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
Secondary identifying numbers N0077170544
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

Study designPilot randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleA pilot study of a cross trial with randomised use of ankle foot orthoses and Ligaflex for People with Charcot Marie Tooth disease
Study objectivesThe 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) studiedNervous System Diseases: Charcot-Marie Tooth (CMT) Disease
InterventionParticipants 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 typeOther
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/01/2006
Completion date01/07/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants15
Key inclusion criteriaIdentified 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 criteria1. 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 enrolment01/01/2006
Date of final enrolment01/07/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Derby Hospitals NHS Foundation Trust
Derby
DE22 3NE
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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