Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001033538p
Ethics application status
Submitted, not yet approved
Date submitted
12/08/2024
Date registered
27/08/2024
Date last updated
27/08/2024
Date data sharing statement initially provided
27/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Insole testing (biomechanics and pain rating)
Scientific title
Insole testing for biomechanics and pain rating by participants with foot, knee and back discomfort.
Secondary ID [1] 312737 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plantar fasciitis 334769 0
Diabetes 334770 0
Sore knees 334771 0
Sore back 334772 0
Condition category
Condition code
Musculoskeletal 331329 331329 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 331330 331330 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Insole for 6 weeks. 10 types of insoles. Three for plantar fasciitis, one for diabetes, one for knee pain, one for back pain, and four for general lower limb support.

- The type of insole will be selected based on the condition/ medical comorbidities (most conditions have only one insole option). For the conditions where there are more than one option, the participant gets to try on all options and self-select based on their rating of reducing pain and improving comfort (as they would do in a shop to make it relevant to the real life situation). The baseline assessments are then conducted in that insole of choice.
- Specific laboratory shoes will be used for the biomechanics and pressure analysis, plus the participants own shoes, for the pre and post testing. Only the participants shoes will be used for the 6 week intervention.
- The duration/frequency of insole wearing will be whenever participants wear shoes with the hours worn being recorded.
- The intervention will be administered by the research staff – i.e. podiatrists or biomechanists.
- The strategy used to monitor adherence to the intervention is a participant daily record sheet (hours insoles worn and VAS pain rating) with weekly reporting via RedCap.

The insole model numbers are: 20301 PLANTAR FASCIA Women
20302 PLANTAR FASCIA Men
21079 PLANTAR FASCIA ELITE Women
21080 PLANTAR FASCIA ELITE Men
20358 PLANTAR FASCIA SLEEVES Unisex
14759 DIABETIC Women
14758 DIABETIC Men
14339 ARCH SUPPORT COOKIE Unisex
13575 ARCH SUPPORT WRAPS Unisex
20406 FLAT FEET Women
20405 FLAT FEET Men
20225 COMFORT & SUPPORT Women
20224 COMFORT & SUPPORT Men
14755 LOWER BACK SUPPORT Women
14754 LOWER BACK SUPPORT Men
14757 KNEE SUPPORT Women
14756 KNEE SUPPORT Men
The duration of wear is at the participant's discretion but is recorded daily.
Intervention code [1] 329260 0
Treatment: Devices
Comparator / control treatment
No control. This is effect of the insole within each individual over the 6 weeks.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339087 0
Change in pain
Timepoint [1] 339087 0
T1 (baseline/pre-intervention), every week over 6 weeks, T2 (post-completion of intervention). T1 = day 1 in week 1. 6 weeks of intervention are weeks 2-7. T2 is in week 8. T2 is post-completion of intervention.
Primary outcome [2] 339088 0
Lower limb kinematics
Timepoint [2] 339088 0
T1 (pre-intervention) and T2 (post-completion of intervention).
Secondary outcome [1] 438502 0
Walking time
Timepoint [1] 438502 0
T1 (pre-intervention) and T2 (post-completion of intervention).
Secondary outcome [2] 438503 0
Plantar pressure
Timepoint [2] 438503 0
T1 (pre-intervention) and T2 (post-completion of intervention).

Eligibility
Key inclusion criteria
Inclusion Criteria
- Age: Participants aged 18-65 years.
- Ethnicity: Any
- Individuals with specific health conditions relevant to the study (i.e. heel pain, knee or back pain).
- individuals with flat feet.
- Residents of the Auckland region to facilitate follow-up and community engagement.
Willingness to Participate:
- Participants must be willing to attend the two data collection sessions and wear the insole over 6 weeks.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria
- Individuals with severe comorbidities that could interfere with the study outcomes (e.g., severe cardiovascular disease).
- Individuals who are unable to provide informed consent due to cognitive impairments or language barriers.
- Participants who are physically unable to complete a 2 or 6-minute walk.
- Individuals who currently wear foot orthoses, or non-standard insoles

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
A G*Power analysis for a one-tailed paired-samples t-test indicated that the minimum sample size to yield a statistical power of at least 0.8 with an alpha of 0.05 and a medium effect size of 0.5 is 27. On a 10-point pain scale, effect sizes are interpreted using Cohen's thresholds. Typically, a small effect size is around 0.2 standard deviations. For a 10-point pain scale, where the standard deviation is usually about 2 points, this translates to a change of approximately 0.4 points. We will evaluate a single orthotic intervention per subject using the subjects’ own shoes. Factor 1 is the or-thotic (independent subject pools, n=27 per orthotic condition). Factor 2: Pre- and post- period of intervention (repeated measures on same participants). The statistical model is a One-way analysis of variance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2024
Actual
Date of last participant enrolment
Anticipated
4/10/2024
Actual
Date of last data collection
Anticipated
9/12/2024
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment outside Australia
Country [1] 26503 0
New Zealand
State/province [1] 26503 0
Auckland

Funding & Sponsors
Funding source category [1] 317170 0
Commercial sector/Industry
Name [1] 317170 0
Implus
Country [1] 317170 0
United States of America
Primary sponsor type
University
Name
Auckland University of Technology
Address
Country
New Zealand
Secondary sponsor category [1] 319433 0
None
Name [1] 319433 0
Address [1] 319433 0
Country [1] 319433 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315914 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 315914 0
Ethics committee country [1] 315914 0
New Zealand
Date submitted for ethics approval [1] 315914 0
08/08/2024
Approval date [1] 315914 0
Ethics approval number [1] 315914 0

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

Contacts
Principal investigator
Name 136202 0
Prof Patria Hume
Address 136202 0
Auckland University of Technology, AUT Millennium, 17 Antares Place, Mairangi Bay; Private Bag 92006, Auckland 1142, New Zealand
Country 136202 0
New Zealand
Phone 136202 0
+64 021805591
Fax 136202 0
Email 136202 0
[email protected]
Contact person for public queries
Name 136203 0
Patria Hume
Address 136203 0
Auckland University of Technology, AUT Millennium, 17 Antares Place, Mairangi Bay; Private Bag 92006, Auckland 1142, New Zealand
Country 136203 0
New Zealand
Phone 136203 0
+64 021805591
Fax 136203 0
Email 136203 0
[email protected]
Contact person for scientific queries
Name 136204 0
Patria Hume
Address 136204 0
Auckland University of Technology, AUT Millennium, 17 Antares Place, Mairangi Bay; Private Bag 92006, Auckland 1142, New Zealand
Country 136204 0
New Zealand
Phone 136204 0
+64 021805591
Fax 136204 0
Email 136204 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants are advised that no individual data will be reported.


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.