|
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:
|
21 June 2021 |
|
Main ID: |
NCT03860662 |
|
Date of registration:
|
08/02/2019 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The Effect of Oral Baclofen and Botulinum Toxin Treatments in Hemiplegic Spasticity on the Nociceptive Flexor Reflex
|
|
Scientific title:
|
Doctor, Physical Medicine and Rehabilitation |
|
Date of first enrolment:
|
May 26, 2018 |
|
Target sample size:
|
29 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03860662 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Turkey
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Being between the ages of 18-60
- To accept voluntary participation in the study
- Spastic Hemiplegia (Modified Ashworth Scale 2 and above)
Exclusion Criteria:
- Pregnant women, breastfeeding and younger than 18 years
- To have medication and substance use causing neuropathy in the history of the disease
and / or neuropathy
- Companies that have received botulinum toxin injection therapy and / or oral
antispastic therapy within the last 6 months
- Have a history of allergies and hypersensitivity to usability drug
- Injection treatment planned purification hematoma, cleaning or skin lesion to be
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Spastic Hemiplegia
|
|
Stroke Sequelae
|
|
Intervention(s)
|
|
Drug: Botox
|
|
Drug: Baclofen
|
|
Diagnostic Test: Nociceptor flexor reflex
|
|
Primary Outcome(s)
|
|
Visual analog scale
[Time Frame: 6 weeks]
|
|
Barthel index
[Time Frame: 6 weeks]
|
|
Modified Ashworth scale
[Time Frame: 6 weeks]
|
|
Range of motion
[Time Frame: 6 weeks]
|
|
thershold of nociceptive flexor reflex
[Time Frame: 6 weeks]
|
|
Secondary ID(s)
|
|
MustafaKUPMR
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|