Increasing Physical Activity in Recovered Persons With Multiple Sclerosis Through Daily Sensor Based Feedback and Weekly Focus Group Meetings: A Feasibility and Pilot II Study
The aim of htis study is to investigate the post intervention effects of daily feedback on actual physical activity levels derived from a wristworn accelerometer FITBIT combined with self-management training on in-clinic physical activity in persons with moderate to severe disability from MS.
NCT04186910 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT04186910/
The Reliability and Validity of the Functional Reach Test in Patients With Multiple Sclerosis
Loss of limits of stability ability is one of the major components of balance dysfunction in MS. The functional reach test is quick and clinically available tool for assessing limits of stability but reliability and validity of this test has not yet been systematically examined in people with Multiple Sclerosis.The aim of the study is to investigate reliability and validity of the functional reach test in patients with Multiple Sclerosis.
NCT04185688 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT04185688/
The Relationship Between Kinesiophobia, Physical Activity, Balance and Fear of Fall in Multiple Sclerosis Patients
Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating and neurodegenerative disease of the central nervous system (CNS). MS usually progresses with attacks, sequelae after attacks because it severely restricts the quality of life in patients and leads to progressive disability (Frohman et al., 2006). Balance and coordination problems, decreasing of physical activity level and fall disorders are observed in patients with MS (Confavreux et al., 2014). When the literature was examined, a relationship was found between kinesiophobia, quality of life, physical activity level and pain in stroke patients. Physical activity level, balance, fear of falling and kinesiophobia which are frequently seen in patients with MS have not been studied. In this study, the relationship between kinesiophobia, physical activity, balance and fear of fall in MS patients will be investigated.
NCT04183751 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT04183751/
Reliability and Validity of the Glittre Activities of Daily Living Test in Multiple Sclerosis Patients
Patients with Multiple Sclerosis (MS) have reduced functional capacity due to clinical symptoms of the disease, resulting in decreased participation in daily living activities and reduced quality of life. Evaluation of functional capacity and activities of daily living is very important in order to determine appropriate rehabilitation programs and increase the participation of patients in daily life activities. However, although there are many scales evaluating functional capacity and activities of daily living in people with disabilities, there is no specific assessment scale specific to MS patients. Therefore, this study was planned to investigate whether the Glittre Daily Living Activities (ADL) Test, which was developed to measure functional capacity in chronic obstructive pulmonary disease, is a valid and reliable measurement tool in MS patients. For this purpose, a total of 51 participants (25 MS patients and 26 healthy participants) evaluated with Glittre ADL Test. The relationship between Glittre ADL Test and 6-minute walk test, Notthingham Extended Daily Living Activities Index, Multiple Sclerosis Quality of Life Scale, Fatigue Severity Scale, Balance Assessment Systems Test (MiniBEST Test), Extended Disability Status Scale and 5-repetition sit-to-stand test evaluated with Pearson or Spearman correlation coefficient. For the known group validity, the difference between the patient and control groups compared with the test of the difference between the two means. For reliability, test retest performed. Reliability evaluated with the intraclass correlation coefficient. Hypothesis 1: Glittre ADL Test results in MS patients and healthy subjects are different. Hypothesis 2: Glittre ADL Test is reliable in MS patients. Hypothesis 3: Glittre ADL Test is valid for evaluating functional exercise capacity in MS patients.
NCT04182269 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT04182269/
Double-blinded, Randomized Controlled Trial of Simvastatin Use As Adjuvant Therapy in Relapsing-Remitting Multiple Sclerosis
The purpose of the clinical trial is to test how Simvastatin (80mg/day) may decrease attacks and progression of disease in patients with multiple sclerosis under disease modifying therapy (DMTs)
NCT04178980 — Simvastatin Multiple Sclerosis
Status: Not yet recruiting
http://inclinicaltrials.com/simvastatin-multiple-sclerosis/NCT04178980/
Training to Restore Walking and Promote Nervous System Repair in Multiple Sclerosis: RCT to Determine the Importance of Intensity
New research in animal models of MS suggests that greater training intensity is required to restore lost functions. We have developed and tested vigorous intensity cool room treadmill training that people with MS who have fatigue and heat-sensitivity can tolerate. This study will focus on the appropriate dosage of training.
