Virtual Reality in Physical Therapy in Multiple Sclerosis

NCT04807738 | Completed

• 1 other identifier: 1983/21+4772/21 (G-21-02)
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• Tremor; 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)

• Tremor; 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)

• 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)

Secondary Outcomes (2)

• Multiple Sclerosis Impact Scale (MSIS-29) - change pre/post intervention

  Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)

• EQ-5D-3L-health questionnaire - change pre/post intervention

  Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)

Other Outcomes (5)

• Kinematic analysis

  Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)]

• Functional Magnetic Resonance Imaging

  Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)]

• MR tractography and Diffusion-Weighted Imaging

  Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)]

Study Arms (2)

Neuroproprioceptive "facilitation and inhibition"

ACTIVE COMPARATOR

ARM 1 - Neuroproprioceptive "facilitation and inhibition" physical therapy combining key principles of proprioceptive neuromuscular facilitation (PNF) and motor program activating therapy (MPAT), with former positive probative evidence on MS and are recommended for MS intervention.

Other: Neuroproprioceptive "facilitation and inhibition"

Neuroproprioceptive "facilitation and inhibition" in virtual reality

EXPERIMENTAL

ARM 2. Experimental group, neuroproprioceptive "facilitation and inhibition" physical therapy combining key principles of proprioceptive neuromuscular facilitation (PNF) and motor program activating therapy (MPAT) through virtual reality and software inducing and motivating for movement according to principles of proprioceptive neuromuscular facilitation (PNF) and motor program activating therapy (MPAT). We believe that the VR environment might lead to better results due to greater motivation effect, novelty effect, entertainment effect, as well as activating the reward system. We believe the VR might enhance the activation of mirror neurons, it might also activate proprioception. The present physiotherapist is to ensure proper execution of the tasks. The correlation of the two arms of the study should indicate, whether virtual reality and the software used are as effective, or more effective in sustaining the hand motor function and axial stability, than traditionally led therapy.

Device: Neuroproprioceptive "facilitation and inhibition" in virtual reality

Interventions

Neuroproprioceptive "facilitation and inhibition" in virtual reality DEVICE

The outpatients will be randomized into groups: 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 the interventional group, uses virtual reality and the 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.

Neuroproprioceptive "facilitation and inhibition" in virtual reality

Neuroproprioceptive "facilitation and inhibition" OTHER

The first arm of the study will undergo physical therapy with 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.

Neuroproprioceptive "facilitation and inhibition"

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (2)

Department of neurology

Prague, 100 00, Czechia

Location

Deparment of revmatology and rehabilitation

Prague, 140 59, Czechia

Location

Related Publications (1)

• Miznerova B, Reissigova J, Vasa L, Frank J, Hudec M, Rodina L, Herynkova A, Havlik J, Tintera J, Rydlo J, Ibrahim I, O'Leary VB, Cerna M, Jurickova I, Pokorna M, Philipp T, Hlinovska J, Stetkarova I, Rasova K. Virtual reality-based neuroproprioceptive physiotherapy in multiple sclerosis: a protocol for a double-arm randomised assessor-blinded controlled trial on upper extremity function, postural function and quality of life, with molecular and functional MRI assessment. BMJ Open. 2025 Jan 9;15(1):e088046. doi: 10.1136/bmjopen-2024-088046.

  PMID: 39788766 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Inhibition, Psychological; Autoimmune Diseases of the Nervous System

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Kamila Rasova, as.prof.Dr.

  Clinic of rheumatology and rehabilitation,Third medical faculty CU and Faculty Thomayer Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All participants of the study will undergo a clinical examination including a questionnaire survey, led by a blinded independent examiner, who will not have access to intervention documentation. The examiner will see each patient twice, before the first intervention and in follow-up examination in a week following the last therapy. The examiner will be prohibited to talk about the therapy attended. The patients will be informed about the character of the examination and the importance of the most objectivity possible. All therapists can apply both interventions, therefore masking is more efficient.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc. prof. PhDr.Kamila Řasová, Ph.D.

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 19, 2021
• Study Start: April 1, 2021
• Primary Completion: January 2, 2025
• Study Completion: February 1, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)