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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03025126
Acronym
HEAD
Enrollment
100
Registered
2017-01-19
Start date
2016-03-31
Completion date
2017-12-31
Last updated
2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nervous System Diseases, Rehabilitation, Technology, Telerehabilitation

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.

Interventions

OTHERMultimedial Rehabilitation

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

Sponsors

Centro Riabilitativo Villa Beretta
CollaboratorUNKNOWN
Fondazione Opera S Camillo
CollaboratorUNKNOWN
Fondazione Don Carlo Gnocchi Onlus
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Health-related quality of life assessed on the short-form 12-item Health Survey (SF-12) questionnairechange from baseline after 4 months and after 7 months
Global cognitive state assessed on MONTREAL COGNITIVE ASSESSMENT (MOCA)change from baseline after 4 months and after 7 months
Endurance assessed on two-minute walking test (2MWT)change from baseline after 4 months and after 7 months
Positive and negative affective state assessed on Positive and Negative Affect Scale (PANAS)change from baseline after 4 months and after 7 months

Secondary

MeasureTime frame
Strength in upper and lower extremities assessed on Motricity Index (MI)change from baseline after 4 months and after 7 months
Attention and concentration assessed on Attention and Concentration testchange from baseline after 4 months and after 7 months
Static balance and fall risk assessed on Berg Balance Scale (BBS)change from baseline after 4 months and after 7 months
Caregiver Need assessed on Caregiver Need Assessment (CNA) questionnairechange from baseline after 4 months and after 7 months
Memory abilities assessed on Rivermead Behavioural Memory Test - 3 (RBMT3)change from baseline after 4 months and after 7 months
Finger dexterity assessed on 9-Hole Peg Test (9HPT)change from baseline after 4 months and after 7 months
Unilateral gross manual dexterity assessed on Box and Blocks Test (BBT)change from baseline after 4 months and after 7 months
Walking speed assessed on 10-Meter Walking Test (10MWT)change from baseline after 4 months and after 7 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026