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CompletedNCT03025126HEADUpdated Feb 19, 2018

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

An interventional study of Multimedial Rehabilitation and Usual care program in Rehabilitation, Technology and Telerehabilitation, sponsored by Fondazione Don Carlo Gnocchi Onlus. Completed at 3 sites in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-02-19.

Sponsored by Fondazione Don Carlo Gnocchi Onlus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
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Study 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.

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Conditions studied

  • Rehabilitation
  • Technology
  • Telerehabilitation
  • Nervous System Diseases
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In context

Nervous System Diseases

974 studies on the registry are indexed under Nervous System Diseases; 252 are open to participants now.

This study's enrollment of 100 is above the median of 48 across 623 interventional studies indexed under Nervous System Diseases.

Browse Nervous System Diseases studies →

Lead sponsor

Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    HEAD Rehabilitation

    rehabilitation with IT multimedial devices

    Other: Multimedial Rehabilitation

  • Active comparator
    Usual care program

    usual care program

    Other: Usual care program

Interventions

  • OtherMultimedial Rehabilitation
  • OtherUsual care program

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

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What researchers measure

Primary outcomes

  1. Health-related quality of life assessed on the short-form 12-item Health Survey (SF-12) questionnaire

    Time frame: change from baseline after 4 months and after 7 months

  2. Global cognitive state assessed on MONTREAL COGNITIVE ASSESSMENT (MOCA)

    Time frame: change from baseline after 4 months and after 7 months

  3. Endurance assessed on two-minute walking test (2MWT)

    Time frame: change from baseline after 4 months and after 7 months

  4. Positive and negative affective state assessed on Positive and Negative Affect Scale (PANAS)

    Time frame: change from baseline after 4 months and after 7 months

Secondary outcomes

  1. Static balance and fall risk assessed on Berg Balance Scale (BBS)

    Time frame: change from baseline after 4 months and after 7 months

  2. Finger dexterity assessed on 9-Hole Peg Test (9HPT)

    Time frame: change from baseline after 4 months and after 7 months

  3. Unilateral gross manual dexterity assessed on Box and Blocks Test (BBT)

    Time frame: change from baseline after 4 months and after 7 months

  4. Walking speed assessed on 10-Meter Walking Test (10MWT)

    Time frame: change from baseline after 4 months and after 7 months

  5. Strength in upper and lower extremities assessed on Motricity Index (MI)

    Time frame: change from baseline after 4 months and after 7 months

  6. Attention and concentration assessed on Attention and Concentration test

    Time frame: change from baseline after 4 months and after 7 months

  7. Memory abilities assessed on Rivermead Behavioural Memory Test - 3 (RBMT3)

    Time frame: change from baseline after 4 months and after 7 months

  8. Caregiver Need assessed on Caregiver Need Assessment (CNA) questionnaire

    Time frame: change from baseline after 4 months and after 7 months

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Study locations

3 sites
  • Ospedale Valduce
    Lecco, LC 23845, Italy
  • Presidio Sanitario S Camillo
    Torino, TO 10131, Italy
  • Fondazione Don Carlo Gnocchi ONLUS
    Milano, 20148, Italy
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References and documents

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. PubMed 33897579 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03025126
Lead sponsor
Fondazione Don Carlo Gnocchi Onlus
Collaborators
Centro Riabilitativo Villa Beretta, Fondazione Opera S Camillo
Responsible party
Sponsor
First posted
Jan 19, 2017
Start date
Mar 2016
Primary completion
Aug 2017
Completion
Dec 2017
Last update
Feb 19, 2018

Study contacts

Franco Molteni, MD
principal investigator · Valduce Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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