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

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.

Study Overview

• Status: Completed
• Conditions: Nervous System Diseases; Rehabilitation; Telerehabilitation; Technology
• Intervention / Treatment: Other: Multimedial Rehabilitation; Other: Usual care program

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20148
    • Fondazione Don Carlo Gnocchi Onlus
  • LC
    • Lecco, LC, Italy, 23845
      • Ospedale Valduce
  • TO
    • Torino, TO, Italy, 10131
      • Presidio Sanitario S Camillo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus
• Collaborators: Centro Riabilitativo Villa Beretta; Fondazione Opera S Camillo
• Investigators: Principal Investigator: Franco Molteni, MD, Valduce Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: January 12, 2017
• First Submitted That Met QC Criteria: January 16, 2017
• First Posted (Estimate): January 19, 2017

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: FdG_HEAD_01