RecruitingACTRN12624001033538

Insole testing (biomechanics and pain rating)

Insole testing for biomechanics and pain rating by participants with foot, knee and back discomfort.


Sponsor

Auckland University of Technology

Enrollment

100 participants

Start Date

Sep 3, 2024

Study Type

Interventional

Conditions

Summary

Insoles are commonly used to improve foot function, alleviate pain, and enhance comfort. Understanding their impact on lower limb biomechanics, foot pressure distribution, and self-reported pain and comfort is crucial for optimizing their design and application. Therefore, the aim of the study is to assess how the insoles in question affect lower limb biomechanics, foot pressure, and self-reported pain and comfort.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

Shoe insoles are widely used to relieve foot, knee, and back pain and to improve how the foot moves during walking, but more research is needed on exactly how different insole designs affect the body's movement and people's experience of pain and comfort. This study is testing a specific set of insoles to measure their effect on lower limb movement, pressure distribution under the foot, and self-reported pain and comfort levels. Participants will attend two data collection sessions and wear the insoles for six weeks, during which changes in movement and pain will be assessed. The study uses motion capture and pressure-measuring equipment during walking tasks to capture detailed biomechanical information. You may be eligible if you are aged 18 to 65, live in the Auckland region, and have heel pain, knee pain, back pain, or flat feet. Participants must be willing to attend both testing sessions and wear the insoles consistently for six weeks. People with severe cardiovascular disease, who are unable to walk for two to six minutes, who have a cognitive impairment preventing consent, or who currently wear custom orthotics or non-standard insoles are not eligible. The study is run in New Zealand.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 s

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.


Locations(1)

Auckland, New Zealand

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ACTRN12624001033538


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