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

Sponsor

IRCCS Eugenio Medea (Other)

Overall Status

Completed

CT.gov ID

NCT04286997

Collaborator

(none)

Enrollment

Location

Arms

27.6

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Hemiparesis	Device: GRAIL population	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 13, 2018

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Gait Analysis [1 month]
Analysis of the walking pattern performed with traditional gait analysis lab and with GRAIL system
Gross Motor Functional Movement [1 month]
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 [1 month]
recording of the distance run by the patient in a lapse of time of 6 minutes
Functional Assessment Questionaire [1 month]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS E.Medea	Bosisio Parini	Lecco	Italy	23842

Sponsors and Collaborators

IRCCS Eugenio Medea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

IRCCS Eugenio Medea

ClinicalTrials.gov Identifier:

NCT04286997

Other Study ID Numbers:

First Posted:

Feb 27, 2020

Last Update Posted:

Mar 12, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by IRCCS Eugenio Medea

Additional relevant MeSH terms:

Paresis

Study Results

No Results Posted as of Mar 12, 2021