CMT Gait, Mobility, Balance - AOFAS Grant

NCT ID: NCT07188415

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-14
• Study Completion Date: 2027-01-31

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.

Detailed Description

Walking is an important daily activity that is compromised in individuals with neuromuscular conditions. Charcot-Marie-Tooth (CMT) disease is the most common form of inherited peripheral neuropathy, affecting 2.8 million people worldwide and 1 in 2500 in the United States. Amongst patients with CMT, impaired walking is the most significant contributor to reduced quality of life in patients with CMT. Furthermore, these gait deficits result in over 80% of individuals with CMT experiencing a fall or near fall event annually, primarily due to tripping and balance related issues. Ankle foot orthoses (AFOs) are commonly used by individuals with CMT, often with the intent of reducing the risk of falls and restoring a more normal gait pattern. However, AFOs are often bulky, uncomfortable, and can be destabilizing for already weak individuals. Surgical correction offers the advantage of improving limb alignment, reduces bulk, and the arduous nature of donning/doffing a brace. However, surgery is not without risk, potential complications, and post-operative recovery. Scientific evidence to help surgeons determine if an AFO or surgery are optimal for a given patient, especially in the setting of a brace-able foot, remains limited. Recent consensus among expert orthopaedic foot and ankle surgeons agrees that 'There is no evidence-based orthopedic studies to help determine optimal timing for surgery, and there is often contradictory advice from the patient's neurologist, physical therapist, and orthotist regarding the role of an operation. There is a critical need to understand how surgical correction affects mobility, balance confidence, and gait compared to AFO bracing in the native cavovarus foot (non-operatively treated). Without such information, the evidence-based approach to answering this critical question will likely remain unrealized.

Conditions

Charcot Marie Tooth Disease (CMT)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

OP

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: OTHER

Ankle-foot Orthoses

Intervention Type: 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).

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bopha Chrea

OTHER

Sponsor Role: lead

Responsible Party

Bopha Chrea

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Iowa Medical Campus - North Liberty (MCNL)

North Liberty, Iowa, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Bopha Chrea, MD

Role: CONTACT

bopha-chrea@uiowa.edu

319-356-3943

Lauren Crowe, BS

Role: CONTACT

lauren-n-crowe@uiowa.edu

319-467-7128

Facility Contacts

Bopha Chrea, MD

Role: primary

bopha-chrea@uiowa.edu

319-356-3943

Jason Wilken, PT, PhD

Role: backup

jason-wilken@uiowa.edu

Other Identifiers

202503402

Identifier Type: -

Identifier Source: org_study_id