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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03186664 |
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Date of registration:
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07/06/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Role of SAtivex® in Robotic-Rehabilitation
SARR |
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Scientific title:
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The Role of SAtivex® Associated With Robotic-Rehabilitation in Improving the Motor Performances of Multiple Sclerosis Patients (SARR) |
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Date of first enrolment:
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December 28, 2016 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03186664 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Italy
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Inclusion criteria were:
- age of 18-65 years,
- diagnosis of definite relapsing-remitting or primary-progressive Multiple Sclerosis,
-absence of clinical relapses from no gadolinium enhanced lesions on brain and spinal
cord MRI performed at least six months prior to study entry,
- no mood or sleep disorders (Hamilton score of <17),
- a moderate to severe spasticity in at least two districts of upper and/or lower limbs;
-absence of clinical or neuroradiological relapses from at least six months prior to
study entry,
- Expanded Disability Status Scale (EDSS) total score between 3.5 and 7.0,
- no history of psychosis,
- no presence of pace-maker, aneurysms clips, neurostimulator or brain/subdural
electrodes (safety TMS procedure),
- right handedness,
- central conduction time in upper limbs of <8 ms;
- no robotic gait traing contraindications.
Exclusion Criteria:
- History of psychosis,
- presence of pace-maker, aneurysms clips, neurostimulator or brain/subdural electrodes
(safety TMS procedure),
- central conduction time in upper limbs of <8 ms;
- robotic gait traing contraindications.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rehabilitation
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Intervention(s)
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Drug: Sativex
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Device: Lokomat training
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Primary Outcome(s)
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Functional Independence Measure
[Time Frame: eight months]
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10m walking test
[Time Frame: eight months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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