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

Not Applicable

Completed

• Conditions: Rehabilitation; Technology; Nervous System Diseases; Telerehabilitation
• Interventions: Other: Multimedial Rehabilitation; Other: Usual care program

• Registration Number: NCT03025126
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-16
• Study First Posted: 2017-01-19
• Primary Completion: 2017-08
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-02-16
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HEAD Rehabilitation	Multimedial Rehabilitation	rehabilitation with IT multimedial devices
Usual care program	Usual care program	usual care program

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Unilateral gross manual dexterity assessed on Box and Blocks Test (BBT)	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
Attention and concentration assessed on Attention and Concentration test	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
Static balance and fall risk assessed on Berg Balance Scale (BBS)	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
Caregiver Need assessed on Caregiver Need Assessment (CNA) questionnaire	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

Trial Locations

Locations (3)

Ospedale Valduce; 🇮🇹 Lecco, LC, Italy

Fondazione Don Carlo Gnocchi ONLUS; 🇮🇹 Milano, Italy

Presidio Sanitario S Camillo; 🇮🇹 Torino, TO, Italy