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 |
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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
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 |
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margaret.phillips@nottingham.ac.uk |
Study information
Study design | Pilot randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 | 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 study start date | 01/01/2006 |
Completion date | 01/07/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 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
- England
- United Kingdom
Study participating centre
Derby Hospitals NHS Foundation Trust
Derby
DE22 3NE
United Kingdom
DE22 3NE
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/06/2012 | Yes | No |