NCT04894396

Brief Summary

To 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 23, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

May 14, 2021

Last Update Submit

May 4, 2023

Conditions

Foot PainFoot FunctionalityFear of Falling

Outcome Measures

Primary Outcomes (1)

  • Changes in pain as assessed by a Visual Analogue Scale (VAS)

    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.

    Baseline and 6 weeks

Secondary Outcomes (2)

  • Changes in foot pain & functionality as assessed by the Foot Health Status Questionnaire (FHSQ)

    Baseline and 6 weeks

  • Fear of falling as assessed by the Falls Efficacy Scale International (FES-I) short.

    Baseline and 6 weeks

Other Outcomes (2)

  • Analysis of foot structure using the Gaitway scanner.

    Baseline

  • Report how many hours, on average, the orthotics are worn each day.

    6 weeks

Study Arms (2)

Prefabricated Orthotics with metatarsal pad

EXPERIMENTAL

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

Prefabricated Orthotics without metatarsal pad.

ACTIVE COMPARATOR

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

Interventions

Aetrex L2305 Premium Memory Foam Orthotics W/ Metatarsal SupportDEVICE

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 with metatarsal pad
Aetrex L2300 Premium Memory Foam OrthoticsDEVICE

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.

Prefabricated Orthotics without metatarsal pad.

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A least 60 years of age
  • Live in a community-based setting
  • Are capable of ambulation
  • Have some form of self-identified foot pain

You may not qualify if:

  • Compromised skin integrity of the lower limbs
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Talita Cumi LTD.

Southport, Merseyside, PR8 3NS, United Kingdom

Location

Related Publications (14)

  • 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.

    PMID: 27451329BACKGROUND

  • 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.

    PMID: 26977599BACKGROUND

  • 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.

    PMID: 31190764BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 18032400BACKGROUND

  • 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.

    PMID: 22019150RESULT

  • 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.

    PMID: 21106703RESULT

  • 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.

    PMID: 2816562RESULT

  • 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.

    PMID: 12164987RESULT

  • 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.

    PMID: 18684409RESULT

  • 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.

    PMID: 23192905RESULT

  • 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.

    PMID: 18559634RESULT

  • 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.

    PMID: 22588747RESULT

  • 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.

    PMID: 20061508RESULT

Study Officials

  • George Ampat, MBBS, MS, FRCS

    Talita Cumi Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2021

First Posted

May 20, 2021

Study Start

July 23, 2021

Primary Completion

August 31, 2022

Study Completion

January 15, 2023

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

At the end of the study, data will be fully anonymised. Only non-identifiable, anonymised data will be archived along with the publication for use of other researchers. For instance, the age, sex, and study results of participants will be archived indefinitely as a supplementary document to the publication.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The data will become available at the completion of the study on 31/12/2022. It will be available for other researchers indefinitely.
Access Criteria
The non-identifiable data will be openly available as a supplementary document to the publication.

Locations

GB(1)