VARA (Virtual and Augmented Reality Applications in Rehabilitation): Motor Rehabilitation Protocol With GRAIL for Patients Affected by Hemiparesis
VARA: Motor Rehabilitation Protocol With GRAIL for Patients Affected by Hemiparesis
1 other identifier
interventional
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 13, 2018
CompletedFirst Submitted
Initial submission to the registry
February 25, 2020
CompletedFirst Posted
Study publicly available on registry
February 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMarch 12, 2021
March 1, 2021
2.3 years
February 25, 2020
March 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Gait Analysis
Analysis of the walking pattern performed with traditional gait analysis lab and with GRAIL system
1 month
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 Outcomes (2)
6 Minute Walking Test
1 month
Functional Assessment Questionaire
1 month
Study Arms (2)
GRAIL population
EXPERIMENTALpatients are treated with 20 sessions of GRAIL rehabilitation, associated to 20 traditional physiotherapy sessions (1+1 a day, during a period of 30 days)
traditional population
ACTIVE COMPARATORsubjects are treated with 40 sessions of traditional physiotherapy (2 a day, during a period of 30 days)
Interventions
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
Eligibility Criteria
You may qualify if:
- hemiparetic patients as a consequence of acquired brain injury
You may not qualify if:
- excessive muscular spasticity or contractures.
- recent (under 6 months) lower limbs surgery
- cognitive or emotional/relational obstacles to the therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS E.Medea
Bosisio Parini, Lecco, 23842, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2020
First Posted
February 27, 2020
Study Start
September 13, 2018
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
March 12, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share