NCT03486704

Telerehabilitation in Mild Cognitive Impairment

The Italian Network of Telerehabilitation: Evaluation of Telerehabilitation System in Mild Cognitive Impairment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The main aim of the study is to evaluate the efficacy of the Virtual Reality Rehabilitation System (VRRS) compared to usual care treatment for patients with Mild Cognitive Impairment (MCI). Moreover, we will assess the possibility to prolong the beneficial effects of the treatment with an innovative telerehabilitation system. In the second phase of the present study we aim to evaluate the short and long term effects induced by the treatment of active (anodal) transcranial Direct Current Stimulation (tDCS) applied to the left dorsolateral prefrontal cortex combined with VRRS compared to placebo tDCS stimulation combined with VRRS. The effects of the intervention on outcome variables will be assessed using a randomized controlled trial design with five groups. The investigators will assess the effects of VRRS system and of the implementation of the at-home treatment on the quality of life, cognitive and functional abilities.

Conditions

• Mild Cognitive Impairment

Interventions

Type	Name	Description
BEHAVIORAL	Face to Face VRRS and telerehabilitation	Face to Face cognitive training using VRRS plus telerehabilitation. Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week. Cognitive training will initially be tailored to the patient's baseline characteristics. The exercise program will be charged by therapist on the patient's computer before the beginning of the at-home treatment. Each patient's performed session will be reviewed by the therapist. The group will receive a kit home-based (a tablet home, access to a daily individualized cognitive training program).
BEHAVIORAL	Usual rehabilitation program	The usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program.
BEHAVIORAL	FTF VRRS plus unstructured CS	Face to Face cognitive training using VRRS plus at-home unstructured cognitive stimulation. Participants will receive 12 sessions of an individualized Face to Face (FTF) cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based unstructured cognitive stimulation (CS), three sessions for week.
BEHAVIORAL	Face to Face VRRS plus active tDCS and telerehabilitation	Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week. Face to Face VRRS cognitive training will initially be tailored to the patient's baseline characteristics. The exercise program will be charged by therapist on the patient's computer before the beginning of the at-home treatment. Each patient's performed session will be reviewed by the therapist.The group will receive a kit home-based (a tablet home, access to a daily individualized cognitive training program).
BEHAVIORAL	Face to Face VRRS plus placebo tDCS and telerehabilitation	Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with placebo tDCS applied to the dorsolateral prefrontal cortex of the left hemisphere over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week. Face to Face VRRS cognitive training will initially be tailored to the patient's baseline characteristics. The exercise program will be charged by therapist on the patient's computer before the beginning of the at-home treatment. Each patient's performed session will be reviewed by the therapist.The group will receive a kit home-based (a tablet home, access to a daily individualized cognitive training program).

Timeline

• Start date: 2018-04-09
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2018-04-03
• Last updated: 2024-08-14

Locations

1 site across 1 country: Italy