Back to resultsVARA (Virtual and Augmented Reality Applications in Rehabilitation): Motor Rehabilitation Protocol With GRAIL for Patients Affected by Hemiparesis
Primary Purpose
Hemiparesis
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
GRAIL population
Sponsored by
About this trial
This is an interventional treatment trial for Hemiparesis focused on measuring GRAIL, children, rehabilitation, virtual reality, hemiparesis
Eligibility Criteria
Inclusion Criteria:
- hemiparetic patients as a consequence of acquired brain injury
Exclusion Criteria:
- excessive muscular spasticity or contractures.
- recent (under 6 months) lower limbs surgery
- cognitive or emotional/relational obstacles to the therapy
Sites / Locations
- IRCCS E.Medea
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GRAIL population
traditional population
Arm Description
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)
subjects are treated with 40 sessions of traditional physiotherapy (2 a day, during a period of 30 days)
Outcomes
Primary Outcome Measures
Gait Analysis
Analysis of the walking pattern performed with traditional gait analysis lab and with GRAIL system
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.
Secondary Outcome Measures
6 Minute Walking Test
recording of the distance run by the patient in a lapse of time of 6 minutes
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04286997
Brief Title
VARA (Virtual and Augmented Reality Applications in Rehabilitation): Motor Rehabilitation Protocol With GRAIL for Patients Affected by Hemiparesis
Official Title
VARA: Motor Rehabilitation Protocol With GRAIL for Patients Affected by Hemiparesis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 13, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Eugenio Medea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis
Keywords
GRAIL, children, rehabilitation, virtual reality, hemiparesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GRAIL population
Arm Type
Experimental
Arm Description
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)
Arm Title
traditional population
Arm Type
Active Comparator
Arm Description
subjects are treated with 40 sessions of traditional physiotherapy (2 a day, during a period of 30 days)
Intervention Type
Device
Intervention Name(s)
GRAIL population
Intervention Description
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
Primary Outcome Measure Information:
Title
Gait Analysis
Description
Analysis of the walking pattern performed with traditional gait analysis lab and with GRAIL system
Time Frame
1 month
Title
Gross Motor Functional Movement
Description
Assessment of the kinetic function, divided into 5 dimensions, range from 0 to 88, 0 meaning worse scores and 88 healthy subjects.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
6 Minute Walking Test
Description
recording of the distance run by the patient in a lapse of time of 6 minutes
Time Frame
1 month
Title
Functional Assessment Questionaire
Description
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)
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
hemiparetic patients as a consequence of acquired brain injury
Exclusion Criteria:
excessive muscular spasticity or contractures.
recent (under 6 months) lower limbs surgery
cognitive or emotional/relational obstacles to the therapy
Facility Information:
Facility Name
IRCCS E.Medea
City
Bosisio Parini
State/Province
Lecco
ZIP/Postal Code
23842
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
VARA (Virtual and Augmented Reality Applications in Rehabilitation): Motor Rehabilitation Protocol With GRAIL for Patients Affected by Hemiparesis
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