Condition category
Nervous System Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
11/04/2014
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 G Chow

ORCID ID

Contact details

Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0170141303

Study information

Scientific title

Acronym

Study hypothesis

Do silicone ankle foot orthosis (AFOs) offer similar benefits to children with Hereditary Motor Sensory Neuropathy (HMSN) in terms of walking and Quality of Life measures as do traditional AFOs?

Ethics approval

Not provided at time of registration

Study design

Randomised cross-over study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Nervous System Diseases: Charcot-Marie Tooth (CMT) Disease

Intervention

Randomised cross-over study. Gait analysis performed in Human Performance Laboratory

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The benefits of silicone over traditional AFOs

Secondary outcome measures

Not provided at time of registration

Overall trial start date

15/05/2004

Overall trial end date

15/11/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Six children with Charcot-Marie Tooth disease
2. Children aged 4-16 with proven HMSN and therefore foot drop

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

6

Participant exclusion criteria

Children with no foot drop.

Recruitment start date

15/05/2004

Recruitment end date

15/11/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

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

Nottingham City Hospital NHS 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

Publication citations

Additional files

Editorial Notes