NCT04027491

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2022

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

2.1 years

First QC Date

July 16, 2019

Last Update Submit

July 17, 2019

Conditions

Multiple Sclerosis

Keywords

RehabilitationUpper limbsVirtual Reality

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (1)

  • Change in Nine-Hole Peg score

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

Study Arms (2)

Virtual reality intervention

EXPERIMENTAL

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

Behavioral: Virtual Reality

Observational

NO INTERVENTION

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

Interventions

Virtual RealityBEHAVIORAL

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.

Virtual reality intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Hole Peg Test score \> 30 seconds

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Monserrato, Cagliari, 09042, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Massimiliano Pau, PhD

    University of Cagliari

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimiliano Pau, PhD

CONTACT

070/675-3264massimiliano.pau@dimcm.unica.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Interventional, randomized, controlled, cross-over study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Head of the

Study Record Dates

First Submitted

July 16, 2019

First Posted

July 22, 2019

Study Start

April 23, 2019

Primary Completion

June 3, 2021

Study Completion

June 3, 2022

Last Updated

July 22, 2019

Record last verified: 2019-07

Locations

IT(1)