Clinical trial NCT04807738: Virtual Reality in Physical Therapy in Multiple Sclerosis
Official title: Effect of Neuroproprioceptive "Facilitation, Inhibition" Physical Therapy Using Virtual Reality on Upper Limb Mobility and Postural Stability in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
virtual reality
hand dexterity
postural stability
physical therapy
coordination
upper limb fine motor skills
motor programme activating therapy
neuroproprioceptive "facilitation, inhibition"
postural control
functional recovery
Demyelinating Autoimmune Disease
Autoimmune Diseases of the Nervous System
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial. 110 outpatients will be randomized into two interventional groups, one with face-to-face individual neuroproprioceptive "facilitation and inhibition" physical therapy combining key principles of proprioceptive neuromuscular facilitation (PNF) and motor program activating therapy (MPAT). The second arm will place the same therapy, but virtual reality environment. Participants of both groups - active comparator and virtual reality interventional group will undergo 15 hourly therapies, twice a week in a time range of two months. Before and in a week following the last therapy, all participants will be examined by a blinded independent clinician.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Nine Hole Peg Test (9HPT) - change pre/post intervention
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)
measure: Box and Block Test (BNB) - change pre/post intervention
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)
measure: Hand Grip Strength (HGS) -change pre/post intervention
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)
measure: Tremor; Frequency for which the smoothed power spectral density is maximal (fMAX)
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)
measure: Tremor; Power of the signal in band from f1 to f2 (Pf1-f2)
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)
measure: Five times Sit to Stand test (5STS) -change pre/post intervention
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)
Secondary outcomes:
measure: Multiple Sclerosis Impact Scale (MSIS-29) - change pre/post intervention
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)
measure: EQ-5D-3L-health questionnaire - change pre/post intervention
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)
Other outcomes:
measure: Kinematic analysis
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)]
measure: Functional Magnetic Resonance Imaging
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)]
measure: MR tractography and Diffusion-Weighted Imaging
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)]
measure: Monocyte-Derived Dendritic Cells
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)]
measure: Analysis of Long Non-Coding RNA (real-time Quantitative PCR)
timeFrame: Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)]
Locations:
city: Prague
country: Czechia
facility: Department of neurology
city: Prague
country: Czechia
facility: Deparment of revmatology and rehabilitation
Study officials:
affiliation: Clinic of rheumatology and rehabilitation,Third medical faculty CU and Faculty Thomayer Hospital
name: Kamila Rasova, as.prof.Dr.
role: STUDY_DIRECTOR
References: