Multiple Sclerosis Clinical Trial
— VIREMSOfficial title:
Effect of Neuroproprioceptive "Facilitation, Inhibition" Physical Therapy Using Virtual Reality on Upper Limb Mobility and Postural Stability in Multiple Sclerosis
The randomized controlled trial is aimed to study the efficacy of virtual reality (VR) and its impact on upper limb function and postural stability in people with mild to severe multiple sclerosis (pwMS). The conceptual idea is to compare two kinds of neuroproprioceptive "facilitation and inhibition" physical therapy, first in a real environment and second in virtual reality, in out-patient therapy that will be held in 15 hourly therapies, 2x a week in a period of two months. The efficacy will be assessed by a blinded independent clinical examiner using clinical examination and questionnaire survey before and in a week following the therapeutic intervention. The main focus is on upper limb gross and fine motor skills, trunk stability and stability, and sit to stand stability.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | July 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - The inclusion criteria comprise of a definite diagnosis of multiple sclerosis, EDSS score = 2 a = 7 ((10); determined by neurologist), no history of relapse, no history of change in disease-modifying treatment, no history of corticosteroid therapy in the past three months prior to recruitment. Exclusion Criteria: - The exclusion criteria include other factors influencing mobility (history of stroke, pregnancy, traumatic injury of limb/s. Severe cardiovascular or orthopedic dysfunction, impaired cognitive functions in the course of examination and/or consecutive therapy. |
Country | Name | City | State |
---|---|---|---|
Czechia | Deparment of revmatology and rehabilitation | Prague | |
Czechia | Department of neurology | Prague |
Lead Sponsor | Collaborator |
---|---|
Charles University, Czech Republic |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Functional Magnetic Resonance | The fMRI examinations shall be performed in the MR system Siemens Vida 3T located in IKEM using a 64-channel RF head coil. Examination protocol will include essential structural imaging (3D SPACE FLAIR sequence with an isotropic spatial resolution of 1 mm3), measurement of functional connectivity using resting-state fMRI, and measurement of structural connectivity utilising the evaluation of the spatial distribution of molecular diffusion (generalised DTI - diffusion tensor imaging, with 108 spatial directions and 3b-factors allowing the reconstruction not only of fractional anisotropy but also the diffusion kurtosis imaging). The resting of 30 seconds will be followed by a 30-second unilateral hand active movement-driven stimulation interval, repeated eight times. | Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)] | |
Other | Biomarkers from peripheral blood: lncRNA and dendritic cell activation | The study will include an analysis of long non-coding RNA (lncRNA), the subtypes, and the activation of dendritic cells. The dynamic of the studied parameters might bring essential knowledge on the biological effect of rehabilitation intervention in people with multiple sclerosis. These parameters will be studied and correlated concerning individual MS treatment. | Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)] | |
Other | Brief ICF core set for Multiple Sclerosis | For more systematic patient population characteristics and monitoring of individual levels of functioning, disability and health, we will obtain information from the Brief ICF core set for Multiple Sclerosis, the official core set by the ICF Research Branch. | Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)] | |
Primary | Nine Hole Peg Test (9HPT) - change pre/post intervention | The NHPT requires participants to repeatedly place and then remove nine pegs into nine holes, one at a time, as quickly as possible. Lower number (quicker time) means better result. | Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure) | |
Primary | Box and Block Test (BNB) - change pre/post intervention | The Box and Block Test tests gross manual dexterity. This test consists of moving, one by one, the maximum number of blocks from one compartment of a box to another of equal size, originally, within 60 seconds. A lower number (quicker time) means better result. | Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure) | |
Primary | Five times Sit to Stand test (5STS) -change pre/post intervention | The test assesses time when people stand and sit repeatedly five times. The lower the time to complete the test the better the outcome of the test. | Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure) | |
Primary | Hand Grip Strength (HGS) -change pre/post intervention | Jamar Hydraulic Hand Dynamometer measures isometric grip force and strength. The higher value, the better function (higher strength). | Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure) | |
Primary | Frequency for which the smoothed power spectral density is maximal (fMAX) | The spectral characteristic of postural tremor measured by the 3-axis accelerometer and 3-axis gyroscope chip (Motion Tracking sensor MPU-6050) - lower value, lower tremor. | Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure) | |
Primary | Power of the signal in band from f1 to f2 (Pf1-f2) | The spectral characteristic of postural tremor measured by the 3-axis accelerometer and 3-axis gyroscope chip (Motion Tracking sensor MPU-6050) - lower value, lower tremor. | Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure) | |
Secondary | Multiple Sclerosis Impact Scale (MSIS-29) - change pre/post intervention | A 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on a day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5" extremely". Each of the two scales is scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates the greater impact of the disease on daily function (worse health). | Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure) | |
Secondary | EQ-5D-3L-health questionnaire - change pre/post intervention | Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain & discomfort, Anxiety & depression), each of which has three severity levels that are described by statements appropriate to that dimension. A higher number means a worse quality of life. | Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05528666 -
Risk Perception in Multiple Sclerosis
|
||
Completed |
NCT03608527 -
Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
|
N/A | |
Recruiting |
NCT05532943 -
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
|
Phase 1/Phase 2 | |
Completed |
NCT02486640 -
Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
|
||
Completed |
NCT01324232 -
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT04546698 -
5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
|
||
Active, not recruiting |
NCT04380220 -
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
|
||
Completed |
NCT02835677 -
Integrating Caregiver Support Into MS Care
|
N/A | |
Completed |
NCT03686826 -
Feasibility and Reliability of Multimodal Evoked Potentials
|
||
Recruiting |
NCT05964829 -
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
|
N/A | |
Withdrawn |
NCT06021561 -
Orofacial Pain in Multiple Sclerosis
|
||
Completed |
NCT03653585 -
Cortical Lesions in Patients With Multiple Sclerosis
|
||
Recruiting |
NCT04798651 -
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
|
N/A | |
Active, not recruiting |
NCT05054140 -
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT05447143 -
Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis
|
N/A | |
Recruiting |
NCT06195644 -
Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients
|
Phase 1 | |
Completed |
NCT04147052 -
iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis
|
N/A | |
Completed |
NCT03594357 -
Cognitive Functions in Patients With Multiple Sclerosis
|
||
Completed |
NCT03591809 -
Combined Exercise Training in Patients With Multiple Sclerosis
|
N/A | |
Completed |
NCT03269175 -
BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies
|
Phase 4 |