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Completed

NCT Number: NCT04894396

Orthotics, Pain & Fear of Falling

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.

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Key information

Conditions

Foot Pain Fear of Falling Foot Functionality

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Talita Cumi LTD.

Southport, Merseyside, PR8 3NS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aetrex L2305 Premium Memory Foam Orthotics W/ Metatarsal Support

Device

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

Device

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 outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Talita Cumi Ltd.

Industry

Collaborators

  • Aetrex Worldwide Inc

Registry information

Official study title

A Randomised Control Trial Comparing Prefabricated Orthotics With and Without Metatarsal Pad in Decreasing Pain and Fear of Falling in Older Adults

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 20, 2021
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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