Telerehabilitation in Multiple Sclerosis
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| ClinicalTrials.gov Identifier: NCT03444454 |
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Recruitment Status :
Recruiting
First Posted : February 23, 2018
Last Update Posted : February 12, 2021
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The main aim of the study is to evaluate the efficacy of the Virtual Reality Rehabilitation System (VRRS, Khymeia) compared to usual care treatment for patients with MS at home.
The effects of the intervention on outcome variables will be assessed using a randomized controlled trial design with a comparison group receiving usual care training. The investigators will assess the effect of VRRS system on the quality of life, motor, and cognitive abilities. (Phase I) In the second phase of the present study we aim to evaluate the effects induced by the treatment of active (anodal) transcranial Direct Current Stimulation (tDCS) applied to the left dorsolateral prefrontal cortex (lDLPFC) combined with VRRS compared to placebo tDCS stimulation combined with VRRS. The effects of the intervention patient-relevant outcomes will be assessed using a randomized controlled trial design with four groups. The investigators will assess the effect of VRRS system on patient-relevant outcomes motor, cognitive and participation. (Phase II)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Sclerosis | Behavioral: VRRS Khymeia Behavioral: Usual care program Behavioral: VRRS Khymeia plus active tDCS Behavioral: VRRS Khymeia plus placebo tDCS | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 136 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | The Italian Network of Telerehabilitation: Evaluation of Telerehabilitation System for Continuum of Care in Multiple Sclerosis |
| Actual Study Start Date : | February 26, 2018 |
| Actual Primary Completion Date : | December 31, 2018 |
| Estimated Study Completion Date : | January 31, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: VRRS Khymeia
The group will receive a kit home-based (a tablet home, an exercise equipment, access to a daily individualized training program). The exercise program will be remotely charged by therapist on the patient's computer. Each patient's performed session will be reviewed remotely by the therapist. |
Behavioral: VRRS Khymeia
Participants will receive an individualized exercise program set up by the therapist. The intervention applied to the experimental group will consist of 30 sessions of Khymeia VRRS training distributed in five sessions for week, each lasting 45 minutes. Each session is constructed by alternating physical with cognitive activities. The sessions will initially be tailored to the patient's baseline characteristics. Remotely, the therapist will then adjust the participant's exercise program as appropriate, by changing exercises, level of difficulty or number of repetitions. |
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Active Comparator: Usual care program
The usual care group will have written, home-based exercise program, provided to them at an initial face-to-face assessment.
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Behavioral: Usual care program
The usual care group will have written, home-based exercise program, provided to them at an initial face-to-face assessment. |
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Experimental: VRRS Khymeia plus active tDCS
The group will receive 5 sessions each lasting 45 minutes of an individualized home-based VRRS training combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 1 week, followed by 5 weeks of home-based VRRS training
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Behavioral: VRRS Khymeia plus active tDCS
Participants will receive 5 sessions each lasting 45 minutes of an individualized home-based VRRS training combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 1 week, followed by 5 weeks of home-based VRRS training. The sessions of VRRS will initially be tailored to the patient's baseline characteristics. Remotely, the therapist will then adjust the participant's exercise program as appropriate, by changing exercises, level of difficulty or number of repetitions. |
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Active Comparator: VRRS Khymeia plus placebo tDCS
The group will receive 5 sessions of an individualized home-based VRRS training combined with placebo tDCS applied to the left dorsolateral prefrontal cortex over 1 week, followed by 5 weeks of home-based VRRS training
|
Behavioral: VRRS Khymeia plus placebo tDCS
Participants will receive 5 sessions each lasting 45 minutes of an individualized home-based VRRS training combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 1 week, followed by 5 weeks of home-based VRRS training. The sessions of VRRS will initially be tailored to the patient's baseline characteristics. Remotely, the therapist will then adjust the participant's exercise program as appropriate, by changing exercises, level of difficulty or number of repetitions. |
- Change in measure of quality of life [ Time Frame: Baseline up to 6 weeks and 6 months ]
Quality of life will be measured by 54-item Multiple Sclerosis Quality of Life (MSQOL-54) questionnaire
There is no single overall score for the MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores. In addition, there are 12 subscales: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. There are also two single-item measures: satisfaction with sexual function and change in health.
