|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT03044080 |
|
Date of registration:
|
01/02/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effects of Botulinum Neurotoxin Type A (BoNT/A) Free of Complexing Proteins in the Spastic Equinovarus Foot
|
|
Scientific title:
|
Effects of Repeated Use of Botulinum Neurotoxin Type A (BoNT/A) Free of Complexing Proteins in the Spastic Equinovarus Foot in Stroke Patients: A Randomized Clinical Trial |
|
Date of first enrolment:
|
January 1, 2015 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03044080 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Spain
| | | | | | | |
|
Contacts
|
|
Name:
|
Esther Duarte, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Fundació IMIM - Parc de Salut Mar |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- First-ever Ischemic or haemorrhagic stroke
- Time since stroke onset: >6months
- Hemiparesis with equinovarus foot
- No previous BoNT/A
Exclusion Criteria:
- Non-ambulant patients
- Medical contraindications for BoNT/A use that appear in the product information sheet
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Stroke Rehabilitation Spasticity Management
|
|
Stroke Rehabilitation
|
|
Intervention(s)
|
|
Drug: IncobotulinumtoxinA
|
|
Drug: OnabotulinumtoxinA
|
|
Primary Outcome(s)
|
|
Change in walking speed
[Time Frame: Baseline and monthly during 18 months]
|
|
Secondary Outcome(s)
|
|
Change in functional ambulation ability assessed with the Modified Walking Categories
[Time Frame: Baseline and monthly during 18 months]
|
|
Change in spasticity assessed with the Modified Ashworth Scale
[Time Frame: Baseline and monthly during 18 months]
|
|
Change in walking disability assessed with the Scandinavian Stroke Scale
[Time Frame: Baseline and monthly during 18 months]
|
|
Change in step length
[Time Frame: Baseline and monthly during 18 months]
|
|
Change in step time
[Time Frame: Baseline and monthly during 18 months]
|
|
Secondary ID(s)
|
|
PSM/RHB/NR22
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|