Charcot Marie Tooth Disease (CMT)NCT07188415
CMT Gait, Mobility, Balance - AOFAS Grant
A study testing Ankle-foot Orthoses in people with Charcot Marie Tooth Disease (CMT), run by Bopha Chrea at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Charcot Marie Tooth Disease (CMT)
- What is being tested?
- Ankle-foot Orthoses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa Medical Campus - North Liberty (MCNL)
North Liberty, Iowa, 52713
Bopha Chrea, MD, 319-356-3943, bopha-chrea@uiowa.edu
Jason Wilken, PT, PhD, jason-wilken@uiowa.edu
About this study
Official title: Lower Extremity Gait, Mobility and Balance Confidence in Charcot-Marie-Tooth Patients With Cavovarus Foot Deformity
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.
Read the 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)
- Being tested
- Ankle-foot Orthoses
- Keywords
- Gait Biomechanics
- Medical subject headings
- Charcot-Marie-Tooth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle-foot OrthosesDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ankle-foot Orthoses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Four-Square Step Test
This test of functional mobility requires rapid stepping and changes in direction, that are often limited by lower limb pathology.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start14 Aug 2025
- Primary completionAug 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Charcot Marie Tooth Disease (CMT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bopha Chrea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bopha Chrea, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188415
- Sponsor's protocol ID
- 202503402
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Extremity Gait, Mobility and Balance Confidence in Charcot-Marie-Tooth Patients With Cavovarus Foot Deformity
- ClinicalTrials.gov ID
- NCT07188415
- Acronym / sponsor ID
- 202503402
- Conditions
- Charcot Marie Tooth Disease (CMT)
- Keywords
- Gait Biomechanics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Bopha ChreaUniversity, hospital or other
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| OP | No intervention | –Charcot-Marie-Tooth patients who have undergone surgical correction but do not wear ankle-foot orthoses. |
| NonOP | Other | Device: Ankle-foot OrthosesCharcot-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. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ankle-foot OrthosesGroup 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). | Device | NonOP |
Primary outcome
Four-Square Step Test
Time frame: Baseline
This test of functional mobility requires rapid stepping and changes in direction, that are often limited by lower limb pathology.
Self-selected Walking Velocity
Time frame: Baseline
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.
Activity Specific Balance Confidence Scale
Time frame: Baseline
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.
Falls Frequency Questionnaire
Time frame: Baseline
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.
Lower Extremity Gait Biomechanics
Time frame: Baseline
Measurements include: toe clearance height and ankle dorsiflexion angle during swing, peak ankle plantar flexor moment, and peak ankle push off power.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle-foot Orthoses in people with Charcot Marie Tooth Disease (CMT), run by Bopha Chrea at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bopha Chrea, MD (319-356-3943, bopha-chrea@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Four-Square Step Test (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.