Upper Limb Telerehabilitation With Virtual Reality in Multiple Sclerosis

NCT04032431 | Unknown

• 1 other identifier: Italy-Israel-2019
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 2

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.

Conditions

Multiple Sclerosis

Keywords

Rehabilitation; Virtual Reality; Upper limb; Neurorehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Nine Hole Peg Test (9HPT)

  The NHPT was selected based on the widespread adoption and extensive data available. Furthermore, the NHPT is recommended as a gold standard for measuring manual dexterity in pwMS.31 The NHPT has excellent psychometric properties regarding reliability, discriminant, concurrent and ecological validity, can detect progression over time, is sensitive to treatment and as such, is recommended for inclusion in clinical trials. Briefly explained, the NHPT requires participants to repeatedly place nine pegs into nine holes, one at a time, as quickly as possible and then remove them from the holes. The total time needed to complete the task is then recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand.

  Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline)

Secondary Outcomes (3)

• Action Research Arm Test (ARAT)

  Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline), 1 month follow-up (T2, +12 weeks from baseline)

• Manual Ability Measure-36 (MAM-36)

  Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline), 1 month follow-up (T2, +12 weeks from baseline)

• Value of "Impression of change" parameter

  Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline), 1 month follow-up (T2, +12 weeks from baseline)

Study Arms (2)

Telerehab VR intervention

EXPERIMENTAL

The telerehab VR intervention consists of a custom-made software running on a computer connected with a commercial VR device (i.e. Oculus Rift). PwMS will be requested to reproduce several ADLs from the three main areas of self-care, dressing and meal preparation. The user can physically see his/her hands within the virtual scenario and, during the exercise, the hand coordinates are continuously recorded. Thus, data on 3D trajectory, speed, accuracy on target placement and movement smoothness, will be accessible. They will be stored in the PC and also be remotely sent to the clinical center for further analysis/processing. Both target position and task complexity will define the exercise difficulty, which can be modified automatically, on the basis of the previous performance or manually modified by the user

Behavioral: Telerehab VR intervention

Conventional therapy

ACTIVE COMPARATOR

Conventional therapy will focus on task-related upper-limb treatments while in a sitting or prone position, representing the standard care in MS. Several manual techniques, therapy tools and objects of ADL will be allowed during treatment. No restrictions will be placed on the material used (ie, ADL, reaching and grasping material). Use of additional electrical or mechanical therapy devices (ie, support arm systems, splints) will be avoided. The interventions will be conducted on a one-on-one basis in the physiotherapy or occupational therapy department of each participating center. Training and therapy content will be tailored to each participant's preferences, the agreed movement aims and the motor function level of each MS patient.

Behavioral: Telerehab VR intervention

Interventions

Telerehab VR intervention BEHAVIORAL

Training with VR system using software specifically designed to reproduce activities of daily living

Conventional therapy; Telerehab VR intervention

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosis of MS according to the revised McDonald Criteria 2017;
• aged 25-60 years old;
• an Expanded Disability Status Scale score ≥6;
• an ability to understand and execute simple instructions;
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Cagliari: lead
• Azienda Sanitaria Locale di Cagliari: collaborator
• Tel Aviv University: collaborator

Study Sites (2)

The Multiple Sclerosis Center, Sheba Medical Center

Tel Litwinsky, Israel

Location

Laboratorio di Biomeccanica ed Ergonomia industriale - Università degli Studi di Cagliari

Monserrato, Cagliari, 09042, Italy

Location

Related Publications (1)

• 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.

  PMID: 32787896 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eleonora Cocco, PhD

  University of Cagliari

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimiliano Pau, PhD

CONTACT

+390706753264; massimiliano.pau@dimcm.unica.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Physical therapists and bioengineers in charge of outcome assessment are not involved in study design
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Head of the

Model Details: 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.

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 25, 2019
• Study Start: December 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); IL (1)