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Virtual Reality for Upper Limb 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Sclerosis | Behavioral: Virtual Reality | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 24 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Intervention Model Description: | Interventional, randomized, controlled, cross-over study |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Innovative Low-cost Solutions Based on Virtual Reality for Upper Limb Home-based Rehabilitation in Multiple Sclerosis |
| Actual Study Start Date : | April 23, 2019 |
| Estimated Primary Completion Date : | June 3, 2021 |
| Estimated Study Completion Date : | June 3, 2022 |
| 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. |
Behavioral: Virtual Reality
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.
|
- 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.
- 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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
| Contact: Massimiliano Pau, PhD | 070/675-3264 | massimiliano.pau@dimcm.unica.it |
| Italy | |
| Laboratorio di Biomeccanica ed Ergonomia industriale - Università degli Studi di Cagliari | Recruiting |
| Monserrato, Cagliari, Italy, 09042 | |
| Contact: Massimiliano Pau, PhD 070/675-3264 massimiliano.pau@dimcm.unica.it | |
| Principal Investigator: | Massimiliano Pau, PhD | University of Cagliari |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 16, 2019 | ||||
| First Posted Date ICMJE | July 22, 2019 | ||||
| Last Update Posted Date | July 22, 2019 | ||||
| Actual Study Start Date ICMJE | April 23, 2019 | ||||
| Estimated Primary Completion Date | June 3, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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.
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Virtual Reality for Upper Limb Rehabilitation in Multiple Sclerosis | ||||
| Official Title ICMJE | Innovative Low-cost Solutions Based on Virtual Reality for Upper Limb Home-based Rehabilitation in Multiple Sclerosis | ||||
| 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. |
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| 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:
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: Interventional, randomized, controlled, cross-over study Masking: None (Open Label)Primary Purpose: Treatment |
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| Condition ICMJE | Multiple Sclerosis | ||||
| Intervention ICMJE | Behavioral: Virtual Reality
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. |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
24 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | June 3, 2022 | ||||
| Estimated Primary Completion Date | June 3, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Italy | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04027491 | ||||
| Other Study ID Numbers ICMJE | 102/2018/CE 2017/R/19 ( Other Grant/Funding Number: FISM ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Massimiliano Pau, University of Cagliari | ||||
| Study Sponsor ICMJE | University of Cagliari | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | University of Cagliari | ||||
| Verification Date | July 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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