Recruiting

AFO vs. Surgical Correction

Sponsor:

Bopha Chrea

Code:

NCT07188415

Conditions

Charcot Marie Tooth Disease (CMT)

Eligibility Criteria

Sex: All

Age: 25 - 55

Healthy Volunteers: Not accepted

Interventions

Ankle-foot Orthoses

Study Details

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)

Study ID

NCT07188415

Start date

Aug 14, 2025

Status verified date

Sep, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria: 1) Clinical diagnosis and genetic confirmation of CMT, 2) Between the ages of 12 and 75, 3) Able to walk at a slow to moderate pace without an AFO, 3) Able to read and write in English and provide written informed consent. 4) Individuals in the NonOP group must have an AFO prescribed for daily activities. Individuals in the OP group will also have had 5) surgical correction of CMT cavovarus foot deformity focused on muscle balancing and hindfoot correction.

Exclusion Criteria: 1) Other causes or risk factors for peripheral neuropathy (for example diabetes, ETOH abuse), 2) Uncorrected visual impairment, 3) History of musculoskeletal injury requiring surgery 4) loss of plantar protective sensation 5) Pain >4/10 while walking (or an increase in pain during testing of >2/10), 6) Concern by the examiner that the individual will not complete the study. For the NonOP group 7) Previous surgical correction of CMT cavovarus foot deformity focused on muscle balancing and hindfoot correction

Study Design

Enrollment

66 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: OP

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

other: NonOP

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.

Interventions

Ankle-foot Orthoses

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).

Primary outcome measure

  • Four-Square Step Test [ Time Frame: Baseline ]
  • Self-selected Walking Velocity [ Time Frame: Baseline ]
  • Activity Specific Balance Confidence Scale [ Time Frame: Baseline ]
  • Falls Frequency Questionnaire [ Time Frame: Baseline ]
  • Lower Extremity Gait Biomechanics [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Bopha Chrea, MD

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

Lauren Crowe, BS

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

Locations

University of Iowa Medical Campus - North Liberty (MCNL)

Recruiting

North Liberty, Iowa, United States, 52713

Contacts

Bopha Chrea, MD

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

Jason Wilken, PT, PhD

jason-wilken@uiowa.edu

More Information

Sponsor

Bopha Chrea

Last update posted

Sep 23, 2025

Last verified

Sep, 2025

Keywords

  • Gait Biomechanics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bopha Chrea on 2025-09-23.