Clinical trial NCT04032431: Upper Limb Telerehabilitation With Virtual Reality in Multiple Sclerosis
Official title: The Effect of a Telerehabilitation Virtual Reality Intervention on Functional Upper Limb Activities in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Rehabilitation
Virtual Reality
Upper limb
Neurorehabilitation
Lead sponsor: University of Cagliari
Sponsor class: OTHER
Collaborators: name: Azienda Sanitaria Locale di Cagliari
name: Tel Aviv University
First posted: 2019-07-25
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, assessor blinded, parallel group pilot RCT that will be conducted at:

1. The Sardinian Center for Diagnosis and Treatment of Multiple Sclerosis, Cagliari, Italy.
2. The Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel.

Participants will be randomly assigned to one of the two intervention groups:

1. Telerehab VR training;
2. Conventional therapy

The two interventions will be comparable in length (8-weeks), frequency (twice weekly) and session duration (50-60 min).

Pre-intervention tests (T0) characterizing groups and obtaining baseline values of primary and secondary outcome measures will be performed one week±3 days prior to the intervention program.

Within one week after completion of the intervention, post-intervention tests will be performed (T1). The same tests will be repeated after 1-month of follow-up (T2). During the follow-up period (T1-T2), patients will be instructed to continue their regular activities.
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effectiveness of a home-based telerehabilitation program specifically designed for upper limbs, based on Virtual Reality (VR) in individuals affected by Multiple Sclerosis.

Detailed description: Approximately 60% of people with multiple sclerosis (pwMS) suffer from upper limb dysfunction. The primary goal of this study 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.

Methodology. Twenty-four pwMS will be recruited to participate in the study which will be conducted at two established MS Centers: (1) The Sardinian Center for Diagnosis and Treatment of Multiple Sclerosis, Binaghi Hospital, Cagliari, Italy; (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 or prone position, indicative of the standard care in multiple sclerosis (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.

Potential scientific contribution. 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 and will then be disseminated to neurologists and other medical providers.

Mode of cooperation and added value. The Italian group will be responsible for designing and implementing three new VR scenarios relating to functional activities of the upper limb. The new VR scenarios will be planned in conjunction with the Israeli group who will also play an active role in the quality assessment procedures of the developed elements. Both groups will participate equally in the pilot RCT. Roles include: recruitment and guidance of patients and therapists, implementing the telerehab VR system in the patient's home, assessment of outcome measures, data collection, analysis and interpretation of data and dissemination of the findings. An additional role of the Israeli team will be to prepare a user manual detailing how to use the system and providing clinical guidelines/recommendations for both the therapist and patient.

Eligibility criteria: Inclusion Criteria:

1. diagnosis of MS according to the revised McDonald Criteria 2017;
2. aged 25-60 years old;
3. an Expanded Disability Status Scale score ≥6;
4. an ability to understand and execute simple instructions;
5. a cut-off score of \>0.5 pegs/s(=18s) on the NHPT (selected due to its high discriminative and predictive ability in distinguishing ADL independence in pwMS).

Exclusion Criteria:

1. orthopedic and other neurological disorders affecting upper limb movements (e.g., epileptic seizures);
2. contra-indication to physical activity (e.g., heart failure, severe osteoporosis);
3. moderate or severe cognitive impairments as indicated by the Mini-Mental State Examination score \<21;
4. pregnancy (self-reported);
5. severe uncorrected visual deficits;
6. MS clinical relapse or treatment with corticosteroid therapy within 90 days prior to enrollment;
7. started or stopped a disease-modifying therapy for MS within 90 days prior to enrollment;
8. patients who received a course of physical or occupational therapy (home, outpatient or inpatient) within the past 30 days;
9. other treatments that could influence the effects of the interventions

Primary outcomes:
measure: Change in Nine Hole Peg Test (9HPT)
timeFrame: Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline)
Secondary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline), 1 month follow-up (T2, +12 weeks from baseline)
measure: Manual Ability Measure-36 (MAM-36)
timeFrame: Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline), 1 month follow-up (T2, +12 weeks from baseline)
measure: Value of "Impression of change" parameter
timeFrame: Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline), 1 month follow-up (T2, +12 weeks from baseline)
Other outcomes:
Locations:
city: Tel HaShomer
country: Israel
facility: The Multiple Sclerosis Center, Sheba Medical Center
city: Monserrato
country: Italy
facility: Laboratorio di Biomeccanica ed Ergonomia industriale - Università degli Studi di Cagliari
state: Cagliari
Study officials:
affiliation: University of Cagliari
name: Eleonora Cocco, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kalron A, Achiron A, Pau M, Cocco E. 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. Trials. 2020 Aug 12;21(1):713. doi: 10.1186/s13063-020-04650-2.