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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04286997
Other study ID # 585
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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