Virtual Reality and Manual Dexterity in in Patients With Multiple Sclerosis

NCT03186612 | Unknown DMC

• 1 other identifier: UniversidadRJC
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction. Multiple sclerosis (MS) is the most common neurological disease causing disability in young adults. Neurorehabilitation is a fundamental aspect in the treatment approach for MS, in which new technologies have gained popularity, especially the use of virtual reality (VR), thanks to the therapeutic possibilities offered for patients with MS presenting cognitive, sensitive and motor dysfunctions. Aim. To analyze and compare an occupational therapy intervention (OT) compared with OT + VR (OT+VR) on the manual dexterity of patients with MS. Material and methods. 26 patients will be recruited. The control group (n=8) will recieve 20 conventional OT sessions distributed in two sessions per week. The experimental group OT+VR (n=8) will recieve 20 sessions of VR interventions, twice weekly and lasting 30 minutes, consisting of VR games accessed via the online webpage motiongamingconsole.com, including Flip Out, Air Hockey, Partículas, Dunkit, Cuenta peces and Robo Maro, in addition to the conventional OT sessions. Pre and post-intervention assessments will be based on the Purdue Pegboard Test, the Jebsen Taylor Hand Function Test and the Grooved Pegboard Test.

Conditions

Multiple Sclerosis; Physical Activity; Upper Limb; Virtual Reality; Dexterity

Keywords

Video games; Virtual reality; Occupational therapy, Manual dexterity; Multiple sclerosis.

Outcome Measures

Primary Outcomes (3)

• Manual dexterity, gross dexterity and coordination

  It will be used Purdue Pegboard Test (PPT) for the assessment gross dexterity and coordination. This test assesses the speed and motor dexterity of each hand and the manual dexterity using both hands at the same time. The PPT consists of 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 seconds for each part. First, the test is performed with the dominant hand, then with the non-dominant hand and then with both hands at the same time. The number of pins inserted is recorded.

  2 mothns and 15 days between assessments. The "change" that it is being assessed is fine manual dexterity

• Hand´s functional capacity

  The Jebsen Taylor Hand Function Test (JTT) will be used to determine the hand's functional capacity. This test is timed and divided in seven parts. The seven subtests are: writing, page turning, picking up small common objects, simulated feeding, stacking checkers, moving large light objects and moving large heavy objects. All the subtests are performed with the dominant hand first, followed by the dominant hand. The time the subject takes to perform each subtest is recorded.

  2 mothns and 15 days between assessments. The "change" that it is being assessed is hand's functional status

• Manipulative dexterity

  The Grooved Pegboard Test (GPT) is a test that evaluates manipulative dexterity. This test is performed with the dominant hand and consists of inserting pegs in the slots of a board which are placed at different angles. The score is the time in seconds required for inserting all the pegs.

  2 mothns and 15 days between assessments. The "change" that it is being assessed is manipulative dexterity

Study Arms (2)

OT intervention

ACTIVE COMPARATOR

Conventional occupational therapy (OT) treatment will consist of 20 sessions in total, during which subjects will perform activities for training manipulative and functional dexterity of the upper limb aimed at activities of daily living. These will be distributed in two OT sessions per week, each lasting 30 minutes.

Behavioral: OT+VR intervention with videogames for the upper limb (dexterity)

OT+VR intervention

EXPERIMENTAL

The intervention applied to the experimental group will consist of 20 sessions of conventional OT distributed in two sessions per week, each lasting 30 minutes. Additionally, they will receive 20 treatment sessions lasting 20 minutes, twice weekly of virtual reality (VR) via the online and free website motiongamingconsole.com, during which they will performe exercises with video capture of the upper limb movements via the performance of functional and manual dexterity activities based on the following games: Flip Out, Air Hockey, Particlesículas, Dunkit, Cuenta PecesCounting fishes and Robo Maro. All the interventions will consider the level of fatigue experimented by the patient by featuring a progressive increase of the treatment times according to the same.

