Ankle-foot braces versus surgery to improve walking and balance in CMT
Lower Extremity Gait, Mobility and Balance Confidence in Charcot-Marie-Tooth Patients With Cavovarus Foot Deformity
This will test whether ankle-foot braces or surgical correction better improve walking, balance, and mobility for people aged 12 to 75 with genetically confirmed Charcot–Marie–Tooth disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 25 Years to 55 Years |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (North Liberty, Iowa) |
| Trial ID | NCT07188415 on ClinicalTrials.gov |
What this trial studies
This study compares the effects of ankle-foot orthoses (AFOs) and surgical correction on gait, mobility, and balance in people with Charcot–Marie–Tooth disease. Participants who either use an AFO daily or have had corrective surgery will complete standardized mobility and balance tests in a gait analysis laboratory while walking with and without their AFO. Researchers will record gait biomechanics, balance performance, and fall-risk indicators to compare how each approach affects walking safety and efficiency. The trial enrolls ages 12–75 with genetic confirmation of CMT and excludes those with other neuropathy causes, significant pain, or loss of protective foot sensation.
Who should consider this trial
Good fit: Ideal candidates are people aged 12–75 with genetically confirmed CMT who can walk at a slow to moderate pace without an AFO and either use an AFO daily or have undergone corrective foot surgery.
Not a fit: People with other causes of neuropathy (such as diabetes), uncorrected visual impairment, loss of plantar protective sensation, significant walking pain, or those who cannot travel to the lab are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the results could help patients and clinicians choose AFOs or surgery that better reduce falls and improve everyday walking.
How similar studies have performed: Rigorous comparative evidence is limited and prior work has been largely observational, so direct comparisons between AFOs and surgery remain relatively untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
North Liberty, Iowa
- University of Iowa Medical Campus - North Liberty (MCNL) — North Liberty, Iowa, United States (Recruiting)
Study contacts
- Study coordinator: Bopha Chrea, MD
- Email: bopha-chrea@uiowa.edu
- Phone: 319-356-3943
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.