The effect of two different ankle-foot-orthoses on walking and quality of life in children with Hereditary Motor and Sensory Neuropathy (HMSN) - also known as Charcot-Marie Tooth (CMT) Disease.
| ISRCTN | ISRCTN94187624 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94187624 |
| Secondary identifying numbers | N0170141303 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 11/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr G Chow
Scientific
Scientific
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
Study information
| Study design | Randomised cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| 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(s) | Not provided at time of registration |
| Condition | Nervous System Diseases: Charcot-Marie Tooth (CMT) Disease |
| Intervention | Randomised cross-over study. Gait analysis performed in Human Performance Laboratory |
| Intervention type | Other |
| Primary outcome measure | The benefits of silicone over traditional AFOs |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 15/05/2004 |
| Overall study end date | 15/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 16 Years |
| Sex | Not Specified |
| Target number of participants | 6 |
| Participant inclusion criteria | 1. Six children with Charcot-Marie Tooth disease 2. Children aged 4-16 with proven HMSN and therefore foot drop |
| Participant exclusion criteria | Children with no foot drop. |
| Recruitment start date | 15/05/2004 |
| Recruitment end date | 15/11/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Nottingham City Hospital NHS Trust (UK), NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
