Effects of Robot-assistED Rehabilitation Versus OccupatIonal Therapy on the Functional Recovery of the Upper Limb in PatiEnts with Chronic STroke: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device, Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The functional recovery of the upper limb represents a critical element in post-stroke rehabilitation; hemiplegic/hemiparetic patients who achieve optimal recovery are a minority, and incomplete recovery has relevant consequences both on functioning and on quality of life of those who survive a stroke. The project aims to assess the effects on the functional recovery, with manual dexterity as the primary outcome, of a treatment protocol using an innovative tool (Gloreha Sinfonia) that enables assisted execution of three-dimensional tasks combined with Serious Games for cognitive stimulation, targeting the functional recovery of the upper limb in patients with stroke outcomes at least 6 months after the acute event (chronic phase). Patients with residual dysfunction of the upper limb, at least 6 months after the stroke, will be randomly assigned to the Robotic Rehabilitation group (ROBOT), the Occupational Therapy group (OT), focused on the use of the upper limb in functional tasks (task-oriented training), or the control group (CT - prescription of a home exercise program). Patients in the ROBOT and OT groups will undergo a total treatment period of 5 weeks, with 3 sessions per week lasting 1 hour, for a total of 15 sessions/hours of treatment. Patients assigned to the CT group will undergo an initial functional assessment required for defining the exercise program. All patients will be evaluated at baseline (T0), at a 5-week interval (T1), and 6 months after the end of treatment (T2). Outcome indicators include measures of manual dexterity/upper limb performance, anxiety/depression, cognitive abilities, and patient-perceived outcomes. The analysis of Surface Plasmon Resonance imaging (SPRi) of serum exosome content, detected at T0, T1, and T2, will be correlated with variations in functional measures to verify the hypothesis that induction of neuroplasticity underlies any observed changes. Short- and medium-term effects on functional, psychological outcomes, as well as indicators of neuroinflammation and neural regeneration from serum analysis using innovative SPRi, will be compared among the 3 groups.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• First ischemic or hemorrhagic stroke occurring at least 6 months prior.

• Persistent motor deficit in the affected upper limb (Motricity Index between 18 and 77).

• Willingness to participate in the study, with the provision of informed consent.

Locations
Other Locations
Italy
Fondazione Don Carlo Gnocchi Onlus
RECRUITING
Florence
Contact Information
Primary
Francesca Cecchi, MD
francesca.cecchi@unifi.it
3388627184
Backup
Chiara Castagnoli, PT
ccastagnoli@dongnocchi.it
3333738921
Time Frame
Start Date: 2023-09-19
Estimated Completion Date: 2025-09-19
Participants
Target number of participants: 72
Treatments
Experimental: Group A - Robotic therapy
Group A will undergo rehabilitative treatment using Gloreha Sinfonia hand robot, administered by a physical therapist experienced in robotic rehabilitation. The treatment will involve a set of progressively challenging exercises over the course of five weeks (3 sessions per week, each lasting 1 hour). The delivery of the treatment will be conducted in a face-to-face mode.
Experimental: Group B - Occupational Therapy
Group B will attend small group occupational therapy treatment (occupational therapist/patient ratio: 1:4). Subjects will attend a rehabilitative intervention lasting a total of 5 weeks, with three sessions per week, each lasting one hour, for a total of 15 hours of treatment.
Active_comparator: Group C - Control Group
Group C (control group) will receive advice from an experienced physiotherapist for a personalized exercise program to be independently carried out at their own residence. The program will focus on the upper limb and will be based on the assessment conducted at baseline.
Related Therapeutic Areas
Sponsors
Collaborators: Fondazione Don Carlo Gnocchi Onlus
Leads: University of Florence

This content was sourced from clinicaltrials.gov