Semi-inmersive Virtual Reality on Upper Limb in Multiple Sclerosis

NCT04171908 | Completed DMC

• 1 other identifier: Virtual Arms-EM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Treatment Adherence; Upper Extremity Paresis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

• The Client Satisfaction Questionnaire

  after 8 weeks of treatment

• Adherence

  after 8 weeks of treatment

Study Arms (2)

Conventional therapy

ACTIVE COMPARATOR

Conventional Physical therapy for the upper limb

Other: Conventional therapy

semi-inmersive VR technology plus conventional therapy

EXPERIMENTAL

Conventional Physical therapy for the upper limb plus semi-inmersive VR technology

Other: semi-inversive tech

Interventions

Conventional therapy OTHER

Conventional Physical therapy for the upper limb

Conventional therapy

semi-inversive tech OTHER

Conventional Physical therapy for the upper limb plus Semi-inversive tech

semi-inmersive VR technology plus conventional therapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Roberto Cano de la Cuerda

Alcorcón, Madrid, 28922, Spain

Location

Related Publications (4)

• Marcos-Anton S, Cano-de-la-Cuerda R, Aranda-Reneo I, Jardon-Huete A, Ona-Simbana ED, Oliva-Moreno J. Cost-effectiveness analysis of the MYO Armband(R) device in combination with specifically designed video games for upper limb rehabilitation in people with multiple sclerosis. J Neuroeng Rehabil. 2025 Nov 27. doi: 10.1186/s12984-025-01801-x. Online ahead of print.

  PMID: 41299524 DERIVED

• Marcos-Anton S, Jardon-Huete A, Ona-Simbana ED, Blazquez-Fernandez A, Martinez-Rolando L, Cano-de-la-Cuerda R. sEMG-controlled forearm bracelet and serious game-based rehabilitation for training manual dexterity in people with multiple sclerosis: a randomised controlled trial. J Neuroeng Rehabil. 2023 Aug 19;20(1):110. doi: 10.1186/s12984-023-01233-5.

  PMID: 37598176 DERIVED

• 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.

  PMID: 35743333 DERIVED

• 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.

  PMID: 32660604 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Treatment Adherence and Compliance; Paresis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Health Behavior; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full proffesor

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 21, 2019
• Study Start: November 12, 2019
• Primary Completion: March 11, 2023
• Study Completion: April 11, 2023
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)