Clinical trial NCT03186612: Virtual Reality and Manual Dexterity in in Patients With Multiple Sclerosis
Official title: Effects of a Game-based Virtual Reality Video Capture Training Program Plus Occupational Therapy on Manual Dexterity in Patients With Multiple Sclerosis: a Randomizaed Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Physical Activity
Upper Limb
Virtual Reality
Dexterity
Keywords: Video games; Virtual reality; Occupational therapy, Manual dexterity; Multiple sclerosis.
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It will be conducted a blinded randomized controlled trial (RCT). Non-probabilistic sampling of consecutive cases will be used.
Primary purpose: TREATMENT

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.

Detailed description: Multiple sclerosis (MS) is a chronic inflammatory demyelinating illness of the central nervous system (CNS) of unknown etiology and a multifactorial origin. Currently, MS represents the most common neurological illness that causes disability among young adults in Europe and North America.

The symptoms depend on the areas of the CNS that are injured, with considerable clinical variability between patients, depending on the level of severity and the duration of the disease. Among the most common symptoms, patients exhibit fatigue, visual disorders, problems affecting balance and coordination, sensitivity disorders, spasticity, cognitive and emotional disorders, speech disorders, problems affecting the bladder and intestines, as well as sexual related dysfunction.

Different disease courses exist for MS, according to the appearance of symptoms, such as relapsing-remitting MS, primary progressive MS, secondary-progressive MS and progressive-recurrent MS. Relapsing-remitting MS is the most common form of MS.

The symptoms appear in the form of relapses, which are of a variable duration and which vary from one episode to the other, according to the affected area in the CNS. After the flare-ups, symptoms subside and usually disappear completely, although there may be neurological aftereffects. In primary-progressive MS, a progressive clinical deterioration occurs, without relapses, from the onset of the illness. This type of MS is suffered by 12% of people with MS. In secondary-progressive MS, patients initially present a relapsing-remitting course, however, over time, they develop a progressive clinical deterioration without experiencing distinctive relapses. Progressive-recurrent MS, is the least common type of illness.

Two fundamental and complementary aspects exist in the treatment of MS: pharmacological and rehabilitation treatments. Over recent years, a substantial change has occurred in the approach to MS, thanks to the appearance of new drugs aimed at modifying the progression of the disease. However, these drugs would be more effective if they were complemented by a good rehabilitation program. With regards rehabilitation, a symptomatic treatment of MS is performed in order to improve the quality of life and functional independence, with the main therapeutic demands being the alterations of postural control and the performance of activities of daily living. Occupational therapy (OT) assesses the capacities and physical, psychological, sensory and social problems of the individual with MS, in order to enable the person to achieve the greatest possible level of independence in their daily living and/or to facilitate the adaptation to their disability. At times, rehabilitation treatments for patients with MS can be very lengthy and systematic, leading to patients that lose motivation and compliance. As a result, in recent years, new intervention strategies have been introduced, such as virtual reality (VR), thanks to VR motion capture technology without the need of using any device or controller. Here, patient motivation is promoted via novel approaches based on practicing functional tasks in virtual surroundings, which provide feedback to the patient concerning results, and are based on the repetition of activities of daily living (ADLs). The development of these technologies has provided rehabilitation professionals with the ability to expand the care of patients with MS as a complement to their rehabilitation program, achieving a higher treatment intensity at a sustainable cost. However, there are few studies on the effects that VR has on the manual dexterity of patients with MS.

Therefore, the objective of the present study was to analyze the effects of an OT intervention combined with VR on manual skills, compared with conventional OT approaches in people with MS.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Manual dexterity, gross dexterity and coordination
timeFrame: 2 mothns and 15 days between assessments. The "change" that it is being assessed is fine manual dexterity
measure: Hand´s functional capacity
timeFrame: 2 mothns and 15 days between assessments. The "change" that it is being assessed is hand's functional status
measure: Manipulative dexterity
timeFrame: 2 mothns and 15 days between assessments. The "change" that it is being assessed is manipulative dexterity
Secondary outcomes:
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Roberto Cano de la Cuerda
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Roberto Cano de la Cuerda, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.