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

ISRCTN	ISRCTN61814249
DOI	https://doi.org/10.1186/ISRCTN61814249
Protocol serial number	N0077170544
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 29/04/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Margaret Phillips
Scientific

Derby Hospitals NHS Foundation Trust
Rehabilitation Research Unit
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Phone	+44 (0)1332 785681
Email	margaret.phillips@nottingham.ac.uk

Study information

Primary study design	Interventional
Study design	Pilot randomised controlled trial
Secondary study design	Randomised controlled trial
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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/07/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	15
Key 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
Key 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
Date of first enrolment	01/01/2006
Date of final enrolment	01/07/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Derby Hospitals NHS Foundation Trust

Derby
DE22 3NE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2012		Yes	No