Nervous System Diseases: Charcot-Marie Tooth (CMT) Disease Nervous System Diseases Charcot-Marie Tooth (CMT) Disease
Conditions
Interventions
Participants will be eight people with CMT with clinical need for an AFO or Ligaflex, using specified criteria. The study is limited to people with CMT, the commonest inherited neuromuscular condition
Sponsors
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Eligibility
Inclusion criteria
Inclusion criteria: Identified from those attending muscle or neurology clinics in Derby Hospitals. Random sample of 15 approached by letter with patient information sheet. A second letter will be sent if no reply after 2 weeks. If uptake inadequate further letters will be sent after random selection. If an interest is expressed they will be interviewed by the research assistant (RA), either in their own home or in hospital - whichever they prefer. The RA will explain the study in detail, answer queries and take informed consent. Inclusion Criteria: 1. Symptomatic CMT confirmed either on nerve conduction or genetic testing 2. Foot drop in at least one lower limb with grade 4 muscle weakness or lower
Exclusion criteria
Exclusion criteria: 1. Other disorder affecting ability to walk - as will confound results 2. Lower limb oedema - as will cause difficulties in orthotic fit and make skin breakdown more likely 3. Diabetes mellitus - as may further reduce sensation and also increase risk of skin infection or pressure sores. 4. Inability to walk 10 metres - as will not be able to participate in gait analysis or 10m walk 5. Age below 16 years old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Impairment caused by CMT (record of sensory loss, foot/ankle deformity and motor impairment) 2. Walking velocity over a specified route that involves flat ground and steps 3. Borg scale of perceived exertion of walking around a this route 4. Total heart beat index 5. Walking velocity over 10m 6. Change in joint kinetics/kinematics: ankle, knee, hip and trunk 7. Change in step length 8. Cost of AFO and Ligaflex (including components, orthotist time and patient time and travel) 9. Berg balance scale 10. Number of falls over assessment week 11. Goal Attainment Scale for participant chosen goals of wearing AFO (same for each AFO) 13. Impact on participation and autonomy scale (IPA) 14. Likert scales regarding comfort, function, cosmesis, ease of.donning and doffing, pain, overall satisfaction, change in abilities, whether the user would use the AFO or Ligaflex if it were prescribed,fulfilment of properties participant chooses for AFO, ranking of preference after final AFO or Ligaflex worn 15. Costs and times of orthoses, their manufacture, health professional contact time, patient time, travel | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed