Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001030066
Ethics application status
Approved
Date submitted
22/11/2010
Date registered
23/11/2010
Date last updated
5/09/2024
Date data sharing statement initially provided
5/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Stretching to improve flexibility and reduce pressure under the feet in adolescents with diabetes
Scientific title
Stretching in adolescents with diabetes to improve flexibility and reduce plantar pressure under the feet
Secondary ID [1] 253078 0
Nil
Universal Trial Number (UTN)
U1111-1117-9527
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes 258643 0
limited joint mobility and high plantar pressures 258645 0
Condition category
Condition code
Musculoskeletal 258781 258781 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 258852 258852 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group 1
20 minutes of static stretching for the ankle joint and the great toe. Stretches to be performed at the end range of motion 3 times a week for 6 weeks
Intervention group 2
20 minutes of dynamic stretches through the range of motion of the ankle joint and the great toe. Stretches to be performed 3 times a week for 6 weeks.
Intervention code [1] 257599 0
Prevention
Intervention code [2] 257655 0
Treatment: Other
Comparator / control treatment
Control group (no treatment)
No stretching intervention will be provided for the period of the trial.
Control group
Active

Outcomes
Primary outcome [1] 259648 0
A reduction of peak plantar pressure of 10 N/cm2 at the foot. Peak pressure will be measured with the Pedar-X mobile in-shoe plantar pressure system (Novel gmbh, Munich, Germany). The Pedar-X is the gold standard in plantar pressure assessment in diabetes and is non-invasive.
Timepoint [1] 259648 0
Baseline
Day one after intervention
Six- weeks after intervention
Secondary outcome [1] 266310 0
An increase of 10 degrees of range of motion of the ankle and big toe joints. Range of motion, will be measured using standardised clinical measurement procedures with degrees of motion read from a goniometer. A standardised lunge test will also be used to measure ankle joint range with a goniometer, and a ruler to measure distance of the foot from the wall.
Timepoint [1] 266310 0
Baseline
Day one after intervention
Six- weeks after intervention

Eligibility
Key inclusion criteria
adolescents with diabetes of at least one year duration
Minimum age
13 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major musculoskeletal problems which result in atypical walking patterns, the use of walking aids and
previous ulcerations. Back injuries/ pain and neurological deficiencies in the foot were stretching may be
contraindicated

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)
Sealed opaque envelopes will be used for concealed allocation so that the person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, and to which group the subject is allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
2/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
57
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258046 0
University
Name [1] 258046 0
Seed grant scheme: University of Western Sydney
Country [1] 258046 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
School Of Biomedical and Health Sciences
Locked bag 1797
Penrith South DC NSW 1797
Country
Australia
Secondary sponsor category [1] 257235 0
Individual
Name [1] 257235 0
Dr Stefania Penkala
Address [1] 257235 0
University of Western Sydney
School Of Biomedical and Health Sciences
Locked bag 1797
Penrith South DC NSW 1797
Country [1] 257235 0
Australia
Other collaborator category [1] 251652 0
Individual
Name [1] 251652 0
Dr Julia Bowman
Address [1] 251652 0
University of Western Sydney
School Of Biomedical and Health Sciences
Locked bag 1797
Penrith South DC NSW 1797
Country [1] 251652 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260045 0
University of Western Sydney Human Research Ethics Committee (EC00314)
Ethics committee address [1] 260045 0
University of Western Sydney Human Research Ethics Locked bag 1797
Penrith South DC NSW 1797
Ethics committee country [1] 260045 0
Australia
Date submitted for ethics approval [1] 260045 0
Approval date [1] 260045 0
22/11/2010
Ethics approval number [1] 260045 0
H8729

Summary
Brief summary
Adolescents with diabetes display limited joint mobility. Because of the association with high pressures under the feet, poor sensation and foot ulceration with disease progression, limited joint mobility assessment is a standard procedure in diabetic foot care. Clinical interventions to
reduce high pressures under the feet include orthoses, footwear and surgical correction. While stretching
has been reported to improve ankle joint range of motion in the general population, limited evidence is available for individuals with diabetes. The evidence for calf stretching in
adolescents where prevention of contractures and high plantar pressures in the early stages of disease may be most beneficial have not been investigated. This study will use a randomised control study to investigate the efficacy of stretching on the ankle and big toe joints to reduce high pressures under the feet and contractures of the ankle and foot joints.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31908 0
Address 31908 0
Country 31908 0
Phone 31908 0
Fax 31908 0
Email 31908 0
Contact person for public queries
Name 15155 0
Stefania Penkala
Address 15155 0
University of Western Sydney
School of Biomedical and Health Sciences
Sciences. Campbelltown Campus,
Bld 24. Locked bag 1797
Penrith South DC NSW 1797
Country 15155 0
Australia
Phone 15155 0
+61 2 46203742
Fax 15155 0
+61 2 46203792
Email 15155 0
[email protected]
Contact person for scientific queries
Name 6083 0
Stefania Penkala
Address 6083 0
University of Western Sydney
School of Biomedical and Health Sciences
Sciences. Campbelltown Campus,
Bld 24. Locked bag 1797
Penrith South DC NSW 1797
Country 6083 0
Australia
Phone 6083 0
+61 2 46203742
Fax 6083 0
+61 2 46203792
Email 6083 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.