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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
Sponsor:
Collaborator:
Aetrex Worldwide Inc
Information provided by (Responsible Party):
Talita Cumi Ltd.

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.

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls Foot Health

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: George Ampat, MBBS, MS, FRCS 07871590593 geampat@gmail.com
Contact: Jonathan Sims, BSc 01704808703 research@ampat.co.uk

Locations
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United Kingdom
Talita Cumi LTD. Recruiting
Southport, Merseyside, United Kingdom, PR8 3NS
Contact: George Ampat, MBBS, MS, FRCS    07871 590593    geampat@gmail.com   
Contact: Jonathan M Sims, BSc    01704808703    research@ampat.co.uk   
Principal Investigator: George Ampat, MBBS, MS, FRCS         
Sub-Investigator: Jonathan Sims, BSc         
Sub-Investigator: Benjamin Bradley         
Sub-Investigator: Bertie Parkinson         
Sponsors and Collaborators
Talita Cumi Ltd.
Aetrex Worldwide Inc
Investigators
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Principal Investigator: George Ampat, MBBS, MS, FRCS Talita Cumi Ltd.
Publications of Results:

Other Publications:
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Responsible Party: Talita Cumi Ltd.
ClinicalTrials.gov Identifier: NCT04894396    
Other Study ID Numbers: FFPETFETS003
First Posted: May 20, 2021    Key Record Dates
Last Update Posted: July 26, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No