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Orthofeet: A Prospective Proof of Concept Trial to Evaluate an Innovative Pain Relief Footwear

NCT ID: NCT05434078

Last Updated: 2024-12-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-18

Study Completion Date

2024-08-30

Brief Summary

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The purpose of this prospective randomized crossover study is to evaluate the effectiveness of a new pain relief footwear, Orthofeet, in reducing foot pain and improving daily physical activity. The investigators hypothesize that wearing Orthofeet shoes will lead to a reduction in foot pain, resulting in increased daily physical activity, objectively measured using validated wearable devices.

Detailed Description

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A clinical study at Baylor College of Medicine is being conducted to evaluate the short- and intermediate-term benefits and effectiveness of a novel pain relief footwear, Orthofeet. This 12-week randomized crossover trial aims to recruit 50 eligible ambulatory adults (aged 50 years or older) with moderate self-reported foot pain. Participants will be randomly assigned to Group AB (25 subjects) or Group BA (25 subjects), with no differences in assessments or eligibility criteria between the groups. In Group AB, participants will wear Orthofeet shoes for 6 weeks, followed by their own shoes for another 6 weeks, while Group BA will follow the reverse order. Pain and function, the primary outcomes, will be measured using the Foot Function Index (FFI), and acceptability will be assessed using a Technology Acceptance Model (TAM) questionnaire. Data will be collected at baseline, 6 weeks, and 12 weeks.

Conditions

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Foot Pain

Keywords

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foot pain falls frailty footwear mobility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group AB

Group AB will be started with 6-week Intervention A (OrthoFeet) and then switched to 6-week intervention B (own shoes)

Group Type ACTIVE_COMPARATOR

Orthofeet Shoes

Intervention Type DEVICE

Participants will wear a pair of Orthofeet shoes to wear for 6 weeks

Group BA

Group BA will be started with B (own shoes) for 6 weeks and then switched to Intervention A (OrthoFeet) for the same duration

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Orthofeet Shoes

Participants will wear a pair of Orthofeet shoes to wear for 6 weeks

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 50 years or older
* self reported foot pain including heel, arch, or ball of foot

Exclusion Criteria

* Plantar ulcer Patients with major foot deformity (e.g., Charcot foot, Pes Cavus)
* Lower extremity amputation including minor amputation. Foot pain because of nail disorder or keratotic lesions (e.g. corns, calluses)
* unstable conditions such as recent stroke, anticipated changes in medication regime
* Acute fractures of the foot
* Non-ambulatory or unable to stand without help or walk a distance of at least 6 feet without assistance.
* major cognitive impairment or major depression
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Orthofeet, Inc.

UNKNOWN

Sponsor Role collaborator

Bijan Najafi, PhD

OTHER

Sponsor Role lead

Responsible Party

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Bijan Najafi, PhD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

References

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Finco MG, Ouattas A, El-Refaei N, Momin AS, Azarian M, Najafi B. Assessing the Acceptability and Effectiveness of a Novel Therapeutic Footwear in Reducing Foot Pain and Improving Function among Older Adults: A Crossover Randomized Controlled Trial. Gerontology. 2024;70(8):842-854. doi: 10.1159/000539307. Epub 2024 May 22.

Reference Type BACKGROUND
PMID: 38776890 (View on PubMed)

Ouattas A, Finco MG, Dehghan Rouzi M, Azarian M, Rojas AZ, Bargas Ochoa M, El-Refaei N, Momin A, Najafi B. The role of therapeutic footwear to increase daily physical activity in older adults with chronic foot pain. Clin Biomech (Bristol). 2025 Mar;123:106373. doi: 10.1016/j.clinbiomech.2024.106373. Epub 2024 Oct 29.

Reference Type BACKGROUND
PMID: 39954566 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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51229

Identifier Type: -

Identifier Source: org_study_id