To Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Multiple Sclerosis Patients
|ClinicalTrials.gov Identifier: NCT01080040|
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : October 16, 2013
This study is observational, non-controlled, multicentric and prospective, without experimental intervention or control. As part of the usual management of the subjects, scales will be used for the assessment of the spasticity and the quality of life (QoL).
The purpose of this observational study is to assess the incidence of spasticity in a group of subjects with Relapsing Remitting Multiple Sclerosis (RRMS) in Argentina and the way it affects the QoL of these subjects.
|Condition or disease|
|Multiple Sclerosis, Relapsing Remitting|
One of most frequently observed symptoms in subjects with MS is spasticity. Spasticity is defined as an abnormal velocity-dependent increase in muscle tonic stretch reflexes due to an amplified reactivity of motor segments to sensory input. It is part of one of the components of the superior motoneurone syndrome and it may cause muscle rigidity and disability.
The spasticity, which could be measured in electrophysiological, biomechanical and clinical terms, has a significant prevalence. It is a frequent cause for consultation among subjects with MS and, consequently, has a significant impact on the QoL. Men and those subjects with MS of longer duration are the most affected by spasticity.
The aim of this study is to assess the impact that spasticity has on the QoL of subjects with MS.
The total duration of the study is 24 months. The recruiting period will be 12 months. Once the recruiting time is over, the collection of data will continue during the full 24 months period that was planned.
|Study Type :||Observational|
|Actual Enrollment :||150 participants|
|Official Title:||Observational Study to Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Patients With Multiple Sclerosis in Argentina|
|Study Start Date :||August 2008|
|Primary Completion Date :||March 2013|
|Study Completion Date :||March 2013|
- Assess the prevalence of spasticity in subjects with RRMS [ Time Frame: Initial visit (Day 0) to 24 months ]Ashworth Scale (AS) (Spasticity) Expanded Disability status scale (EDSS) SF 36
- Evaluation of the impact of spasticity on the quality of life of subjects with RRMS [ Time Frame: Initial visit (Day 0) to 24 months ]
- Evaluation of the changes in spasticity after 24 months [ Time Frame: Initial visit (Day 0) to 24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01080040
|Fundación Rosarina de Neurorehabilitación|
|Principal Investigator:||Dr. Jose A. Brizuela||Fundación Rosarina de Neurorehabilitación. Rosario, Argentina.|