Behavioral: OT+VR intervention with videogames for the upper limb (dexterity)

Interventions

OT+VR intervention with videogames for the upper limb (dexterity) BEHAVIORAL

Patients will performe exercises with video capture of the upper limb movements via the performance of functional and manual dexterity activities based on the following games: Flip Out, Air Hockey, Particlesículas, Dunkit, Cuenta PecesCounting fishes and Robo Maro.

OT intervention; OT+VR intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a diagnosis of MS according to the McDonald criteria with over two years evolution;
• a score of between 3.5 (moderate incapacity, although totally ambulant and able to be self-sufficient and active during 12 hours of a day) and six (requires constant help, either unilateral or intermittently with a walking stick or crutches, in order to walk approximately 100 meters with, or without, a rest) on the Kurtzke Expanded Disability Status Score (EDSS) with;
• stable medical treatment during, at least the six months prior to the intervention;
• muscle tone in the upper limbs not greater than two points on the modified Ashworth Scale (moderate hypertonia, increased muscle tone through most of the range of movement, but affected part easily moved);
• as well as a score of four points or less in the "Pyramidal Function" section of the EDSS functional scale;
• absence of cognitive decline; with the ability to understand instructions and obtaining a score of 24 or more in the Minimental Test;
• as well as a score of two points or less in the "Mental Functions" section of the EDSS.

You may not qualify if:

• the diagnosis of another neurological illness or musculoskeletal alteration different to MS;
• the diagnosis of a cardiovascular, respiratory or metabolic illness, or other conditions which may interfere with the study;
• suffering a flare-up or hospitalization in the last three months prior to commencement of the assessment protocol, or during the process of the therapeutic intervention;
• receiving a cycle of steroids, either intravenously or oral, six months prior to the commencement of the assessment protocol and within the study period of intervention;
• receiving treatment with botulinum toxin in the six months prior to the beginning of the study; or the presence of visual disorders non-corrected by optical devices.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Roberto Cano de la Cuerda

Alcorcón, Madrid, 28922, Spain

RECRUITING

Related Publications (1)

• Ortiz-Gutiérrez R, Galán del Río F, Cano de la Cuerda R, Alguacil Diego IM, Arroyo-González R, Miangolarra-Page JC.A telerehabilitation program by virtual reality-video games improves balance and postural control in multiple sclerosis patients. NeuroRehabilitation. 2013; 33(4):545-54. Ortiz-Gutiérrez R, Cano-de la Cuerda R, Galán-del Río F, Alguacil-Diego IM, Palacios-Ceña D, Miangolarra-Page JC. A telerehabilitation program improves postural control in multiple sclerosis patients. A Spanish preliminary study. Int J Environ Res Public Health 2013;10(11):5697-710 Palacios-Ceña D, Ortiz-Gutierrez R, Buesa-Estellez A, Galán-del-Río F, Cachón- Pérez JM, Martinez-Piédrola R, Velarde-García JF, Cano-de-la-Cuerda R. Multiple sclerosis patients' experiences in relation to the impact of the kinect virtual home- exercise programme: a qualitative study. Eu J Phys Rehabil Med 2016;52(3):347-55. Shin JH, Kim MY, Lee JY, Jeon YL, Kim S, Lee S, Seo B, Choi Y. Effects of virtual reality-based rehabilitation on distal upper extremity function and health-related quality of life: a single-blinded, randomized controlled trial. J Neuroeng Rehabil. 2016; 13:17.

  BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Roberto Cano de la Cuerda, PhD

  Universidad Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Cano de la Cuerda, PhD

CONTACT

+00914888674; roberto.cano@urjc.es

Cristina Gómez Calero, PhD

CONTACT

+00914888674; cristina.gomez@urjc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All assessments were conducted by masked evaluators. They were not related to the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: It will be conducted a blinded randomized controlled trial (RCT). Non-probabilistic sampling of consecutive cases will be used.

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 14, 2017
• Study Start: March 2, 2016
• Primary Completion: December 2, 2017
• Study Completion: December 31, 2017
• Last Updated: June 16, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)