Clinical trial NCT03025126: Human Empowerment Aging and Disability (HEAD): New Technologies for Neurorehabilitation
Official title: Human Empowerment Aging and Disability (HEAD): New Technologies for Neurorehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Technology
Telerehabilitation
Nervous System Diseases
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Centro Riabilitativo Villa Beretta
name: Fondazione Opera S Camillo
First posted: 2017-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Health-related quality of life assessed on the short-form 12-item Health Survey (SF-12) questionnaire
timeFrame: change from baseline after 4 months and after 7 months
measure: Global cognitive state assessed on MONTREAL COGNITIVE ASSESSMENT (MOCA)
timeFrame: change from baseline after 4 months and after 7 months
measure: Endurance assessed on two-minute walking test (2MWT)
timeFrame: change from baseline after 4 months and after 7 months
measure: Positive and negative affective state assessed on Positive and Negative Affect Scale (PANAS)
timeFrame: change from baseline after 4 months and after 7 months
Secondary outcomes:
measure: Static balance and fall risk assessed on Berg Balance Scale (BBS)
timeFrame: change from baseline after 4 months and after 7 months
measure: Finger dexterity assessed on 9-Hole Peg Test (9HPT)
timeFrame: change from baseline after 4 months and after 7 months
measure: Unilateral gross manual dexterity assessed on Box and Blocks Test (BBT)
timeFrame: change from baseline after 4 months and after 7 months
measure: Walking speed assessed on 10-Meter Walking Test (10MWT)
timeFrame: change from baseline after 4 months and after 7 months
measure: Strength in upper and lower extremities assessed on Motricity Index (MI)
timeFrame: change from baseline after 4 months and after 7 months
measure: Attention and concentration assessed on Attention and Concentration test
timeFrame: change from baseline after 4 months and after 7 months
measure: Memory abilities assessed on Rivermead Behavioural Memory Test - 3 (RBMT3)
timeFrame: change from baseline after 4 months and after 7 months
measure: Caregiver Need assessed on Caregiver Need Assessment (CNA) questionnaire
timeFrame: change from baseline after 4 months and after 7 months
Other outcomes:
Locations:
city: Lecco
country: Italy
facility: Ospedale Valduce
state: LC
city: Torino
country: Italy
facility: Presidio Sanitario S Camillo
state: TO
city: Milano
country: Italy
facility: Fondazione Don Carlo Gnocchi ONLUS
Study officials:
affiliation: Valduce Hospital
name: Franco Molteni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.