Administration forms and scoring instructions can be downloaded (https://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/MSQOL54_995.pdf ).
Higher values represent a better outcome
- Change in balance [ Time Frame: Baseline up to 6 weeks and 6 months ]Mini-Balance Evalutation System (mini-BES) Test
- Change in gait [ Time Frame: Baseline up to 6 weeks and 6 months ]12-item Multiple Sclerosis Walking Scale
- Change gross manual dexterity [ Time Frame: Baseline up to 6 weeks and 6 months ]Box and Block Test
- Change in global cognitive status [ Time Frame: Baseline up to 6 weeks and 6 months ]Montreal Cognitive Assessment (MoCA) test
- Change cognitive status [ Time Frame: Baseline up to 6 weeks and 6 months ]Symbol Digit Modalities Test (Form Brief Repeatable Battery of Neuropsychological Tests )
- Change in fatigue [ Time Frame: Baseline up to 6 weeks and 6 months ]
Fatigue Severity Scale
A questionnaire with 9 items (questions)
Grading of each FSS item ranges from 1 to 7, where 1 indicates strong disagreement and 7 strong agreement, and the final score represents the mean value of the 9 items
Higher values represent a worse outcome
- Change in Emotional Traits [ Time Frame: Baseline up to 6 weeks and 6 months ]
The Regulatory Emotional Self-Efficacy (RESE) scale
The RESE scale assesses self-efficacy in expressing positive emotions and self-efficacy in managing negative emotions.
With this scale, participants rate (ranging from 1 [not well at all] to 5 [very well]) their capability to manage their emotional life. RESE scale consists of 12 items and are calculated 3 scores: 1) self-efficacy in expressing positive emotions (POS) score; 2)self-efficacy in managing negative emotions (NEG) score; 3)self-efficacy in managing despondency/distress (DES) score
Higher values within each score represent a better outcome
- Change in Behavioral (depression) [ Time Frame: Baseline up to 6 weeks and 6 months ]Beck Depression Inventory
- Change in Behavioral (anxiety) [ Time Frame: Baseline up to 6 weeks and 6 months ]State-trait anxiety inventory
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 25 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Confirmed diagnosis of Multiple Sclerosis (RR and SP) based on McDonald criteria
- Education ≥ 8 ages
- Italian mother language
- Right-handedness
- Use of corticosteroids for three months prior to the study, having and no acute exacerbations of symptoms within three months of the study.
Exclusion Criteria:
- Existence of visual acuity and acoustic perception problems, to prevent performance of VRRS activities
- Relapses next to the time of enrolment (3 months)
- EDSS > 6.5.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444454
| Contact: Francesca Baglio, MD | 0240308069 | fbaglio@dongnocchi.it | |
| Contact: Laura Mendozzi, MD | 0240308206 | lmendozzi@dongnocchi.it |
| Italy | |
| Irccs Fondazione Don Carlo Gnocchi | Recruiting |
| Milano, MI, Italy, 20148 | |
| Contact: Laura Mendozzi, MD 0240308069 lmendozzi@dongnocchi.it | |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Francesca Baglio, MD, researcher, Fondazione Don Carlo Gnocchi Onlus |
| ClinicalTrials.gov Identifier: | NCT03444454 |
| Other Study ID Numbers: |
FdG_VRRS_MS_01 |
| First Posted: | February 23, 2018 Key Record Dates |
| Last Update Posted: | February 12, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Telerehabilitation Virtual reality Quality of life transcranial Direct Current Stimulation |
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Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |