RehabilitationHEADNCT03025126
Human Empowerment Aging and Disability (HEAD): New Technologies for Neurorehabilitation
A study testing Multimedial Rehabilitation in people with Rehabilitation and Technology, run by Fondazione Don Carlo Gnocchi ETS at 3 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rehabilitation, Technology, Telerehabilitation
- What is being tested?
- Multimedial Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesItaly
- Study dates
- Mar 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Mini Mental State Examination < 20
- limited range of motion
- severe pain
- severe deficit of visual acuity or auditory perception or communication and severe dysmetry
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Ospedale Valduce
Lecco, LC, 23845
Fondazione Don Carlo Gnocchi ONLUS
Milan, 20148
Presidio Sanitario S Camillo
Torino, TO, 10131
About this study
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.
- Being tested
- Multimedial Rehabilitation, Usual care program
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimedial RehabilitationOther
Usual care programOther
Usual care at home program according to healthcare professional's advice
| Study group | Role | What they receive |
|---|---|---|
| HEAD Rehabilitation | Experimental | rehabilitation with IT multimedial devices Receives: Other: Multimedial Rehabilitation |
| Usual care program | Active comparator | usual care program Receives: Other: Usual care program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life assessed on the short-form 12-item Health Survey (SF-12) questionnaire
Measured: change from baseline after 4 months and after 7 months
Global cognitive state assessed on MONTREAL COGNITIVE ASSESSMENT (MOCA)
Measured: change from baseline after 4 months and after 7 months
Endurance assessed on two-minute walking test (2MWT)
Measured: change from baseline after 4 months and after 7 months
Positive and negative affective state assessed on Positive and Negative Affect Scale (PANAS)
Measured: change from baseline after 4 months and after 7 months
Secondary outcomes (8)
Static balance and fall risk assessed on Berg Balance Scale (BBS)
Measured: change from baseline after 4 months and after 7 months
Finger dexterity assessed on 9-Hole Peg Test (9HPT)
Measured: change from baseline after 4 months and after 7 months
Unilateral gross manual dexterity assessed on Box and Blocks Test (BBT)
Measured: change from baseline after 4 months and after 7 months
Walking speed assessed on 10-Meter Walking Test (10MWT)
Measured: change from baseline after 4 months and after 7 months
Strength in upper and lower extremities assessed on Motricity Index (MI)
Measured: change from baseline after 4 months and after 7 months
Attention and concentration assessed on Attention and Concentration test
Measured: change from baseline after 4 months and after 7 months
Memory abilities assessed on Rivermead Behavioural Memory Test - 3 (RBMT3)
Measured: change from baseline after 4 months and after 7 months
Caregiver Need assessed on Caregiver Need Assessment (CNA) questionnaire
Measured: change from baseline after 4 months and after 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startMar 2016
- Primary completionAug 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Villa Beretta Rehabilitation Center, Fondazione Opera S Camillo
- Responsible party
- Sponsor
- Investigators
- Franco Molteni, MD, Principal investigator, Valduce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025126
- Sponsor's protocol ID
- FdG_HEAD_01
- Acronym
- HEAD
- Status last verified
- Jan 2018
- First submitted
- 12 Jan 2017
- Last updated
- 19 Feb 2018
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Empowerment Aging and Disability (HEAD): New Technologies for Neurorehabilitation
- ClinicalTrials.gov ID
- NCT03025126
- Acronym / sponsor ID
- HEAD / FdG_HEAD_01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Villa Beretta Rehabilitation Center, Fondazione Opera S Camillo
- Study start
- Mar 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEAD Rehabilitation | Experimental | Other: Multimedial Rehabilitationrehabilitation with IT multimedial devices |
| Usual care program | Active comparator | Other: Usual care programusual care program |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- Mini Mental State Examination < 20
- limited range of motion
- severe pain
- severe deficit of visual acuity or auditory perception or communication and severe dysmetry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimedial Rehabilitation | Other | HEAD Rehabilitation |
| Usual care programUsual care at home program according to healthcare professional's advice | Other | Usual care program |
Primary outcome
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
Global cognitive state assessed on MONTREAL COGNITIVE ASSESSMENT (MOCA)
Time frame: change from baseline after 4 months and after 7 months
Endurance assessed on two-minute walking test (2MWT)
Time frame: change from baseline after 4 months and after 7 months
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
8 secondary outcomes
Static balance and fall risk assessed on Berg Balance Scale (BBS)
Time frame: change from baseline after 4 months and after 7 months
Finger dexterity assessed on 9-Hole Peg Test (9HPT)
Time frame: change from baseline after 4 months and after 7 months
Unilateral gross manual dexterity assessed on Box and Blocks Test (BBT)
Time frame: change from baseline after 4 months and after 7 months
Walking speed assessed on 10-Meter Walking Test (10MWT)
Time frame: change from baseline after 4 months and after 7 months
Strength in upper and lower extremities assessed on Motricity Index (MI)
Time frame: change from baseline after 4 months and after 7 months
Attention and concentration assessed on Attention and Concentration test
Time frame: change from baseline after 4 months and after 7 months
Memory abilities assessed on Rivermead Behavioural Memory Test - 3 (RBMT3)
Time frame: change from baseline after 4 months and after 7 months
Caregiver Need assessed on Caregiver Need Assessment (CNA) questionnaire
Time frame: change from baseline after 4 months and after 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Derived from this study: PubMed 33897579Jonsdottir 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franco Molteni, MD principal investigator
Valduce Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimedial Rehabilitation in people with Rehabilitation and Technology, run by Fondazione Don Carlo Gnocchi ETS at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03025126, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.