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

Study Overview
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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.

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

Conditions
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Rehabilitation, Technology, Telerehabilitation, Nervous System Diseases

Intervention / Treatment
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* Other: Multimedial Rehabilitation
* Other: Usual care program


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEAD Rehabilitation<br>rehabilitation with IT multimedial devices | Other: Multimedial Rehabilitation<br> <br> |
| Active Comparator: Usual care program<br>usual care program | Other: Usual care program<br>* Usual care at home program according to healthcare professional's advice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life assessed on the short-form 12-item Health Survey (SF-12) questionnaire |  | change 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static balance and fall risk assessed on Berg Balance Scale (BBS) |  | 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 | 
| 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 test |  | change 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 | 
| Caregiver Need assessed on Caregiver Need Assessment (CNA) questionnaire |  | change from baseline after 4 months and after 7 months |