Virtual Reality and Manual Dexterity in in Patients With Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03186612
• Date of registration: 09/06/2017
• Prospective Registration: No
• Primary sponsor: Universidad Rey Juan Carlos
• Public title: Virtual Reality and Manual Dexterity in in Patients With Multiple Sclerosis
• Scientific 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
• Date of first enrolment: March 2, 2016
• Target sample size: 26
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03186612
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Spain

Contacts

• Name: Roberto Cano de la Cuerda, PhD
• Affiliation: Universidad Rey Juan Carlos

• Name: Roberto Cano de la Cuerda, PhD

• Name: Roberto Cano de la Cuerda, PhD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dexterity

Physical Activity

Upper Limb

Virtual Reality

Multiple Sclerosis

Intervention(s)

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

Primary Outcome(s)

Manual dexterity, gross dexterity and coordination [Time Frame: 2 mothns and 15 days between assessments. The "change" that it is being assessed is fine manual dexterity]

Manipulative dexterity [Time Frame: 2 mothns and 15 days between assessments. The "change" that it is being assessed is manipulative dexterity]

Hand´s functional capacity [Time Frame: 2 mothns and 15 days between assessments. The "change" that it is being assessed is hand's functional status]

Secondary ID(s)

UniversidadRJC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors