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 |
| Protocol serial number | N0170141303 |
| Sponsor | Department of Health |
| Funder | Nottingham City Hospital NHS Trust (UK), NHS R&D Support Funding |
- 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 of protocol
Not provided at time of registration
Contact information
Dr G Chow
Scientific
Scientific
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised cross-over study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
The benefits of silicone over traditional AFOs |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion 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 sample size at registration | 6 |
| Key inclusion criteria | 1. Six children with Charcot-Marie Tooth disease 2. Children aged 4-16 with proven HMSN and therefore foot drop |
| Key exclusion criteria | Children with no foot drop. |
| Date of first enrolment | 15/05/2004 |
| Date of final enrolment | 15/11/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
