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

Rehabilitation Clinical Trial

— HEAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03025126
• Other study ID #: FdG_HEAD_01
• Status: Completed
• Phase: N/A
• First received: January 12, 2017
• Last updated: February 16, 2018
• Start date: March 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Nervous System Diseases
• Rehabilitation
• Technology
• Telerehabilitation

Intervention

Other:
• Multimedial Rehabilitation

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

Locations

Country	Name	City	State
Italy	Ospedale Valduce	Lecco	LC
Italy	Fondazione Don Carlo Gnocchi ONLUS	Milano
Italy	Presidio Sanitario S Camillo	Torino	TO

Sponsors (3)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus	Centro Riabilitativo Villa Beretta, Fondazione Opera S Camillo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Global cognitive state assessed on MONTREAL COGNITIVE ASSESSMENT (MOCA)		change from baseline after 4 months and after 7 months
Primary	Endurance assessed on two-minute walking test (2MWT)		change from baseline after 4 months and after 7 months
Primary	Positive and negative affective state assessed on Positive and Negative Affect Scale (PANAS)		change from baseline after 4 months and after 7 months
Secondary	Static balance and fall risk assessed on Berg Balance Scale (BBS)		change from baseline after 4 months and after 7 months
Secondary	Finger dexterity assessed on 9-Hole Peg Test (9HPT)		change from baseline after 4 months and after 7 months
Secondary	Unilateral gross manual dexterity assessed on Box and Blocks Test (BBT)		change from baseline after 4 months and after 7 months
Secondary	Walking speed assessed on 10-Meter Walking Test (10MWT)		change from baseline after 4 months and after 7 months
Secondary	Strength in upper and lower extremities assessed on Motricity Index (MI)		change from baseline after 4 months and after 7 months
Secondary	Attention and concentration assessed on Attention and Concentration test		change from baseline after 4 months and after 7 months
Secondary	Memory abilities assessed on Rivermead Behavioural Memory Test - 3 (RBMT3)		change from baseline after 4 months and after 7 months
Secondary	Caregiver Need assessed on Caregiver Need Assessment (CNA) questionnaire		change from baseline after 4 months and after 7 months