Human Empowerment Aging and Disability (HEAD): New Technologies for Neurorehabilitation

NCT ID: NCT03025126

Last Updated: 2018-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-12-31

Brief Summary

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Congenital or acquired neurological disorders could lead to consistent motor and cognitive disabilities. The continuity and persistency of a tailored home rehabilitation protocol after recovery is crucial to prevent disease aggravation or relapses. The integration of a web-based new technology in home rehabilitation programme can constitute a functional low cost resource by offering patients off-line (and on-line) monitoring and by proposing new motivating ways of rehabilitation through high tech tools such as serious games.

Detailed Description

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Conditions

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Rehabilitation Technology Telerehabilitation Nervous System Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HEAD Rehabilitation

rehabilitation with IT multimedial devices

Group Type EXPERIMENTAL

Multimedial Rehabilitation

Intervention Type OTHER

Usual care program

usual care program

Group Type ACTIVE_COMPARATOR

Usual care program

Intervention Type OTHER

Usual care at home program according to healthcare professional's advice

Interventions

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Multimedial Rehabilitation

Intervention Type OTHER

Usual care program

Usual care at home program according to healthcare professional's advice

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age range 18-85
* Parkinson Disease (PD - mild to moderate) in stable treatment for at least 3 months
* Multiple Sclerosis (MS) without relapses in the last 3 months (EDSS ≤ 6)
* post stroke ( ≥ 6 months after the acute event)

Exclusion Criteria

* Mini Mental State Examination \< 20
* limited range of motion
* severe pain
* severe deficit of visual acuity or auditory perception or communication and severe dysmetry
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Riabilitativo Villa Beretta

UNKNOWN

Sponsor Role collaborator

Fondazione Opera S Camillo

UNKNOWN

Sponsor Role collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Franco Molteni, MD

Role: PRINCIPAL_INVESTIGATOR

Valduce Hospital

Locations

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Ospedale Valduce

Lecco, LC, Italy

Site Status

Presidio Sanitario S Camillo

Torino, TO, Italy

Site Status

Fondazione Don Carlo Gnocchi ONLUS

Milan, , Italy

Site Status

Countries

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Italy

References

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Jonsdottir J, Baglio F, Gindri P, Isernia S, Castiglioni C, Gramigna C, Palumbo G, Pagliari C, Di Tella S, Perini G, Bowman T, Salza M, Molteni F. Virtual Reality for Motor and Cognitive Rehabilitation From Clinic to Home: A Pilot Feasibility and Efficacy Study for Persons With Chronic Stroke. Front Neurol. 2021 Apr 7;12:601131. doi: 10.3389/fneur.2021.601131. eCollection 2021.

Reference Type DERIVED
PMID: 33897579 (View on PubMed)

Other Identifiers

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FdG_HEAD_01

Identifier Type: -

Identifier Source: org_study_id

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