Contact information
Type
Scientific
Primary contact
Dr Margaret Phillips
ORCID ID
Contact details
Derby Hospitals NHS Foundation Trust
Rehabilitation Research Unit
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
+44 (0)1332 785681
margaret.phillips@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0077170544
Study information
Scientific title
A pilot study of a cross trial with randomised use of ankle foot orthoses and Ligaflex for People with Charcot Marie Tooth disease
Acronym
Study hypothesis
The objective is to pilot a study that compares 3 different types of ankle foot orthosis (AFO) in people with Charcot Marie Tooth disease.
This is a pilot study, so the general aim is test how practical the protocol is and how we might put it into practice in a larger study. As regards consultation this pilot itself will allow consultation for the larger study. The sponsor for the study is the Muscular Dystrophy Campaign, who are one of the main patient bodies concerned in the UK.
Ethics approval
Not provided at time of registration
Study design
Pilot randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Nervous System Diseases: Charcot-Marie Tooth (CMT) Disease
Intervention
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, to reduce variability. Participants may be present or previous users of AFOs, or may never have used them. They will wear three different AFO's during the course of the study: custom made polypropylene, Lygaflex and silicone (Dorset orthopaedic).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 outcome measures
Not provided at time of registration
Overall trial start date
01/01/2006
Overall trial end date
01/07/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
15
Participant 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
Recruitment start date
01/01/2006
Recruitment end date
01/07/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Derby Hospitals NHS Foundation Trust
Derby
DE22 3NE
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22089961