Virtual Reality in Physical Therapy in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— VIREMS  

Official title:

Effect of Neuroproprioceptive "Facilitation, Inhibition" Physical Therapy Using Virtual Reality on Upper Limb Mobility and Postural Stability in Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04807738
• Other study ID #: 1983/21+4772/21 (G-21-02)
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: July 2025

Study information

• Verified date: February 2023
• Source: Charles University, Czech Republic
• Contact: Barbora Miznerova, M.D.
• Phone: +420776480210
• Email: blahutovabarbora[@]seznam.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

In 60 - 75% of people with multiple sclerosis (MS) an upper limb mobility dysfunction (unilateral or bilateral manual dexterity, sensibility impairment, tremor) is present, resulting in reduced participation in activities of daily living. Physiotherapy has a crucial impact on upper limb mobility, although there are many approaches applied (exercise/strengthening exercise, endurance training, sensory training, constraint-induced movement therapy, robotic rehabilitation therapy, etc.). Virtual reality is an innovative technological concept using game mechanisms that facilitate concentration and motivation in task performance. Current research implies that VR is a safe and effective method in gait and balance//stability rehabilitation therapy and with less evidence, for upper limb mobility improvement. It is expected that a greater therapeutic effect is a result of multifactorial sense stimulation and dopamine centres in the brain. A pilot project showed that virtual reality without the prompt feedback of a physiotherapist is not more effective than standard therapy. A new therapeutic software using virtual reality spontaneously motivating the patient for movement realization was developed in cooperation with the Department of informatics and computer science Faculty of applied sciences University West Bohemia. Accurate execution of neuroproprioceptive "facilitation and inhibition techniques" physical therapy combining key principles from proprioceptive neuromuscular stabilization (PNS) and motor program activating therapy (MPAT), ensures a present physiotherapist. These principles have shown the effect in therapy in pwMS. Participants will be randomized into two arms of the study, both implementing neuroproprioceptive "facilitation and inhibition" physical therapy, first in a real environment and second in VR. The investigators expect that VR intervention shall improve upper limb motor functions, trunk muscles coordination, improve the performance of activities of daily living and quality of life in pwMS more than identical therapy not using VR. The effect of both interventions will be assessed using validated tests for clinical examination- Five times Sit to Stand test (5STS), Nine Hole Peg Test (9HPT), Hand Grip Strength (HGS), Box and Block Test (BNB), accelerometer for tremor examination. Validated questionnaires will be used, specifically the Multiple Sclerosis Impact Scale (MSIS-29), EQ-5D-3L health questionnaire, Visual Analogue Scale, and a questionnaire dealing with individual virtual reality intervention evaluation.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Neuroproprioceptive "facilitation and inhibition" in virtual reality
The 110 outpatients will be randomized into groups: First arm, individual neuroproprioceptive "facilitation and inhibition" physical therapy combining key principles of proprioceptive neuromuscular facilitation (PNF) and motor program activating therapy (MPAT) in a real environment and the second arm, the same therapy in virtual reality environment. All participants will undergo 15 sessions, 60 minutes each, twice a week in a period of two months. The therapy in a second, interventional group, uses virtual reality and new software that was developed specifically for inducing and motivating for movement according to principles of proprioceptive neuromuscular facilitation (PNF) and motor program activating therapy (MPAT). The software allows immediate feedback and moreover, movement is corrected by a present therapist. Evaluation of speed and performance quality might be extracted from the software of virtual reality.

Other:
• Neuroproprioceptive "facilitation and inhibition"
The first arm of the study will consist of a physiotherapeutic approach based on neurophysiological principles using proprioceptive neuromuscular facilitation (PNF) and motor program activating therapy (MPAT) approaches. MPAT makes use of particular motor patterns that evolve in postural control development. The repetition of activated programs, a set of stimuli, applied to change the posture with anatomical centration of the joint under various conditions in leading to better support of postural stabilization while seated, while getting up, stepping forward, and standing, in order to teach the patients to use the acquired motor skills automatically in daily life. PNF is a method used for learning effective movement patterns with high biomechanical effectiveness based on repetitive stimulation of cooperating alfa-motoneurons and proprioceptors in muscle, tendons and joint capsules. Therapy will be individualized and led in the standard face-to-face regiment.

Locations

Country	Name	City	State
Czechia	Deparment of revmatology and rehabilitation	Prague
Czechia	Department of neurology	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

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)