NCT04175054 — Multiple Sclerosis
Status: Not yet recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT04175054/
Effects of a Semi-inmersive Virtual Reality Training Program on Muscle Strength, Coordination, Fatigue, Functionality and Quality of Life in Patients With Multiple Sclerosis
Video games based on VR technology are emerging as valid tools used in neurorehabilitation for patients with neurological disorders, and as a low cost and easily accepted adjunct to traditional therapy. Standard games such as the Nintendo Wii, Playstation Move and Kinect plus XBOX 360 have been used in EM rehabilitation. However, often these are either too difficult for patients or the games progress too quickly, failing to provide impairment-focused training or specifically address patients' needs [10]. Therefore, it is necessary to develop specific serious games for EM patients. Serious games are defined as games designed for a primary purpose other than that of pure entertainment, and which promote learning and behavior changes for EM patients. In this context, gesture caption devices (such as MYO, LEAP or Joy Con´s Nintendo Switch), which uses a sensor that captures the movement of the patient's forearms and hands are really interesting in rehabilitation contexts. This generates a virtual image of the upper limbs on a computer screen and the patient is prompted to perform movements according to the functional task proposed. This system presents important advantages namely thanks to its portability, ease of use, commercial availability, low cost and non-invasive nature. However, evidence is lacking that supports the therapeutic use of semi-inmersive VR technology in the treatment of upper limb (UL) motor disorders in EM.
NCT04171908 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT04171908/
Home-based EXergames To impRove cognitivE Function in MUltiple Sclerosis: the EXTREMUS Study. A Multicenter, Randomized, Single-blind Non-inferiority Trial
Study design: Phase II, multicenter, randomized, sham-controlled, single-blind, parallel arm, multicenter study to test the hypothesis that home-based exergames is not inferior to home-based cognitive rehabilitation delivered by a software application (app) for mobile devices and both interventions are superior to a placebo-analogue cognitive intervention in improving cognitive function and reducing cognitive-motor interference in people with multiple sclerosis (MS). Procedures: Participants will be randomized in a 1:1:1 ratio to receive an 8-week home-based training with exergames (intervention of interest) or adaptive COGNI-TRAcK (comparator intervention) or sham COGNI-TRAcK (placebo-analogue intervention). Study assessment will be done at study enrolment (baseline), at the end of the 8-week intervention period (immediate post-training, Week 8) and after 16 weeks from randomization (post-training follow-up, Week 16). Investigational interventions: 1. Exergames: home-based repetition of several games delivered by the Nintendo © Wii Balance Board, a commercial off-the-shelf video game console for re-training of balance and postural strategies 2. Adaptive COGNI-TRAcK: adaptive (i.e. automatic adjustment of tasks difficulty) working memory training delivered by a customized application software for mobile devices to self-administer at-home 3. Sham COGNI-TRAcK: non-adaptive (i.e. constant difficulty level) working memory training delivered by the same app as afore described Primary endpoint: changes at the Symbol Digit Modalities Test (SDMT), a measure of sustained attention and information processing speed. Secondary endpoint: changes at the BICAMS (z-scores), a brief, practical and universal assessment tool for cognitive impairment in MS. Additional endpoints: magnitude of cognitive-motor interference estimated as dual-task cost of balance and walking. Sample size estimation: The investigators estimated a pre-defined 8-point non-inferiority margin, based on a significant effect of the COGNI-TRAcK in inducing an about 8-point mean increase at SDMT score (with respect to a sham intervention). Accordingly, 35 participants per arm are required to ensure, with an approximately 85%-power level, that the lower limit of a one-side 95% confidence interval will be above the pre-defined non-inferiority margin. Therefore, considering also a drop-out rate of 25%, a total of 132 subjects should be enrolled.
NCT04169750 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT04169750/
Sexual Dysfunction in Patients With Relapsing Remitting Multiple Sclerosis and Associated Comorbidities
This work aims to: 1. Investigate and correlate Sexual Dysfunction in relapsing-remitting Multiple Sclerosis patients with specific focus on 1. Specific neurologic deficit. 2. Depressive symptoms. 3. Comorbid factors. 4. Fatigue symptoms. 2. To investigate the impact of Sexual dysfunction on Sexual Quality of Life (SQoL). 3. To search for possible gender difference.
NCT04157283 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT04157283/
Retinal Thickness as a Potential Biomarker of Neurodegeneration and Early Cognitive Impairment in Patients With Multiple Sclerosis
The aim of this study is to investigate the relationship between cognitive impairment and retinal nerve fiber layer & ganglion cell inner plexiform layer in MS.
NCT04153773 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT04153773/