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

Hemiparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04286997
• Other study ID #: 585
• Status: Completed
• Phase: N/A
• Start date: September 13, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: IRCCS Eugenio Medea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

• 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemiparesis
• Paresis

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS E.Medea	Bosisio Parini	Lecco

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Eugenio Medea

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait Analysis	Analysis of the walking pattern performed with traditional gait analysis lab and with GRAIL system	1 month
Primary	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	6 Minute Walking Test	recording of the distance run by the patient in a lapse of time of 6 minutes	1 month
Secondary	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