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Orthotics, Pain & Fear of Falling

NCT04894396 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2023-05-06

No results posted yet for this study

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.

Conditions

  • Foot Pain
  • Foot Functionality
  • Fear of Falling

Interventions

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.

Sponsors & Collaborators

  • Aetrex Worldwide Inc

    collaborator INDUSTRY

  • Talita Cumi Ltd.

    lead INDUSTRY

Principal Investigators

  • George Ampat, MBBS, MS, FRCS · Talita Cumi Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-23
Primary Completion
2022-08-31
Completion
2023-01-15

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04894396 on ClinicalTrials.gov