About this trial
The goal of this study is to compare changes in walking ability in people with Charcot-Marie-Tooth disease (CMT) who receive two different treatment approaches for foot deformities that affect walking.
CMT is an inherited nerve condition that can cause muscle weakness, loss of sensation, and foot deformities. These changes often make walking difficult and can reduce independence and quality of life. Treatment options commonly include physical therapy alone or surgery to correct foot alignment followed by rehabilitation. However, it is not clear whether one approach leads to better long-term walking outcomes.
The main question this study aims to answer is whether individuals who undergo functional foot surgery followed by rehabilitation experience different changes in walking ability over time compared with those who receive structured physical therapy alone.
Researchers will compare walking performance between these two treatment groups over a period of up to two years. Walking ability will be evaluated using standardized walking tests and patient questionnaires.
Participants included in this study are individuals with CMT-related foot deformities that affect walking and who received either surgery followed by rehabilitation or physical therapy alone. Researchers will analyze changes in walking ability over time and determine how many participants achieve meaningful improvement.
The findings from this study may help clinicians and individuals with CMT better understand how different treatment strategies influence walking function over time.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants aged 12 years or older at the time of enrollment
Genetically or clinically confirmed CMT, based on established diagnostic criteria
Presence of foot deformity and/or gait impairment attributable to CMT, as determined by a treating clinician
Ability to ambulate at least 10 meters, with or without assistive devices
Disqualifiers
Previous major foot or ankle surgery that substantially altered lower-limb biomechanics
Presence of non-CMT-related neurological disorders affecting gait (eg, stroke, Parkinson disease, multiple sclerosis)
Severe musculoskeletal conditions unrelated to CMT that limit walking ability (eg, advanced hip or knee osteoarthritis)
Active lower-limb infection, ulceration, or acute injury at the time of enrollment
Trial population
The study population comprises adults with Charcot-Marie-Tooth disease (CMT) evaluated and treated at a tertiary referral center specializing in neuromuscular and foot and ankle disorders. Participants were identified from consecutive clinical encounters beginning in February 2017, incorporating both retrospectively and prospectively collected data. Eligible individuals had a genetically or clinically confirmed diagnosis of CMT and presented with foot deformity and gait impairment attributable to peripheral neuropathy. All participants were ambulatory, with or without assistive devices, at the time of enrollment. Management strategies included functional surgical intervention followed by rehabilitation or structured physical therapy alone, reflecting routine clinical practice. Longitudinal outcome data were obtained through standardized assessments conducted at baseline and predefined follow-up time points throughout the study period.
Trial design
Cohort
Prospective
Treatments tested in this trial
Functional Surgery plus Rehabilitation
Procedure/SurgeryFS group underwent individualized surgical correction aimed at improving foot alignment, restoring muscle-tendon balance, and optimizing walking mechanics. Surgical procedures included soft tissue release, tendon transfers to augment weakened muscles, and calcaneal osteotomy for hindfoot malalignment. Arthrodesis was reserved for rigid deformities or painful osteoarthritis not amenable to realignment. All surgically treated participants followed a standardized postoperative rehabilitation program, consisting of an initial 2-week period of immobilization with non-weight-bearing, followed by partial weight-bearing with a removable orthosis from weeks 2 to 6, progression to full weight-bearing between weeks 6 and 12, and a structured rehabilitation phase from weeks 12 to 24 emphasizing strengthening, balance training, and task-specific gait retraining. Afterward, participants continued rehabilitation using the same protocol applied to the physical therapy group.
Physical Exercise
BehavioralParticipants in the PE group received structured physical therapy without surgical intervention. Programs were individualized based on disease severity and functional capacity to improve walking ability, balance, and lower-limb coordination. Therapy included aerobic exercise, ankle mobility exercises, lower-limb stretching, and balance training, all performed within the available range of motion. After an initial supervised phase, participants transitioned to a home-based, self-supervised program performed approximately twice weekly for up to 12 months. Aerobic training was conducted at moderate intensity using a stationary bicycle or seated alternatives when needed. Exercises were modified as necessary to avoid pain or excessive fatigue.
Treatment groups
Trial outcomes
Primary outcomes
the 10-Meter Walk Test (10MWT)
Habitual walking speed was determined using the 10-Meter Walk Test (10MWT) and expressed in meters per second (m/s), with higher values reflecting faster walking speed.
the 6-Minute Walk Test (6MWT)
Functional walking capacity was assessed using the 6-Minute Walk Test (6MWT) and expressed in meters walked during 6 minutes, with higher values reflecting greater walking endurance.
Secondary outcomes
the Walk-12 Questionnaire
Walking-related disability was assessed using the 12-item Walk-12 questionnaire and expressed as total score according to standardized scoring procedures, with higher scores reflecting greater perceived walking limitation.
the Foot and Ankle Disability Index (FADI)
Foot and ankle-specific functional status was assessed using the Foot and Ankle Disability Index (FADI) and expressed as total score according to standardized scoring procedures, with higher scores reflecting better function.
the American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score
Hindfoot function was assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score and expressed in points on a 0-100 scale, with higher scores reflecting better clinical function.
the 12-Item Short Form Health Survey (SF-12)
Health-related quality of life was assessed using the 12-Item Short Form Health Survey (SF-12), including Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, expressed in standardized score units, with higher scores reflecting better health status.
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