Orthotics, Pain & Fear of Falling
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|ClinicalTrials.gov Identifier: NCT04894396|
Recruitment Status : Recruiting
First Posted : May 20, 2021
Last Update Posted : July 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Foot Pain Foot Functionality Fear of Falling||Device: Aetrex L2305 Premium Memory Foam Orthotics W/ Metatarsal Support Device: Aetrex L2300 Premium Memory Foam Orthotics||Not Applicable|
It is estimated that around 24% of community-dwelling adults over the age of 45 experience frequent foot pain. Falls and fear of falling are also significant issues in this population as both can result in avoidance of activities and decreased physical performance. In cases where fear of falling decreases physical performance and increases activity avoidance, it actually becomes a risk factor for falling itself.
Previous studies have shown that various types of Orthotic insoles improve balance and reduce lower-extremity pain in older adults. However, research which directly compares the effects of two different types of insoles is limited. Hence, this randomised control trial will investigate and compare the use of a prefabricated Orthotic, with and without a metatarsal pad, in decreasing pain and fear of falling in older adults.
This randomised control trial will be conducted over a 6-week period. The study population will include 206 participants who will be randomised into 2 groups (Group A and Group B). Participants in Group A will receive an Orthotic with a metatarsal pad and participants in Group B will receive a neutral Orthotic without the metatarsal pad. All participants will be required to continue with usual activities, using the Orthotic wherever possible for a period of 6 weeks. Participants will be asked to provide data in the form of completed surveys twice, once at the study onset and once at the end.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||206 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Control Trial Comparing Prefabricated Orthotics With and Without Metatarsal Pad in Decreasing Pain and Fear of Falling in Older Adults|
|Actual Study Start Date :||July 23, 2021|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Prefabricated Orthotics with metatarsal pad
Participants in Group A will receive the Orthotic with the metatarsal pad (L 2305) according to participants shoe size (https://www.aetrex.com/search?q=l2305&search-button=&lang=en_US). When the investigators provide the Orthotics, an instruction sheet will also be provided, explaining how to use the orthotic. Alternatively, an online video tutorial on how to use the Orthotic will also be available throughout the study. Participants will be required to use the Orthotic wherever possible for a period of 6 weeks, whilst continuing with usual activities.
Device: Aetrex L2305 Premium Memory Foam Orthotics W/ Metatarsal Support
An Orthotic insole to be inserted into shoes. Features Aetrex Arch Support to help biomechanically align the body & help prevent common foot pain such as Plantar Fasciitis, Arch Pain and Metatarsalgia. For medium to high arches with forefoot pain, featuring a cupped heel to cushion and stabilize the back of foot and a metatarsal pad to redistribute weight to relieve ball-of-foot discomfort. With 43% more memory foam in the forefoot for those experiencing foot discomfort or fatigue.
Active Comparator: Prefabricated Orthotics without metatarsal pad.
Participants in Group B will receive the neutral Orthotic with a cupped heel (L 2300) according to participants shoe size (https://www.aetrex.com/search?q=l2300&search-button=&lang=en_US). When the investigators provide the Orthotics, an instruction sheet will also be provided, explaining how to use the Orthotic. Alternatively, an online video tutorial on how to use the Orthotic will also be available throughout the study. Participants will be required to use the Orthotic wherever possible for a period of 6 weeks, whilst continuing with usual activities
Device: Aetrex L2300 Premium Memory Foam Orthotics
An Orthotic insole to be inserted into shoes. Features Aetrex Arch Support to help biomechanically align the body & help prevent common foot pain such as Plantar Fasciitis, Arch Pain and Metatarsalgia. With 43% more memory foam in the forefoot for those experiencing foot discomfort or fatigue.
- Changes in pain as assessed by a Visual Analogue Scale (VAS) [ Time Frame: Baseline and 6 weeks ]Pain scores will be collected using the Visual Analogue Scale (VAS) as follows: Levels of pain on a 0 to 10 scale with 0 representing no pain, 2 - mild pain, 5 - moderate pain, 7 - severe pain, and 10 represents extremely severe pain. Utilization of this scale is in line with previous research [and will measure pain in the feet, ankles, knees, hips, and lower back.
- Changes in foot pain & functionality as assessed by the Foot Health Status Questionnaire (FHSQ) [ Time Frame: Baseline and 6 weeks ]Foot Pain & Functionality scores will be collected using the FHSQ or Foot Health Status Questionnaire. The Foot Health Status Questionnaire is designed to assess foot pain, foot health and its relation to quality of life. The questionnaire has four domains consisting of 13 key items. The four domains are; foot pain, foot function, footwear and general foot health. The current study will only use the 2 subsections of Foot Pain and Foot Function. In these subsections, participants will be required to rate foot pain in the last week from 1 (none) to 5 (severe), how often the participant experienced different types of foot pain during the last week from 1 (never) to 5 (always), how much the participants feet interfered with everyday activities in the last week from 1 (not at all) to 5 (extremely) and overall foot health from 1 (excellent) to 5 (poor). Previous research has found the FHSQ to exhibit a strong degree of context, criterion and construct validity with high retest reliability.
- Fear of falling as assessed by the Falls Efficacy Scale International (FES-I) short. [ Time Frame: Baseline and 6 weeks ]Fear of falling will be measured using the Falls Efficacy Scale International (FES-I) short, The Falls Efficacy Scale-International (FES-I) (short) is a 7-item version of the FES-I. The questionnaire will ask participants to rate the concern about the possibility of falling when completing everyday tasks on a scale of 1 to 4 (where 1 = not at all concerned and 4 = very concerned). This version has been validated for community-dwelling older population. Furthermore, the short FES-I can predict future falls, muscle weakness, frailty and overall disability.
- Analysis of foot structure using the Gaitway scanner. [ Time Frame: Baseline ]All the participants would undergo analysis with the Gaitway scanner. The results of the scanner will only be documented for purposes of the study and the results of the scanning will not be used to determine the Orthotic the individual participant receives.
- Report how many hours, on average, the orthotics are worn each day. [ Time Frame: 6 weeks ]Participants will be required to report how many hours, on average, the Orthotics were worn each day <4 hours, 4 to 8 hours, > 8 hours.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04894396
|Contact: George Ampat, MBBS, MS, FRCSfirstname.lastname@example.org|
|Contact: Jonathan Sims, BScemail@example.com|
|Talita Cumi LTD.||Recruiting|
|Southport, Merseyside, United Kingdom, PR8 3NS|
|Contact: George Ampat, MBBS, MS, FRCS 07871 590593 firstname.lastname@example.org|
|Contact: Jonathan M Sims, BSc 01704808703 email@example.com|
|Principal Investigator: George Ampat, MBBS, MS, FRCS|
|Sub-Investigator: Jonathan Sims, BSc|
|Sub-Investigator: Benjamin Bradley|
|Sub-Investigator: Bertie Parkinson|
|Principal Investigator:||George Ampat, MBBS, MS, FRCS||Talita Cumi Ltd.|