Virtual Reality for Upper Limb Rehabilitation in Multiple Sclerosis

July 17, 2019 updated by: Massimiliano Pau, University of Cagliari

Innovative Low-cost Solutions Based on Virtual Reality for Upper Limb Home-based Rehabilitation in Multiple Sclerosis

This study is aimed to test the efficacy and feasibility of an immersive virtual reality (VR) rehabilitation programs to improve upper-limb motor functions in 24 patients with multiple sclerosis (pwMS), characterized by moderate to severe upper-limb motor dysfunctions. In particular, this study will evaluate the efficacy of VR as novel opportunities to increase treatment engagement and rehabilitation effects.

The effectiveness of the rehabilitation program will be assessed using both clinical tests and state-of-the art motion capture system for human movement analysis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Recent studies highlighted the high social and economic burden of rehabilitation in multiple sclerosis (MS); in fact its cost is approximately 27% of the overall expenses supported by the national health system. In particular, it has been shown that the physical rehabilitation is effective in treating functional impairments associated to gait, balance and daily life activitites. However, most rehabilitative treatments are performed at hospital or in specialized centers, and this is a factor which strongly reduces the persistence of the positive effects in the long-term.

In this context, it appears important to highlight that rehabilitative treatments are often focused on lower limbs functional impairments, while upper limbs dysfunctions seem less considered although approximately 50% of pwMS complain about issues like reduction of manual dexterity and fine motor abilities as well as movements' slowness. Moreover, significantly lower is also the number of the studies focused on upper limbs rehabilitation, if compared to those about walking or balance and also if compared with upper limbs studies in other neurologic diseases like stroke.

A support in overcoming such issues might be provided by the adoption of low-cost devices originally designed for entertainment purposes (e.g. Nintendo Wii or Microsoft Kinect) which have been shown effective in improving some aspects of disability. Nevertheless, while rehabilitation protocols which make use of such system often relies on software designed for healthy individuals, it should be essential to have available routines specifically designed for the MS needs.

On the basis of these considerations, this project intends to design, develop and test an innovative low-cost hardware/software platform for home-based upper limbs rehabilitation based on virtual reality.

In particular, the software will reproduce scenarios of actual daily living activities with increasing complexity to ensure a good degree of transferability of the training into real life.

The strength of this approach lies basically on three factors:

  1. Use of commercial low-cost VR systems (e.g. Oculus Rift)
  2. Use of public domain software for the Virtual Reality package (i.e. Unity 3D)
  3. Availability of kinematic data derived from the analysis of the hand trajectories, which allow clinicians to characterize the performance of the participants as well as his/her progresses The effectiveness of the platform will be tested in laboratory using state-of-the-art motion capture system for human movement analysis.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Cagliari
      • Monserrato, Cagliari, Italy, 09042
        • Recruiting
        • Laboratorio di Biomeccanica ed Ergonomia industriale - Università degli Studi di Cagliari
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18
  • Definite MS diagnosis, sub-type Relapsing-Remitting or Secondary Progressive
  • Clinically stable
  • No relapses at the time of the enrolment in the study
  • Able to understand the informed consent process and provide consent to participate in the study
  • 9-Hole Peg Test score > 30 seconds

Exclusion Criteria:

  • Relapses occurring over the past 3 months
  • History of seizures
  • Severe blurred vision
  • Concomitant auditory and vestibular deficits
  • Presence of other neurological, orthopaedic (non-MS related), psychiatric or cognitive impairments that would interfere with the execution of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual reality intervention

Participant undergo 12 treatment sessions, during a 4-week period (3 sessions per week).

Each intervention session lasts 45 minutes.

The selected commercial games are aimed mostly to improve upper limb functions. The games will be randomly administered during each session. Each game will be played for approximately 10 minutes, with 5 minutes break between each game session.

The intervention treatment consists of 12 sessions in 4-week period.

No Intervention: Observational
Participant undergo a 4 weeks observational period. No intervention are performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in box and block score
Time Frame: Baseline (T0), immediately after the end of the treatment (+4 weeks, T1), +8 weeks from the baseline (T2)

The Box and Block Test measures unilateral gross manual dexterity. Score consists of the number of blocks transferred from one compartment to the other compartment in 60 seconds (score each hand separately). Higher values indicate better performance.

Reference value for unaffected population is 55 blocks/min.

Baseline (T0), immediately after the end of the treatment (+4 weeks, T1), +8 weeks from the baseline (T2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Nine-Hole Peg score
Time Frame: Baseline (T0), immediately after the end of the treatment (+4 weeks, T1), +8 weeks from the baseline (T2)
The Nine-Hole Peg Test measures finger dexterity. Score consists of the time to place and remove one by one the holes on the board, as quickly as possible. Higher values indicate worse performance.
Baseline (T0), immediately after the end of the treatment (+4 weeks, T1), +8 weeks from the baseline (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Massimiliano Pau, PhD, University of Cagliari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2019

Primary Completion (Anticipated)

June 3, 2021

Study Completion (Anticipated)

June 3, 2022

Study Registration Dates

First Submitted

July 16, 2019

First Submitted That Met QC Criteria

July 17, 2019

First Posted (Actual)

July 22, 2019

Study Record Updates

Last Update Posted (Actual)

July 22, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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