Multiple SclerosisNCT04027491
Virtual Reality for Upper Limb Rehabilitation in Multiple Sclerosis
A study testing Virtual Reality in people with Multiple Sclerosis, run by University of Cagliari at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 23 Apr 2019to 3 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Laboratorio di Biomeccanica ed Ergonomia industriale - Università degli Studi di Cagliari
Monserrato, Cagliari, 09042
Massimiliano Pau, PhD, 070/675-3264, massimiliano.pau@dimcm.unica.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Virtual Reality
- Keywords
- Rehabilitation, Upper limbs, Virtual Reality
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality intervention | Experimental | Participant undergo 12 treatment sessions, during a 4-week period (3 sessions per week).
Each intervention session lasts 45 minutes. Receives: Behavioral: Virtual Reality |
| Observational | No intervention | Participant undergo a 4 weeks observational period. No intervention are performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline (T0), immediately after the end of the treatment (+4 weeks, T1), +8 weeks from the baseline (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start23 Apr 2019
- Primary completion3 Jun 2021 (estimated)
- Study completion3 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Interventional, randomized, controlled, cross-over study
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Collaborators
- Italian Multiple Sclerosis Foundation, Fondazione Don Carlo Gnocchi ETS, Azienda Sanitaria Locale di Cagliari
- Responsible party
- Principal investigator, Massimiliano Pau, University of Cagliari
- Investigators
- Massimiliano Pau, PhD, Principal investigator, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027491
- Sponsor's protocol ID
- 102/2018/CE
- Other IDs
- 2017/R/19
- Status last verified
- Jul 2019
- First submitted
- 16 Jul 2019
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Low-cost Solutions Based on Virtual Reality for Upper Limb Home-based Rehabilitation in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04027491
- Acronym / sponsor ID
- 102/2018/CE
- Conditions
- Multiple Sclerosis
- Keywords
- Rehabilitation, Upper limbs, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Collaborators
- Italian Multiple Sclerosis Foundation, Fondazione Don Carlo Gnocchi ETS, Azienda Sanitaria Locale di Cagliari
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 3 Jun 2021 (estimated)
- Study completion
- 3 Jun 2022 (estimated)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional, randomized, controlled, cross-over study
| Arm | Type | Receives |
|---|---|---|
| Virtual reality intervention | Experimental | Behavioral: Virtual RealityParticipant undergo 12 treatment sessions, during a 4-week period (3 sessions per week). Each intervention session lasts 45 minutes. |
| Observational | No intervention | –Participant undergo a 4 weeks observational period. No intervention are performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityThe 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. | Behavioural | Virtual reality intervention |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimiliano Pau, PhD principal investigator
University of Cagliari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Multiple Sclerosis, run by University of Cagliari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Massimiliano Pau, PhD (070/675-3264, massimiliano.pau@dimcm.unica.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019.