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

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

Study Overview

• Status: Completed
• Conditions: Hemiparesis
• Intervention / Treatment: Device: GRAIL population

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lecco
    • Bosisio Parini, Lecco, Italy, 23842
      • IRCCS E.Medea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: IRCCS Eugenio Medea

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: rehabilitation; children; hemiparesis; virtual reality; GRAIL
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paresis
• Other Study ID Numbers: 585

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No