Efficacy of Robotic Rehabilitation for Neuro Recovery of the Upper Limb in Subacute Stroke Survivors: An International Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This multicenter international randomized controlled trial (RCT) evaluates the effectiveness of the Gloreha Sinfonia® robotic exoskeleton for upper limb rehabilitation in individuals with subacute post-stroke paresis. The study aims to determine whether robotic-assisted therapy improves voluntary motor control and coordination more effectively than conventional rehabilitation, as measured by the Fugl-Meyer Assessment (FMA) for the upper limb (motor component). Participants will be randomly assigned to one of two groups: * Experimental Group (EG): Robotic-assisted upper limb rehabilitation combined with conventional therapy. * Control Group (CG): Conventional therapy alone including upper limb rehabilitation. Clinical assessments will be conducted at baseline (T1), post-treatment (T2), and at a 3-month follow-up (T3) using remotely administered scales. Secondary objectives include evaluating improvements in muscle strength, range of motion, eye-hand coordination, manual dexterity, and functional independence. The study will also assess prognostic factors influencing response to robotic therapy, patient satisfaction, and potential adverse events.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Both sexes

• Age 18-90 years

• Paresis of the upper limb following a recent cerebrovascular event (subacute ischemic or hemorrhagic stroke)

• Moderate to mild muscle weakness in the thumb opponens, common finger flexors, and wrist flexors, assessed with complete joint movement in absence of gravity, Medical Research Council Scale (MRC) ≥ 2

• Time from acute event \<90 days

• Ability to understand and sign the study informed consent

• Ability to perform study procedures.

Locations
United States
Pennsylvania
Jefferson Moss-Magee Rehabilitation, Department of PMR
NOT_YET_RECRUITING
Elkins Park
Other Locations
Italy
ASST Papa Giovanni XXIII
NOT_YET_RECRUITING
Bergamo
University of Catanzaro Magna Graecia
NOT_YET_RECRUITING
Catanzaro
Valduce Hospital, Villa Beretta Rehabilitation Center
NOT_YET_RECRUITING
Costa Masnaga
Department of Rehabilitative Medicine, AUSL Piacenza
NOT_YET_RECRUITING
Fiorenzuola D'arda
IRCCS Fondazione Don Gnocchi
ACTIVE_NOT_RECRUITING
Florence
Riuniti Hospital, Neurorehabilitation, Spinal Cord Rehab. and Functional Recovery Section
NOT_YET_RECRUITING
Foggia
IRCCS Centro Neurolesi Bonino-Pulejo, Innovation Technology Laboratory
NOT_YET_RECRUITING
Messina
Passignano Hospital, Department of Specialized Medicine, Usl Umbria 1
NOT_YET_RECRUITING
Passignano Sul Trasimeno
European Society of Physical and Rehabilitation Medicine, SISC in New Technologies and Robotics in Rehabilitation
NOT_YET_RECRUITING
Rome
Fondazione Policlinico Universitario Campus Bio-Medico di Roma, UOC di Medicina Fisica e Riabilitativa-CESA
NOT_YET_RECRUITING
Rome
IRCCS San Raffaele Roma
RECRUITING
Rome
San Vito Hospital, Rehabilitation Unit
NOT_YET_RECRUITING
San Vito Sullo Ionio
Russian Federation
Medical Centre for Rehabilitation Treatment Consilium
NOT_YET_RECRUITING
Moscow
Spain
Centro Lescer, Occupational Therapy and Physical Therapy Department
NOT_YET_RECRUITING
Madrid
Thailand
Chiang Mai University, Department of Occupational Therapy, Faculty of Associated Medical Sciences
NOT_YET_RECRUITING
Chiang Mai
Contact Information
Primary
Sanaz Pournajaf, DPT, PhD
sanaz.pournajfa@sanraffaele.it
+39 0652252405
Backup
Carrie Louise Thouant, OT, MSc
carrielouise.thouant@sanraffaele.it
+39 0652252338
Time Frame
Start Date: 2025-02-06
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 130
Treatments
Experimental: Experimental Group (EG)
Participants assigned to Experimental Group (EG) will follow 18+/-3sessions (from a minimum of 3 times to a maximum of 5 times/week) of robotic-assisted treatment for upper limb rehabilitation using the Gloreha Sinfonia (R-Touch Pro; BTL Robotics, USA) robotic device in addition to the standard rehabilitation program.
Active_comparator: Control Group (CG)
Participants assigned to Control Group (CG) will follow 18+/-3 sessions (from a minimum of 3 times to a maximum of 5 times/week) of conventional tratment for upper limb rehabilitation in addition to the standard rehabilitation program.
Related Therapeutic Areas
Sponsors
Leads: IRCCS San Raffaele Roma

This content was sourced from clinicaltrials.gov