None listed
Conditions
Brief 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.
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 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 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.
Sponsors
Auckland University of Technology
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
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
Outcome results
None listed