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

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.