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22 May 2012
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| [ Print-friendly version ] |
| 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 |
| ClinicalTrials.gov identifier | |
| Public title | A pilot study of a cross trial with randomised use of ankle foot orthoses and Ligaflex for People with Charcot Marie Tooth disease |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N0077170544 |
| 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. |
| Lay summary | Not provided at time of registration |
| Ethics approval | Not provided at time of registration |
| Study design | Pilot RCT |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Nervous System Diseases: Charcot-Marie Tooth (CMT) Disease |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/01/2006 |
| Anticipated end date | 01/07/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 15 |
| Interventions | 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). |
| 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 |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding |
| Trial website | |
| Publications | |
| Contact name | Dr Margaret Phillips |
| Address |
Derby Hospitals NHS Foundation Trust
Rehabilitation Research Unit Derby City General Hospital Uttoxeter Road |
| City/town | Derby |
| Zip/Postcode | DE22 3NE |
| Country | United Kingdom |
| Tel | +44 (0)1332 785681 |
| Fax | +44 (0)1332 625681 |
| margaret.phillips@nottingham.ac.uk | |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Address | The Department of Health, Richmond House, 79 Whitehall |
| City/town | London |
| Zip/Postcode | SW1A 2NL |
| Country | United Kingdom |
| Tel | +44 (0)20 7307 2622 |
| dhmail@doh.gsi.org.uk | |
| Sponsor website: | http://www.dh.gov.uk/Home/fs/en |
| Date applied | 29/09/2006 |
| Last edited | 14/11/2011 |
| Date ISRCTN assigned | 29/09/2006 |
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| © 2012 ISRCTN unless otherwise stated. | |
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