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The effect of a telerehabilitation virtual reality intervention on functional upper limb activities in people with multiple sclerosis: a study protocol for the TEAMS pilot randomized controlled trial.

ABSTRACT: BACKGROUND:Approximately 60% of people with multiple sclerosis (PwMS) suffer from upper limb dysfunction. Our primary goal is to implement a single-blind, randomized control trial (RCT) designed to compare the effectiveness of an 8-week home-based telerehab virtual reality (VR) program with conventional therapy in PwMS with manual dexterity difficulties. Secondary aims include (a) evaluating the impact of the programs on quality of life after the intervention and a follow-up 1?month later and (b) evaluating the impact of the programs on adherence and satisfaction. METHODS:Twenty-four PwMS will be recruited to the study which will be conducted at two established MS centers: (1) The Regional Center for Diagnosis and Treatment of Multiple Sclerosis, Binaghi Hospital, Cagliari, Italy, and (2) The Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel. Participants will complete a total of three assessments focusing on upper limb functions. Both groups will receive 16 training sessions focusing on functional upper limb activities. The home-based telerehab VR intervention will comprise a custom-made software program running on a private computer or laptop. PwMS will perform several activities of daily living (ADL) functions associated with self-care, dressing, and meal preparation. Conventional therapy will focus on task-related upper-limb treatments while in a sitting position, indicative of the standard care in MS. Following 8 weeks of training, participants will complete a further outcome assessment. The same tests will be conducted 1?month (as a follow-up) after completion of the intervention. DISCUSSION:The outcomes of this study have tremendous potential to improve the quality of evidence and informed decisions of functional upper limb activities in PwMS. If comparable results are found between the treatments in improving upper limb outcomes, this would suggest that PwMS can choose the program that best meets their personal needs, e.g., financial concerns, transportation, or accessibility issues. Secondly, this information can be used by healthcare providers and medical professionals in developing upper limb exercise programs that will most likely succeed in PwMS. TRIAL REGISTRATION:ClinicalTrials.gov NCT04032431 . Registered on 19 July 2019.

SUBMITTER: Kalron A

PROVIDER: S-EPMC7425044 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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The effect of a telerehabilitation virtual reality intervention on functional upper limb activities in people with multiple sclerosis: a study protocol for the TEAMS pilot randomized controlled trial.

Kalron Alon A Achiron Anat A Pau Massimiliano M Cocco Eleonora E

Trials 20200812 1

<h4>Background</h4>Approximately 60% of people with multiple sclerosis (PwMS) suffer from upper limb dysfunction. Our primary goal is to implement a single-blind, randomized control trial (RCT) designed to compare the effectiveness of an 8-week home-based telerehab virtual reality (VR) program with conventional therapy in PwMS with manual dexterity difficulties. Secondary aims include (a) evaluating the impact of the programs on quality of life after the intervention and a follow-up 1 month late ...[more]

PMID: 32787896

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Project description:BackgroundTechnology-mediated neurorehabilitation is suggested to enhance training intensity and therefore functional gains. Here, we used a novel virtual reality (VR) system for task-specific upper extremity training after stroke. The system offers interactive exercises integrating motor priming techniques and embodied visuomotor feedback. In this pilot study, we examined (i) rehabilitation dose and training intensity, (ii) functional improvements, and (iii) safety and tolerance when exposed to intensive VR rehabilitation.MethodsTen outpatient stroke survivors with chronic (>6 months) upper extremity paresis participated in a ten-session VR-based upper limb rehabilitation program (2 sessions/week).ResultsAll participants completed all sessions of the treatment. In total, they received a median of 403 min of upper limb therapy, with 290 min of effective training. Within that time, participants performed a median of 4713 goal-directed movements. Importantly, training intensity increased progressively across sessions from 13.2 to 17.3 movements per minute. Clinical measures show that despite being in the chronic phase, where recovery potential is thought to be limited, participants showed a median improvement rate of 5.3% in motor function (Fugl-Meyer Assessment for Upper Extremity; FMA-UE) post intervention compared to baseline, and of 15.4% at one-month follow-up. For three of them, this improvement was clinically significant. A significant improvement in shoulder active range of motion (AROM) was also observed at follow-up. Participants reported very low levels of pain, stress and fatigue following each session of training, indicating that the intensive VR intervention was well tolerated. No severe adverse events were reported. All participants expressed their interest in continuing the intervention at the hospital or even at home, suggesting high levels of adherence and motivation for the provided intervention.ConclusionsThis pilot study showed how a dedicated VR system could deliver high rehabilitation doses and, importantly, intensive training in chronic stroke survivors. FMA-UE and AROM results suggest that task-specific VR training may be beneficial for further functional recovery both in the chronic stage of stroke. Longitudinal studies with higher doses and sample sizes are required to confirm the therapy effectiveness.Trial registrationThis trial was retrospectively registered at ClinicalTrials.gov database (registration number NCT03094650 ) on 14 March 2017.

