] 293858 0
Treatment: Other
Comparator / control treatment
The control group will undertake their usual activities for the intervention period
Control group
Active

Outcomes
Primary outcome [1] 297286 0
Peak pressure under defined areas of the foot (e.g. forefoot, midfoot, heel) measured in-shoe using the pedar-x system with flexible insoles, and measured barefoot using the Tekscan HR mat pressure platform.
Timepoint [1] 297286 0
8 weeks and 16 weeks following baseline
Primary outcome [2] 297287 0
Ankle dorsiflexion range of motion measured in:
- weightbearing using a weight-bearing lunge position, with knee extended and a digital inclinometer,
- non weightbearing using a modified Lidcombe template, with a force gauge and a digital inclinometer, which allows a standardised magnitude and direction of force to be applied to the ankle.
Timepoint [2] 297287 0
8 weeks and 16 weeks following baseline
Secondary outcome [1] 320623 0
Pressure-time integrals under defined areas of the foot (e.g. forefoot, midfoot, heel, etc) measured in-shoe using the pedar-x system with flexible insoles, and measured barefoot using the Tekscan HR mat pressure platform.
Timepoint [1] 320623 0
8 weeks and 16 weeks following baseline
Secondary outcome [2] 320624 0
Peak force under defined areas of the foot (e.g. forefoot, midfoot, heel, etc) measured in-shoe using the pedar-x system with flexible insoles, and measured barefoot using the Tekscan HR mat pressure platform.
Timepoint [2] 320624 0
8 weeks and 16 weeks following baseline
Secondary outcome [3] 320625 0
Contact area under defined areas of the foot (e.g. forefoot, midfoot, heel, etc) measured in-shoe using the pedar-x system with flexible insoles, and measured barefoot using the Tekscan HR mat pressure platform.
Timepoint [3] 320625 0
8 weeks and 16 weeks following baseline
Secondary outcome [4] 320626 0
Contact time under defined areas of the foot (e.g. forefoot, midfoot, heel, etc) measured in-shoe using the pedar-x system with flexible insoles, and measured barefoot using the Tekscan HR mat pressure platform.
Timepoint [4] 320626 0
8 weeks and 16 weeks following baseline
Secondary outcome [5] 320627 0
Physical activity as measured by International Physical Activity Questionnaire Short Form (IPAQ-SF)
Timepoint [5] 320627 0
8 weeks and 16 weeks following baseline

Eligibility
Key inclusion criteria
a) reduced ankle dorsiflexion range of motion (equinus) defined as ankle dorsiflexion range of motion of less than or equal to five degrees
b) males and females 18 years of age and over
c) with a diagnosis of diabetes confirmed by medical records
d) able to speak and read basic English
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) current foot ulcer
b) any amputation in the lower limb
c) any self-reported neurological condition (other than loss of sensation due to diabetes) that
may affect the lower limb such as multiple sclerosis, stroke or polio
d) surgery to the foot or lower limb involving fixation of a joint
e) any condition precluding the participant from taking part in the foot pressure assessment
or ankle stretching program, such as not being able to walk 8m unaided
f) pregnancy

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)
By selection of sequentially numbered, opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer generated random allocation schedule
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
To determine the effect of an eight week calf stretching program on the primary outcome of ankle dorsiflexion range of motion, and to allow statistical analysis to determine participant factors correlated with an increase in ankle dorsiflexion, a minimum sample size of 34 per group will be required for the randomised controlled trial.
The calculations are based on the following assumptions:
1) an SD of 6.5 degrees and difference of 5 degrees between the control group and the experimental group being clinically meaningful;
2) a power of 0.80 and alpha of 0.05 and;
3) a 20% attrition rate.
All data will be explored for normality prior to inferential analysis. One-way analysis of variance (ANOVA) with Bonferroni-adjusted post-hoc tests will be used to compare pressure measurements under various sites of the foot between the two test groups before and after the stretching program.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 292854 0
University
Name [1] 292854 0
University of Newcastle
Address [1] 292854 0
School of Health Sciences
PO Box 127
Ourimbah, NSW 2258
Country [1] 292854 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
School of Health Sciences
PO Box 127
Ourimbah, NSW 2258
Country
Australia
Secondary sponsor category [1] 291598 0
None
Name [1] 291598 0
Address [1] 291598 0
Country [1] 291598 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294354 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 294354 0
The Chancellery
University of Newcastle Callaghan Campus
University Drive
Callaghan NSW 2308
Ethics committee country [1] 294354 0
Australia
Date submitted for ethics approval [1] 294354 0
18/09/2015
Approval date [1] 294354 0
21/12/2015
Ethics approval number [1] 294354 0
H-2015-0354

Summary
Brief summary
Diabetes is one of the most common chronic diseases in the world, affecting over 8% of the
global population and is associated with a life-time risk of foot ulcers of 12-25%. Foot ulcers
lead to high morbidity, increased associated healthcare costs and are the most important risk factor for lower extremity amputation. Elevated forefoot plantar pressure is a risk factor for foot ulceration and has been linked to reduced ankle dorsiflexion range of motion (equinus) in people with diabetes.

Calf muscle stretching has been demonstrated to improve ankle joint range of motion across both the young and older adult healthy populations, and a pilot trial has demonstrated a reduction in plantar pressures following range of motion exercises in people with diabetes.

Calf muscle stretching may be a simple, non-invasive and inexpensive method of increasing ankle joint range of motion resulting in decreased plantar pressures and a reduced risk of plantar ulceration in people with diabetes.

The aims of this trial are
1) To determine if an 8 week calf stretching intervention will be effective in increasing ankle joint range of motion in people with diabetes and ankle equinus.
2) To determine if an increased ankle joint range of motion in people with diabetes and ankle equinus results in an associated reduction in forefoot plantar pressures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63374 0
A/Prof Vivienne H Chuter
Address 63374 0
University of Newcastle
School of Health Sciences
PO Box 127
Ourimbah, NSW 2258
Country 63374 0
Australia
Phone 63374 0
+ 61 2 4349 4424
Fax 63374 0
Email 63374 0
vivienne.chuter@newcastle.edu.au
Contact person for public queries
Name 63375 0
A/Prof Vivienne H Chuter
Address 63375 0
University of Newcastle
School of Health Sciences
PO Box 127
Ourimbah, NSW 2258
Country 63375 0
Australia
Phone 63375 0
+ 61 2 4349 4424
Fax 63375 0
Email 63375 0
vivienne.chuter@newcastle.edu.au
Contact person for scientific queries
Name 63376 0
A/Prof Vivienne H Chuter
Address 63376 0
University of Newcastle
School of Health Sciences
PO Box 127
Ourimbah, NSW 2258
Country 63376 0
Australia
Phone 63376 0
+ 61 2 4349 4424
Fax 63376 0
Email 63376 0
vivienne.chuter@newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary