CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Robotic assisted interventiondevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04223180
NCT04223180N/ACompleted

Stroke Rehabilomics Study: Epigenetics and Genetics Characterization of the BDNF and SLC6A4 Genes in Patients Undergoing Robotic Rehabilitation Treatment

Fondazione Don Carlo Gnocchi Onlus·observational·Posted Jan 10, 2020·Updated Feb 23, 2021

In Brief

An observational study evaluating Robotic assisted intervention for Stroke. Completed, enrolled 50 participants across 1 site.

Detailed Summary

Stroke is associated with disability and impaired quality of life. Persistent motor impairment is common with incomplete recovery of motor function after rehabilitation, mainly in the upper limbs (UL). Robot-mediated therapy (RMT) has been proposed as a viable approach for the rehabilitation of the UL, but more rigorous studies are needed to tailor rehabilitation and to better address the treatment. Brain-derived neurotrophic factor (BDNF) and the serotonin transporter gene (SLC6A4) have been shown to play an important role in post-stroke recovery. After ischemic stroke, disruption and subsequent reorganization of functional brain connections occur both locally and far from the lesion, with the latter possibly contributing to function recovery. This project aims to assess whether epigenetic and genetic variations of BDNF and SLC6A4 can occur in stroke patients after robotic rehabilitation treatment. This study will allow to identify potential genetic and epigenetic biomarkers in post-stroke rehabilitation that could be used to predict the response to a specific rehabilitation treatment and to choose the optimal treatment for the patient (Rehabilomics).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 10, 2020
Enrollment StartJan 20, 2020
Primary CompletionJan 31, 2021
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 6.5 years ago

Interventions

Robotic assisted interventiondevice

Robotic treatment of the upper limb (30 sessions, 5 times a week) using a set of 4 robotic devices: Motore (Humanware); Amadeo, Diego, Pablo (Tyromotion). The training will include motor-cognitive exercises specifically selected to train spatial attention, vision and working memory, praxis, executive function, and speed of processing.