Telerehabilitation in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

The Italian Network of Telerehabilitation: Evaluation of Telerehabilitation System for Continuum of Care in Multiple Sclerosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03444454
• Other study ID #: FdG_VRRS_MS_01
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 136
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.
• Usual care program
The usual care group will have written, home-based exercise program, provided to them at an initial face-to-face assessment.
• 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.
• 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.

Locations

Country	Name	City	State
Italy	Irccs Fondazione Don Carlo Gnocchi	Milano	MI

Sponsors (6)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus	IRCCS Centro Neurolesi Bonino-Pulejo, Messina (IT), IRCCS Fondazione Istituto Neurologico Casimiro Mondino, Pavia (IT), IRCCS San Camillo, Venezia, Italy, IRCCS San Raffaele Roma, Istituti Clinici Scientifici Maugeri SpA

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Di Tella S, Pagliari C, Blasi V, Mendozzi L, Rovaris M, Baglio F. Integrated telerehabilitation approach in multiple sclerosis: A systematic review and meta-analysis. J Telemed Telecare. 2020 Aug-Sep;26(7-8):385-399. doi: 10.1177/1357633X19850381. Epub 2019 May 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in measure of quality of life	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	Baseline up to 6 weeks and 6 months
Secondary	Change in balance	Mini-Balance Evalutation System (mini-BES) Test	Baseline up to 6 weeks and 6 months
Secondary	Change in gait	12-item Multiple Sclerosis Walking Scale	Baseline up to 6 weeks and 6 months
Secondary	Change gross manual dexterity	Box and Block Test	Baseline up to 6 weeks and 6 months
Secondary	Change in global cognitive status	Montreal Cognitive Assessment (MoCA) test	Baseline up to 6 weeks and 6 months
Secondary	Change cognitive status	Symbol Digit Modalities Test (Form Brief Repeatable Battery of Neuropsychological Tests )	Baseline up to 6 weeks and 6 months
Secondary	Change in fatigue	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	Baseline up to 6 weeks and 6 months
Secondary	Change in Emotional Traits	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	Baseline up to 6 weeks and 6 months
Secondary	Change in Behavioral (depression)	Beck Depression Inventory	Baseline up to 6 weeks and 6 months
Secondary	Change in Behavioral (anxiety)	State-trait anxiety inventory	Baseline up to 6 weeks and 6 months