Semi-inmersive Virtual Reality on Upper Limb in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04171908
• Other study ID #: Virtual Arms-EM
• Status: Completed
• Phase: N/A
• Start date: November 12, 2019
• Est. completion date: April 11, 2023

Study information

• Verified date: June 2023
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 11, 2023
• Est. primary completion date: March 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Paresis
• Sclerosis
• Treatment Adherence
• Upper Extremity Paresis

Intervention

Other:
• Conventional therapy
Conventional Physical therapy for the upper limb
• semi-inversive tech
Conventional Physical therapy for the upper limb plus Semi-inversive tech

Locations

Country	Name	City	State
Spain	Roberto Cano de la Cuerda	Alcorcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Jamar	Hand-held dynamometer: it is an instrument to measure the maximumisometric strength of the hand and forearm muscles. It consists of a sealed hydraulic system with adjustable hand spacing that measures hand grip force. The strength reading can be viewed as pounds or kilograms.Thedynamometer is used for testing the hand grip force and for tracking the grip strength improvements during rehabilitation.	8 weeks
Primary	Box and blocks	Coordination test: to measure unilateral gross manual dexterity in both the less and more affected side. The Box and blocks consists of moving the maximum number of blocks from one compartment of a box to another, one by one, within one minute. The Box and blocks is a quick, simple, and reliable measurement of manual dexterity. Its administration procedure is standardized and its validity has been shown in elderly subjects with upper limb disability	8 weeks
Primary	The Purdue Pegboard Test	Motricity: to assess coordination, speed of movement and fine motor dexterity. The The Purdue Pegboard Test features a board with two columns with 25 holes each and a specific number of pins, washers and collars placed in four containers across the top of the board. The test consists of inserting as many pins as possible in three distinct phases, with a time limit of 30 s for each. First, the test is performed with the less affected side, then with the more affected side, then with both hands at the same time and, finally, an assembly test is performed (60 s). The number of pins inserted is subsequently recorded.	8 weeks
Primary	Nine Hole Peg Test	Motricity: It is a hand function test, which consists of a plastic peg board (25.0 cm × 12.7 cm × 2.3 cm) with nine holes (2.54 cm between the holes) and nine pegs (3.2 cm long, 0.64 cm wide). The participant had to put the nine pegs in the peg board as fast as possible, one at the time with one hand only, and remove them again. The test was performed two times per hand, with the non-affected hand first. The time it takes to fulfill the second trial with the more-affected hand was used for the analysis	8 weeks
Secondary	The Client Satisfaction Questionnaire	The Client Satisfaction Questionnaire was used to evaluate the satisfaction of health service users for both groups. This is a self-administered post-treatment questionnaire, comprising eight items which evaluate the level of satisfaction regarding the care and quality of the service received and the level of fulfillment of the patient's expectations regarding the treatment administered. The total score of the questionnaire is 32 points, with higher values meaning higher satisfaction with the treatment received	after 8 weeks of treatment
Secondary	Adherence	The attendance rate (%) for therapy sessions (compliance) will be registered	after 8 weeks of treatment