VARA (Virtual and Augmented Reality Applications in Rehabilitation): Motor Rehabilitation Protocol With GRAIL for Patients Affected by Hemiparesis

Study Overview
=================
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

Official Title
-----------------
VARA: Motor Rehabilitation Protocol With GRAIL for Patients Affected by Hemiparesis

Conditions
-----------------
Hemiparesis

Intervention / Treatment
-----------------
* Device: GRAIL population


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GRAIL population<br>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) | Device: GRAIL population<br>* 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<br>|
| Active Comparator: traditional population<br>subjects are treated with 40 sessions of traditional physiotherapy (2 a day, during a period of 30 days) | Device: GRAIL population<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Analysis | Analysis of the walking pattern performed with traditional gait analysis lab and with GRAIL system | 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. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Minute Walking Test | recording of the distance run by the patient in a lapse of time of 6 minutes | 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) | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GRAIL, children, rehabilitation, virtual reality, hemiparesis