Impact of Virtual Reality Physiotherapy on Multiple Sclerosis Patients
ConditionMultiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEuropean University of Madrid
About this trial
The goal of this clinical trial is to learn if virtual reality combined with conventional physiotherapy intervention works to treat moderate to severe multiple sclerosis persons. The main questions it aims to answer are:
* Does the application of a virtual reality-based program along with conventional physiotherapy produces improvements compared to the application of conventional physiotherapy and placebo virtual reality in motor aspects of patients with multiple sclerosis? * Does the application of a virtual reality-based program along with conventional physiotherapy produces improvements compared to the application of conventional physiotherapy and placebo virtual reality in cognitive aspects of patients with multiple sclerosis
Researchers will compare a virtual reality-based program along with conventional physiotherapy with a placebo virtual reality to see if virtual reality improve motor and cognitive aspects of multiple sclerosis.
Participants will:
* Visit the clinic twice a week for 10 weeks to receive a 1-hour session of virtual reality and conventional physiotherapy. * Be assessed using various scales and questionnaires at three different times: at the start of the study, at the end of the treatment, and 4 weeks after the study ends.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed diagnosis of Multiple Sclerosis based on McDonald criteria, with an evolution time of more than two years.
All patients with Multiple Sclerosis are included according to the Kurtzke Multiple Sclerosis Disability Status Scale (EDSS) (ANNEX II) with a score greater than or equal to 6.5 (Need of two types of support to walk -two canes, walker...- about 20 meters without resting).
Stable medical treatment for at least six months prior to intervention.
Absence of cognitive impairment, with ability to understand instructions and to obtain a score equal to or greater than 24 on the Minimental Test.
Disqualifiers
Diagnosis of another neurological disease or musculoskeletal disorder other than MS.
Diagnosis of any cardiovascular, respiratory or metabolic disease, or other conditions that may interfere with this study.
To have suffered an exacerbation or hospitalization in the last 3 months before starting the assessment protocol, nor during the therapeutic intervention process.
To have received a course of steroids, intravenously or orally, 6 months prior to the start of the assessment protocol and within the intervention period of the study duration.
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality group
Other interventionVirtual reality group will perform online reality-based device following a therapeutic protocol supervised by a physiotherapist in which the level of demand will be adjusted to the patient's evolution. This programme provides a gamified and challenging online environment to enhance motor learning and induce sensorimotor adaptations. Additionally, they will receive conventional physiotherapy approach, oriented to the specific objectives of each patient, aiming to normalize tone, activate weakened muscles, facilitate movement, recover sensitivity, and compensate for functional deficits. Additionally, global kinesitherapy, motor coordination exercises, pedalier, vibration therapy (vibrosphere®), and analgesic electrotherapy will be performed if necessary.
Placebo virtual reality group
Other interventionThe control group will undergo a conventional physiotherapy program based on the normalization of tone, activation of weakened muscles and facilitation of normal movement, recovery of alterations in sensitivity, and compensation of lost functional deficits. In addition, global kinesitherapy exercises will be performed on a stretcher, motor coordination exercises, pedalier, vibration therapy (vibrosphere ®) and analgesic electrotherapy if necessary. Finally, in order to minimize the differences between the control and intervention groups, the participants of the control group will watch a 15-minute generic 2D video freely accessible on the Youtube platform from the VR glasses, without specific software.
Treatment groups
26 Participants
are divided into 2 treatment groupsGroup A: Virtual Reality groupExperimental treatment 1 intervention
Group B: Placebo Virtual reality groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in fatigue impact as measured with Modified Fatigue Impact Scale (MFIS)
Modified Fatigue Impact Scale is a self-report questionnaire designed to assess the impact of fatigue on patients with multiple sclerosis (MS). It evaluates how fatigue affects physical, cognitive, and psychosocial functioning on daily life in MS patients. The MFIS consists of 21 items divided into three subscales: physical, cognitive, and psychosocial. Higher scores indicate a greater impact of fatigue. The total score is the sum of all item scores, with subscale scores calculated separately. The administration time is approximately 5-10 minutes. It is typically self-administered, but can be conducted as an interview if necessary.
Time frame
The first measurement time will be at the beginning of the study, the second at the end of the 10-week intervention, and the third a follow-up 4 weeks later.Secondary outcomes
1
Change in Physical and psicological impact of Multiple Sclerosis on patients'life measured with Multiple Sclerosis Impact Scale (MSIS-29)
MSIS-29 is patient-reported outcome measure designed to assess the physical and psychological impact of multiple sclerosis on patients' lives. It consists of 29 items divided into two subscales: * Physical Impact (20 items): Evaluates the physical limitations and challenges faced by MS patients. * Psychological Impact (9 items): Assesses the emotional and cognitive effects of MS. Each item is rated on a scale, with higher scores indicating a greater impact of MS. The total score is the sum of the physical and psychological subscale scores. The administration Time is approximately 10-15 minutes. It can be self-administered or conducted as an interview.
Time frame
The first measurement time will be at the beginning of the study, the second at the end of the 10-week intervention, and the third a follow-up 4 weeks later.2
Change in manual dexterity and fine motor skills
It will be measured using the Purdue Pegboard TEST (PPT). It is a performance-based assessment used to measure manual dexterity and fine motor skills. Assesses fine motor skills and coordination of the fingers, hands, and arms. The test involves a rectangular board with two sets of 25 holes and four concave cups at the top. Participants are asked to place small metal pegs into the holes as quickly as possible. The test includes five subtests: right hand, left hand, both hands, right + left + both hands (a calculated score), and an assembly task. Each subtest is timed, typically 30 seconds for the hand tasks and 60 seconds for the assembly task. The administration time is approximately 5-10 minutes. It will be conducted by a test administrator. The participant is seated during the test.
Time frame
The first measurement time will be at the beginning of the study, the second at the end of the 10-week intervention, and the third a follow-up 4 weeks later.3
Change in gross motor manual dexterity
It will be evaluated through the Box and Block Test (BBT). It is designed to assess gross manual dexterity by measuring the ability to move small blocks from one compartment to another.The test involves a rectangular box divided into two equal compartments by a partition. One hundred and fifty small wooden blocks (2.5 cm each) are placed in one compartment. Participants are instructed to move as many blocks as possible, one at a time, from one compartment to the other within a 60-second period. The score is the number of blocks successfully transferred within the time limit. Higher scores indicate better manual dexterity. The administration time is approximately 2-5 minutes. The test will be administered with the participant seated at a table, and it will be conducted by a clinician or researcher.
Time frame
The first measurement time will be at the beginning of the study, the second at the end of the 10-week intervention, and the third a follow-up 4 weeks later.4
Change in functional independence to perform activities of daily living
It will be assessed using The Barthel Index (BI). It assesses the ability to perform activities of daily living (ADLs) independently. Evaluates the degree of assistance required by an individual to perform 10 basic ADLs, including feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfers (e.g., from chair to bed), mobility, and stair climbing. The index consists of 10 items, each scored on a scale that reflects the level of independence. The total score ranges from 0 to 100, with higher scores indicating greater independence. Each activity is scored based on the amount of assistance required, with possible scores of 0 (dependent), 5 (needs some help), or 10 (independent) for most items. The total score is the sum of the individual item scores.The administration time is approximately 5-10 minutes. It can be administered through direct observation, patient self-report, or interviews with caregivers.
Time frame
The first measurement time will be at the beginning of the study, the second at the end of the 10-week intervention, and the third a follow-up 4 weeks later.Sponsors and contacts
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Source ClinicalTrials.gov