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Completed

NCT Number: NCT04286997

VARA (Virtual and Augmented Reality Applications in Rehabilitation): 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

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Key information

Conditions

Hemiparesis Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS E.Medea

Bosisio Parini, Lecco, 23842, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GRAIL population

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

Primary outcomes

  1. Gait Analysis

    Time frame: 1 month

    Analysis of the walking pattern performed with traditional gait analysis lab and with GRAIL system

  2. Gross Motor Functional Movement

    Time frame: 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 outcomes

  1. 6 Minute Walking Test

    Time frame: 1 month

    recording of the distance run by the patient in a lapse of time of 6 minutes

  2. Functional Assessment Questionaire

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

IRCCS Eugenio Medea

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 27, 2020
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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