Project description:BackgroundMultiple sclerosis (MS) is a common nontraumatic, neurological, disabling disease that often presents with upper limb dysfunction. Exercise training has resulted in improvement for patients; however, there can be a lack of compliance due to access because of location and lack of MS experts. Virtual reality (VR) is a promising technology that can offer exercise therapy/rehabilitation at a distance. This type of remote training can be motivational and effective for patients with MS and can improve range of motion and muscle strength for those with upper limb dysfunction.ObjectiveThe aim of this study is to evaluate the safety and feasibility of the XRHealth software and the Oculus Rift Station for patients with MS with upper limb motor dysfunction.MethodsA single-center, prospective, feasibility study was conducted with patients with MS who had upper limb motor dysfunction. Patients participated in a single 45-minute digital environment session with VR and completed a questionnaire about the quality of the training and fatigability. The clinician also completed a questionnaire to evaluate the suitability and safety of the training.ResultsOverall, 30 patients were enrolled between the ages of 20 and 81 years. Patients reported that the training sessions within the digital environment were helpful, challenging, fun, and simple to understand, and that they would be willing to repeat the sessions again. The physical therapist that oversaw the patients reported that the training was suitable for 87% (n=26) of the patients. Anticipated adverse events were fatigue, temporary dizziness, and temporary nausea. The operator complications included that the cable of the head-mounted display interrupted the training (n=2, 7%) and fatigue that caused cessation of the VR training session (n=2, 7%). No serious adverse events were reported.ConclusionsThese preliminary results demonstrated that the use of the XRHealth software and Oculus Rift Station platform is feasible, safe, and engaging for patients, and has the potential to improve the functionality of the upper limbs in patients with MS. This study provides support for future studies of implementing a series of training sessions with virtual reality in a home-based environment.

Project description:BACKGROUND:Remote virtual rehabilitation aroused growing interest in the last decades, and its role has gained importance following the recent spread of COVID19 pandemic. The advantages of virtual reality (VR), augmented reality (AR), gamification, and telerehabilitation have been demonstrated in several medical fields. In this review, we searched the literature for studies using these technologies for orthopedic rehabilitation and analyzed studies' quality, type and field of rehabilitation, patients' characteristics, and outcomes to describe the state of the art of VR, AR, gamification, and telerehabilitation for orthopedic rehabilitation. METHODS:A comprehensive search on PubMed, Medline, Cochrane, CINAHL, and Embase databases was conducted. This review was performed according to PRISMA guidelines. Studies published between 2015 and 2020 about remote virtual rehabilitations for orthopedic patients were selected. The Methodological Index for Non-Randomized Studies (MINORS) and Cochrane Risk-of-Bias assessment tool were used for quality assessment. RESULTS:24 studies (9 randomized controlled trials (RCTs) and 15 non-randomized studies) and 2472 patients were included. Studies mainly concern telerehabilitation (56%), and to a lesser extent VR (28%), AR (28%), and gamification (16%). Remote virtual technologies were used following knee and hip arthroplasty. The majority of included patients were between 40 and 60 years old and had a university degree. Remote virtual rehabilitation was not inferior to face-to-face therapy, and physical improvements were demonstrated by increased clinical scores. Orthopedic virtual remote rehabilitation decreased costs related to transports, hospitalizations, and readmissions. CONCLUSION:The heterogeneity of included studies prevented a meta-analysis of their results. Age and social context influence adaptability to technology, and this can modify compliance to treatment and outcomes. A good relationship between patient and physiotherapist is essential for treatment compliance and new technologies are useful to maintain clinical interactions remotely. Remote virtual technologies allow the delivery of high-quality care at reduced costs. This is a necessity given the growing demand for orthopedic rehabilitation and increasing costs related to it. Future studies need to develop specific and objective methods to evaluate the clinical quality of new technologies and definitively demonstrate advantages of VR, AR, gamification, and telerehabilitation compared to face-to face orthopedic rehabilitation.

Project description:Background:Kinematic analysis using virtual reality (VR) environment provides quantitative assessment of upper limb movements. This technique has rarely been used in evaluating motor function in stroke despite its availability in stroke rehabilitation. Objective:To determine the discriminative validity of VR-based kinematics during target-to-target pointing task in individuals with mild or moderate arm impairment following stroke and in healthy controls. Methods:Sixty-seven participants with moderate (32-57 points) or mild (58-65 points) stroke impairment as assessed with Fugl-Meyer Assessment for Upper Extremity were included from the Stroke Arm Longitudinal study at the University of Gothenburg-SALGOT cohort of non-selected individuals within the first year of stroke. The stroke groups and 43 healthy controls performed the target-to-target pointing task, where 32 circular targets appear one after the other and disappear when pointed at by the haptic handheld stylus in a three-dimensional VR environment. The kinematic parameters captured by the stylus included movement time, velocities, and smoothness of movement. Results:The movement time, mean velocity, and peak velocity were discriminative between groups with moderate and mild stroke impairment and healthy controls. The movement time was longer and mean and peak velocity were lower for individuals with stroke. The number of velocity peaks, representing smoothness, was also discriminative and significantly higher in both stroke groups (mild, moderate) compared to controls. Movement trajectories in stroke more frequently showed clustering (spider's web) close to the target indicating deficits in movement precision. Conclusion:The target-to-target pointing task can provide valuable and specific information about sensorimotor impairment of the upper limb following stroke that might not be captured using traditional clinical scale. Trial registration details:The trial was registered with register number NCT01115348 at clinicaltrials.gov, on May 4, 2010. URL: https://clinicaltrials.gov/ct2/show/NCT01115348.

Dataset Information

The effect of a telerehabilitation virtual reality intervention on functional upper limb activities in people with multiple sclerosis: a study protocol for the TEAMS pilot randomized controlled trial.

Publications

The effect of a telerehabilitation virtual reality intervention on functional upper limb activities in people with multiple sclerosis: a study protocol for the TEAMS pilot randomized controlled trial.

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