Condition category
Nervous System Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
29/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22089961

Publication citations

Additional files

Editorial Notes