Back to resultsSemi-inmersive Virtual Reality on Upper Limb in Multiple Sclerosis
Primary Purpose
Multiple Sclerosis, Treatment Adherence, Upper Extremity Paresis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Conventional therapy
semi-inversive tech
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
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.
Sites / Locations
- Roberto Cano de la Cuerda
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional therapy
semi-inmersive VR technology plus conventional therapy
Arm Description
Conventional Physical therapy for the upper limb
Conventional Physical therapy for the upper limb plus semi-inmersive VR technology
Outcomes
Primary Outcome Measures
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.
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
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.
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
Secondary Outcome Measures
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
Adherence
The attendance rate (%) for therapy sessions (compliance) will be registered
Full Information
NCT ID
NCT04171908
First Posted
November 12, 2019
Last Updated
June 20, 2023
Sponsor
Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT04171908
Brief Title
Semi-inmersive Virtual Reality on Upper Limb in Multiple Sclerosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
March 11, 2023 (Actual)
Study Completion Date
April 11, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Treatment Adherence, Upper Extremity Paresis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional therapy
Arm Type
Active Comparator
Arm Description
Conventional Physical therapy for the upper limb
Arm Title
semi-inmersive VR technology plus conventional therapy
Arm Type
Experimental
Arm Description
Conventional Physical therapy for the upper limb plus semi-inmersive VR technology
Intervention Type
Other
Intervention Name(s)
Conventional therapy
Intervention Description
Conventional Physical therapy for the upper limb
Intervention Type
Other
Intervention Name(s)
semi-inversive tech
Intervention Description
Conventional Physical therapy for the upper limb plus Semi-inversive tech
Primary Outcome Measure Information:
Title
Jamar
Description
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.
Time Frame
8 weeks
Title
Box and blocks
Description
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
Time Frame
8 weeks
Title
The Purdue Pegboard Test
Description
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.
Time Frame
8 weeks
Title
Nine Hole Peg Test
Description
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
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
The Client Satisfaction Questionnaire
Description
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
Time Frame
after 8 weeks of treatment
Title
Adherence
Description
The attendance rate (%) for therapy sessions (compliance) will be registered
Time Frame
after 8 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Roberto Cano de la Cuerda
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35743333
Citation
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.
Results Reference
derived
PubMed Identifier
32660604
Citation
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.
Results Reference
derived
Learn more about this trial
Semi-inmersive Virtual Reality on Upper Limb in Multiple Sclerosis
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