Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
206 participants
INTERVENTIONAL
2021-07-23
2023-01-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Orthotics and Running
NCT04901442
Plantar Fasciitis and the Use of Orthotics as Treatment
NCT04894383
Effects of Prefabricated Foot Orthoses With and Without Metatarsal Pads on Central Metatarsalgia
NCT06350435
AS: Ankle Spacer for Talar Osteochondral Defects
NCT03303690
Analyzing Orthopedic Patient Experience Patterns in Medical Trials
NCT05483673
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Live in a community-based setting
* Are capable of ambulation
* Have some form of self-identified foot pain
Exclusion Criteria
* Peripheral neuropathy and lack of sensation in the feet.
* Previous history of foot surgery and
* Inability to follow the instructions and procedures of the research protocol.
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aetrex Worldwide Inc
INDUSTRY
Talita Cumi Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
George Ampat, MBBS, MS, FRCS
Role: PRINCIPAL_INVESTIGATOR
Talita Cumi Ltd.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Talita Cumi LTD.
Southport, Merseyside, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Menz HB. Chronic foot pain in older people. Maturitas. 2016 Sep;91:110-4. doi: 10.1016/j.maturitas.2016.06.011. Epub 2016 Jun 22.
Verma SK, Willetts JL, Corns HL, Marucci-Wellman HR, Lombardi DA, Courtney TK. Falls and Fall-Related Injuries among Community-Dwelling Adults in the United States. PLoS One. 2016 Mar 15;11(3):e0150939. doi: 10.1371/journal.pone.0150939. eCollection 2016.
Schoene D, Heller C, Aung YN, Sieber CC, Kemmler W, Freiberger E. A systematic review on the influence of fear of falling on quality of life in older people: is there a role for falls? Clin Interv Aging. 2019 Apr 24;14:701-719. doi: 10.2147/CIA.S197857. eCollection 2019.
Bennett PJ, Patterson C. The foot health status questionnaire (FHSQ): a new instrument for measuring outcomes of foot care. Australasian J Podiatr Med. 1998;32:55-9
Kempen GI, Yardley L, van Haastregt JC, Zijlstra GA, Beyer N, Hauer K, Todd C. The Short FES-I: a shortened version of the falls efficacy scale-international to assess fear of falling. Age Ageing. 2008 Jan;37(1):45-50. doi: 10.1093/ageing/afm157. Epub 2007 Nov 20.
Thomas MJ, Roddy E, Zhang W, Menz HB, Hannan MT, Peat GM. The population prevalence of foot and ankle pain in middle and old age: a systematic review. Pain. 2011 Dec;152(12):2870-2880. doi: 10.1016/j.pain.2011.09.019. Epub 2011 Oct 21.
Roddy E, Muller S, Thomas E. Onset and persistence of disabling foot pain in community-dwelling older adults over a 3-year period: a prospective cohort study. J Gerontol A Biol Sci Med Sci. 2011 Apr;66(4):474-80. doi: 10.1093/gerona/glq203. Epub 2010 Nov 24.
White EG, Mulley GP. Footcare for very elderly people: a community survey. Age Ageing. 1989 Jul;18(4):276-8. doi: 10.1093/ageing/18.4.275.
Friedman SM, Munoz B, West SK, Rubin GS, Fried LP. Falls and fear of falling: which comes first? A longitudinal prediction model suggests strategies for primary and secondary prevention. J Am Geriatr Soc. 2002 Aug;50(8):1329-35. doi: 10.1046/j.1532-5415.2002.50352.x.
Mulford D, Taggart HM, Nivens A, Payrie C. Arch support use for improving balance and reducing pain in older adults. Appl Nurs Res. 2008 Aug;21(3):153-8. doi: 10.1016/j.apnr.2006.08.006.
de Morais Barbosa C, Barros Bertolo M, Marques Neto JF, Bellini Coimbra I, Davitt M, de Paiva Magalhaes E. The effect of foot orthoses on balance, foot pain and disability in elderly women with osteoporosis: a randomized clinical trial. Rheumatology (Oxford). 2013 Mar;52(3):515-22. doi: 10.1093/rheumatology/kes300. Epub 2012 Nov 28.
Perry SD, Radtke A, McIlroy WE, Fernie GR, Maki BE. Efficacy and effectiveness of a balance-enhancing insole. J Gerontol A Biol Sci Med Sci. 2008 Jun;63(6):595-602. doi: 10.1093/gerona/63.6.595.
Riskowski JL, Hagedorn TJ, Hannan MT. Measures of foot function, foot health, and foot pain: American Academy of Orthopedic Surgeons Lower Limb Outcomes Assessment: Foot and Ankle Module (AAOS-FAM), Bristol Foot Score (BFS), Revised Foot Function Index (FFI-R), Foot Health Status Questionnaire (FHSQ), Manchester Foot Pain and Disability Index (MFPDI), Podiatric Health Questionnaire (PHQ), and Rowan Foot Pain Assessment (ROFPAQ). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S229-39. doi: 10.1002/acr.20554. No abstract available.
Delbaere K, Close JC, Mikolaizak AS, Sachdev PS, Brodaty H, Lord SR. The Falls Efficacy Scale International (FES-I). A comprehensive longitudinal validation study. Age Ageing. 2010 Mar;39(2):210-6. doi: 10.1093/ageing/afp225. Epub 2010 Jan 8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FFPETFETS003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.