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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.

Tracking Information
First Submitted Date  ICMJE May 14, 2021
First Posted Date  ICMJE May 20, 2021
Last Update Posted Date July 26, 2021
Actual Study Start Date  ICMJE July 23, 2021
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2021)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 19, 2021)
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Orthotics, Pain & Fear of Falling
Official Title  ICMJE A Randomised Control Trial Comparing Prefabricated Orthotics With and Without Metatarsal Pad in Decreasing Pain and Fear of Falling in Older Adults
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Foot Pain
  • Foot Functionality
  • Fear of Falling
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Aetrex L2305 Premium Memory Foam Orthotics W/ Metatarsal Support
  • 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
    Intervention: Device: Aetrex L2300 Premium Memory Foam Orthotics
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 19, 2021)
206
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: George Ampat, MBBS, MS, FRCS 07871590593 geampat@gmail.com
Contact: Jonathan Sims, BSc 01704808703 research@ampat.co.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04894396
Other Study ID Numbers  ICMJE FFPETFETS003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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.
Responsible Party Talita Cumi Ltd.
Study Sponsor  ICMJE Talita Cumi Ltd.
Collaborators  ICMJE Aetrex Worldwide Inc
Investigators  ICMJE
Principal Investigator: George Ampat, MBBS, MS, FRCS Talita Cumi Ltd.
PRS Account Talita Cumi Ltd.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP