Charcot-Marie-Tooth disease Nervous System Diseases Hereditary and idiopathic neuropathy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: People will be recruited provided all of the following criteria are satisfied: 1. Clinical diagnosis of Charcot-Marie-Tooth disease (CMT) 2. Aged 18 to 70 years, either sex 3. Able to walk for 50 m with or without a walking aid or orthotic devices 4. Signed informed participant consent
Exclusion criteria
Exclusion criteria: People will be excluded from the study if one or more of the following criteria apply: 1. Presence of other significant neurological disorders (such as multiple sclerosis, cerebrovascular diseases, movement disorders), or major comorbidities (e.g., definite cognitive impairment, psychiatric disease, heart or lung failure, orthopaedic or rheumatological disorders) 2. Limb surgery during the six months prior to screening (or planned before final assessment) 3. Severe congenital hip dysplasia associated with CMT 4. Aged over 70 or under 18 years 5. Women of child-bearing age only if they are pregnant at the inclusion into the study or plan to become pregnant during the study (people agreeing not to become pregnant during the study must take appropriate contraceptive methods - contraceptive pill, intrauterine device, barrier methods)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Isometric muscle strength of the hip flexors - measured using fixed myometry. Timepoints: Group A: Baseline (0 weeks), post-intervention (16 weeks), post-washout (24 weeks), final measurement (40 weeks) Group B: Baseline (0 weeks), post-control (16 weeks), post-intervention (32 weeks), post-washout (40 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Six Minute Timed Walk Test: change in maximal walking distance in 6 minutes and peak heart rate 2. Walking speed: using a Timed 10 Metre Walk Test 3. Perceived exertion during the Six Minute Timed Walk Test: using the Borg 15-point scale 4. Heart rate and Physiological Cost Index (PCI) during the Six Minute Timed Walk Test: using a heart rate monitor 5. Fatigue: assessed using the Fatigue Severity Scale (FSS) 6. Perception of walking ability: Walk-12 scale 7. Disease severity: Charcot-Marie-Tooth Symptom/Sign Score (CMTSS) 8. Physical limitations: Overall Neuropathy Limitations Scale (ONLS) 9. Pain: assessed using the Visual Analogue Scale (VAS) Timepoints: Group A: Baseline (0 weeks), post-intervention (16 weeks), post-washout (24 weeks), final measurement (40 weeks) Group B: Baseline (0 weeks), post-control (16 weeks), post-intervention (32 weeks), post- washout (40 weeks) | — |
Countries
United Kingdom