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

NCT ID: NCT04286997

Last Updated: 2021-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-13

Study Completion Date

2020-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Hemiparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

GRAIL population

Intervention Type DEVICE

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

traditional population

subjects are treated with 40 sessions of traditional physiotherapy (2 a day, during a period of 30 days)

Group Type ACTIVE_COMPARATOR

GRAIL population

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Eugenio Medea

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS E.Medea

Bosisio Parini, Lecco, Italy

Site Status

Countries

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Italy

Other Identifiers

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585

Identifier Type: -

Identifier Source: org_study_id

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