Clinical trial NCT04171908: Semi-inmersive Virtual Reality on Upper Limb in Multiple Sclerosis
Official title: Effects of a Semi-inmersive Virtual Reality Training Program on Muscle Strength, Coordination, Fatigue, Functionality and Quality of Life in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Treatment Adherence
Upper Extremity Paresis
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Video games based on VR technology are emerging as valid tools used in neurorehabilitation for patients with neurological disorders, and as a low cost and easily accepted adjunct to traditional therapy. Standard games such as the Nintendo Wii, Playstation Move and Kinect plus XBOX 360 have been used in EM rehabilitation. However, often these are either too difficult for patients or the games progress too quickly, failing to provide impairment-focused training or specifically address patients' needs \[10\]. Therefore, it is necessary to develop specific serious games for EM patients. Serious games are defined as games designed for a primary purpose other than that of pure entertainment, and which promote learning and behavior changes for EM patients. In this context, gesture caption devices (such as MYO, LEAP or Joy Con´s Nintendo Switch), which uses a sensor that captures the movement of the patient's forearms and hands are really interesting in rehabilitation contexts. This generates a virtual image of the upper limbs on a computer screen and the patient is prompted to perform movements according to the functional task proposed. This system presents important advantages namely thanks to its portability, ease of use, commercial availability, low cost and non-invasive nature. However, evidence is lacking that supports the therapeutic use of semi-inmersive VR technology in the treatment of upper limb (UL) motor disorders in EM.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of MS according to McDonald's criteria.
* Assessment on the Kurtzke Scale of the State of Multiple Sclerosis Disability (EDSS) with a score between 1.0 and 7.5.
* Stable medical treatment for at least six months prior to the intervention.
* Muscle tone in the upper extremities not greater than 2 points (moderate hypertonia, increased muscle tone during most of the arc of movement, but the affected part can easily be moved passively) on the modified Ashworth Scale.
* Score less than or equal to 4 points in the section ¨Piramidal Function¨ of the functional scale of the EDSS.
* Absence of cognitive impairment, with the ability to understand the instructions and obtain a score equal to or greater than 24 in the Minimental Test.
* Score equal to or less than 2 points in the section ¨Functions Mental¨ of the EDSS.

Exclusion Criteria:

* Diagnosis of another neurological disease or musculoskeletal disorder other than MS.
* Diagnosis of any cardiovascular, respiratory or metabolic disease.
* Other conditions that may interfere with this study, having suffered an exacerbation or hospitalization in the last 3 months before starting the protocol of assessment, or during the therapeutic intervention process.
* Having received a steroid cycle, intravenously or orally, 6 months before the start of the assessment protocol and within the intervention period of study duration.
* Having received treatment with botulinum toxin in the six months prior to the start of the study.
* Presence of uncorrected visual disturbances through eye devices.

Primary outcomes:
measure: Jamar
timeFrame: 8 weeks
measure: Box and blocks
timeFrame: 8 weeks
measure: The Purdue Pegboard Test
timeFrame: 8 weeks
measure: Nine Hole Peg Test
timeFrame: 8 weeks
Secondary outcomes:
measure: The Client Satisfaction Questionnaire
timeFrame: after 8 weeks of treatment
measure: Adherence
timeFrame: after 8 weeks of treatment
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Roberto Cano de la Cuerda
state: Madrid
Study officials:
References:
citation: Cuesta-Gomez A, Martin-Diaz P, Sanchez-Herrera Baeza P, Martinez-Medina A, Ortiz-Comino C, Cano-de-la-Cuerda R. Nintendo Switch Joy-Cons' Infrared Motion Camera Sensor for Training Manual Dexterity in People with Multiple Sclerosis: A Randomized Controlled Trial. J Clin Med. 2022 Jun 7;11(12):3261. doi: 10.3390/jcm11123261.
citation: Cuesta-Gomez A, Sanchez-Herrera-Baeza P, Ona-Simbana ED, Martinez-Medina A, Ortiz-Comino C, Balaguer-Bernaldo-de-Quiros C, Jardon-Huete A, Cano-de-la-Cuerda R. Effects of virtual reality associated with serious games for upper limb rehabilitation inpatients with multiple sclerosis: randomized controlled trial. J Neuroeng Rehabil. 2020 Jul 13;17(1):90. doi: 10.1186/s12984-020-00718-x.