CMT Gait, Mobility, Balance - AOFAS Grant

NCT07188415 | Recruiting FDA Device

• 1 other identifier: 202503402
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of the proposed research is to begin to better understand the potential benefits and limitations of ankle -foot orthosis (AFO) use in the context of mobility and balance during gait for individuals with Charcot-Marie-Tooth disease (CMT). These benefits will be studied in comparison to those offered by surgical correction. We will accomplish by having subjects undergo mobility and balance tests in our gait analysis lab.

Conditions

Charcot Marie Tooth Disease (CMT)

Keywords

Gait Biomechanics

Outcome Measures

Primary Outcomes (5)

• Four-Square Step Test

  This test of functional mobility requires rapid stepping and changes in direction, that are often limited by lower limb pathology.

  Baseline

• Self-selected Walking Velocity

  Participants will be instructed to walk at their "normal comfortable" pace for a 10 m distance. The time traveled between the 2 m mark and 8 m mark is recorded in seconds. Two trials will be completed with 15 seconds rest between trials.

  Baseline

• Activity Specific Balance Confidence Scale

  The ABC is a well-established survey instrument to assess an individual participant's level of balance confidence during functional activities and takes approximately 3 minutes to complete.

  Baseline

• Falls Frequency Questionnaire

  Survey asking participants the number of times they fell in the previous 24 hours and the previous week. Participants will also be asked to report the most circumstances most commonly associated with fall events.

  Baseline

• Lower Extremity Gait Biomechanics

  Measurements include: toe clearance height and ankle dorsiflexion angle during swing, peak ankle plantar flexor moment, and peak ankle push off power.

  Baseline

Study Arms (2)

OP

NO INTERVENTION

Charcot-Marie-Tooth patients who have undergone surgical correction but do not wear ankle-foot orthoses.

NonOP

OTHER

Charcot-Marie-Tooth patients who have not undergone surgical correction, but do wear clinically prescribed ankle-foot orthoses. NonOP subjects will complete study procedures both with and without their AFOs.

Device: Ankle-foot Orthoses

Interventions

Ankle-foot Orthoses DEVICE

Group 1 will consist of individuals who have CMT and have undergone surgical correction (OP) and Group 2 will be AFO users who have CMT but have not undergone major surgical correction (NonOP).

NonOP

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Bopha Chrea: lead

Study Sites (1)

University of Iowa Medical Campus - North Liberty (MCNL)

North Liberty, Iowa, 52713, United States

RECRUITING

MeSH Terms

Conditions

Charcot-Marie-Tooth Disease

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Central Study Contacts

Bopha Chrea, MD

CONTACT

319-356-3943; bopha-chrea@uiowa.edu

Lauren Crowe, BS

CONTACT

319-467-7128; lauren-n-crowe@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two groups will be recruited in this study, participants who have a history of surgical correction (OP) and participants who have no history of surgical correction for cavovarus foot deformity but do wear clinically prescribed ankle-foot orthotics (NonOP). Participants will complete valid and reliable tests of physical mobility and balance confidence under the direction and supervision of trained study staff. Individuals in the OP group will complete all activities without an AFO and individuals in the NonOP group will complete activities with and without their clinically prescribed ankle foot orthosis, to determine the effect of AFOs on mobility and balance confidence. NonOP participants will complete all procedures in a randomized order to prevent influence of testing order. Gait kinematics and kinetics will be measured using infra-red motion capture cameras (Vicon Motion Systems Ltd., Denver, CO) and force plates (AMTI, Watertown, MA).

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 23, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)