A pilot study of a cross trial with randomised use of ankle foot orthoses and Ligaflex for People with Charcot Marie Tooth disease

Not Applicable

Completed

• Conditions: ervous System Diseases: Charcot-Marie Tooth (CMT) Disease; Nervous System Diseases; Charcot-Marie Tooth (CMT) Disease

• Registration Number: ISRCTN61814249
• Lead Sponsor: Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-29
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified