NCT03444454

Telerehabilitation in Multiple Sclerosis

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Fondazione Don Carlo Gnocchi Onlus · Academic / Other
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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.
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.
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.
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.

Timeline

• Start date: 2018-02-26
• Primary completion: 2018-12-31
• Completion: 2024-06-30
• First posted: 2018-02-23
• Last updated: 2024-05-03

Locations

1 site across 1 country: Italy