HemiparesisNCT04286997
VARA (Virtual and Augmented Reality Applications in Rehabilitation): Motor Rehabilitation Protocol With GRAIL for Patients Affected by Hemiparesis
A study testing GRAIL population in people with Hemiparesis, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial summary
The main goal of the study is to verify the efficacy of the GRAIL system in respect to the walking pattern improvement in a population of hemiparetic subjects. In particular, the specific goals will be: increase in walking symmetry and a better distribution among the time of stance and swing. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Hemiparesis
- What is being tested?
- GRAIL population
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 13 Sep 2018to 31 Dec 2020
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- hemiparetic patients as a consequence of acquired brain injury
Who cannot join
- excessive muscular spasticity or contractures.
- recent (under 6 months) lower limbs surgery
- cognitive or emotional/relational obstacles to the therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VARA: Motor Rehabilitation Protocol With GRAIL for Patients Affected by Hemiparesis
The main goal of the study is to verify the efficacy of the GRAIL system in respect to the walking pattern improvement in a population of hemiparetic subjects.
In particular, the specific goals will be:
- increase in walking symmetry and a better distribution among the time of stance and swing.
- Kinematics and Kinetics correction, with incentive of more corrected activation timing.
- Recruitment of the muscles most involved by the paresis, with the help of visual feedback.
- walking speed increase (but with the priority of the walking pattern)
- increase in the resistance
- Stregthening of the support reaction
- Conditions
- Hemiparesis
- Being tested
- GRAIL population
- Keywords
- GRAIL, children, rehabilitation, virtual reality, hemiparesis
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRAIL populationDevice
each subjects included in the intervention group will receive 20 GRAIL sessions, aimed to the walking pattern improvement, associated with 20 traditional physiotherapy sessions, aimed to the stabilization of the trained competences
| Study group | Role | What they receive |
|---|---|---|
| GRAIL population | Experimental | patients are treated with 20 sessions of GRAIL rehabilitation, associated to 20 traditional physiotherapy sessions (1+1 a day, during a period of 30 days) Receives: Device: GRAIL population |
| traditional population | Active comparator | subjects are treated with 40 sessions of traditional physiotherapy (2 a day, during a period of 30 days) Receives: Device: GRAIL population |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Analysis
Analysis of the walking pattern performed with traditional gait analysis lab and with GRAIL system
Measured: 1 month
Gross Motor Functional Movement
Assessment of the kinetic function, divided into 5 dimensions, range from 0 to 88, 0 meaning worse scores and 88 healthy subjects.
Measured: 1 month
Secondary outcomes (2)
6 Minute Walking Test
recording of the distance run by the patient in a lapse of time of 6 minutes
Measured: 1 month
Functional Assessment Questionaire
Questionaire Filled in by the patients or by the parents, on the perception of the walking ability, range from 1 (subjects unable to step) to 10 (healthy subjects)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start13 Sep 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiparesisStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286997
- Sponsor's protocol ID
- 585
- Status last verified
- Mar 2021
- First submitted
- 25 Feb 2020
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VARA: Motor Rehabilitation Protocol With GRAIL for Patients Affected by Hemiparesis
- ClinicalTrials.gov ID
- NCT04286997
- Acronym / sponsor ID
- 585
- Conditions
- Hemiparesis
- Keywords
- GRAIL, children, rehabilitation, virtual reality, hemiparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 27 Feb 2020 (actual)
- 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.
The main goal of the study is to verify the efficacy of the GRAIL system in respect to the walking pattern improvement in a population of hemiparetic subjects.
In particular, the specific goals will be:
- increase in walking symmetry and a better distribution among the time of stance and swing.
- Kinematics and Kinetics correction, with incentive of more corrected activation timing.
- Recruitment of the muscles most involved by the paresis, with the help of visual feedback.
- walking speed increase (but with the priority of the walking pattern)
- increase in the resistance
- Stregthening of the support reaction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GRAIL population | Experimental | Device: GRAIL populationpatients are treated with 20 sessions of GRAIL rehabilitation, associated to 20 traditional physiotherapy sessions (1+1 a day, during a period of 30 days) |
| traditional population | Active comparator | Device: GRAIL populationsubjects are treated with 40 sessions of traditional physiotherapy (2 a day, during a period of 30 days) |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- hemiparetic patients as a consequence of acquired brain injury
Key exclusion criteria (3 listed)
- excessive muscular spasticity or contractures.
- recent (under 6 months) lower limbs surgery
- cognitive or emotional/relational obstacles to the therapy
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 |
|---|---|---|
| GRAIL populationeach subjects included in the intervention group will receive 20 GRAIL sessions, aimed to the walking pattern improvement, associated with 20 traditional physiotherapy sessions, aimed to the stabilization of the trained competences | Device | GRAIL population, traditional population |
Primary outcome
Gait Analysis
Time frame: 1 month
Analysis of the walking pattern performed with traditional gait analysis lab and with GRAIL system
Gross Motor Functional Movement
Time frame: 1 month
Assessment of the kinetic function, divided into 5 dimensions, range from 0 to 88, 0 meaning worse scores and 88 healthy subjects.
2 secondary outcomes
6 Minute Walking Test
Time frame: 1 month
Functional Assessment Questionaire
Time frame: 1 month
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 12 Mar 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GRAIL population in people with Hemiparesis, run by IRCCS Eugenio Medea at 1 site 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 1 inclusion and 3 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 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Gait Analysis (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2021.