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Virtual Reality for Upper Limb Rehabilitation in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
University of Cagliari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Rehabilitation, Upper limbs, Virtual Reality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Laboratorio di Biomeccanica ed Ergonomia industriale - Università degli Studi di CagliariRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual reality intervention

Observational

Arm Description

Participant undergo 12 treatment sessions, during a 4-week period (3 sessions per week). Each intervention session lasts 45 minutes.

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

Outcomes

Primary Outcome Measures

Change in box and block score
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.

Secondary Outcome Measures

Change in Nine-Hole Peg score
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.

Full Information

First Posted
July 16, 2019
Last Updated
July 17, 2019
Sponsor
University of Cagliari
Collaborators
Italian Multiple Sclerosis Foundation, Fondazione Don Carlo Gnocchi Onlus, Azienda Sanitaria Locale di Cagliari
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1. Study Identification

Unique Protocol Identification Number
NCT04027491
Brief Title
Virtual Reality for Upper Limb Rehabilitation in Multiple Sclerosis
Official Title
Innovative Low-cost Solutions Based on Virtual Reality for Upper Limb Home-based Rehabilitation in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 23, 2019 (Actual)
Primary Completion Date
June 3, 2021 (Anticipated)
Study Completion Date
June 3, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cagliari
Collaborators
Italian Multiple Sclerosis Foundation, Fondazione Don Carlo Gnocchi Onlus, Azienda Sanitaria Locale di Cagliari

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: Use of commercial low-cost VR systems (e.g. Oculus Rift) Use of public domain software for the Virtual Reality package (i.e. Unity 3D) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Rehabilitation, Upper limbs, Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Interventional, randomized, controlled, cross-over study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality intervention
Arm Type
Experimental
Arm Description
Participant undergo 12 treatment sessions, during a 4-week period (3 sessions per week). Each intervention session lasts 45 minutes.
Arm Title
Observational
Arm Type
No Intervention
Arm Description
Participant undergo a 4 weeks observational period. No intervention are performed.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in box and block score
Description
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.
Time Frame
Baseline (T0), immediately after the end of the treatment (+4 weeks, T1), +8 weeks from the baseline (T2)
Secondary Outcome Measure Information:
Title
Change in Nine-Hole Peg score
Description
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.
Time Frame
Baseline (T0), immediately after the end of the treatment (+4 weeks, T1), +8 weeks from the baseline (T2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Massimiliano Pau, PhD
Phone
070/675-3264
Email
massimiliano.pau@dimcm.unica.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimiliano Pau, PhD
Organizational Affiliation
University of Cagliari
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratorio di Biomeccanica ed Ergonomia industriale - Università degli Studi di Cagliari
City
Monserrato
State/Province
Cagliari
ZIP/Postal Code
09042
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimiliano Pau, PhD
Phone
070/675-3264
Email
massimiliano.pau@dimcm.unica.it

12. IPD Sharing Statement

Learn more about this trial

Virtual Reality for Upper Limb Rehabilitation in Multiple Sclerosis

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