130 Participants Needed

Robotic Rehabilitation for Stroke

(GLORIA Trial)

Recruiting at 19 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have received a botulinum toxin injection in the affected upper limb within the last 60 days or plan to during the study, you would not be eligible to participate.

How does the Gloreha Sinfonia® treatment differ from other stroke rehabilitation treatments?

The Gloreha Sinfonia® treatment is unique because it uses a robotic glove to assist with hand rehabilitation, focusing on improving motor function and reducing spasticity (muscle stiffness) in stroke patients. This approach is different from traditional therapies as it provides both active-assisted and passive robotic treatments, enhancing muscle blood flow and oxygen supply, which are not typically addressed by standard rehabilitation methods.12345

What data supports the effectiveness of the treatment Gloreha Sinfonia® for stroke rehabilitation?

Research shows that robotic therapy can improve motor function in stroke patients, with benefits lasting beyond the typical recovery period. Studies on similar robotic devices have demonstrated that patients receiving robot-assisted training alongside traditional therapy achieve better motor function than those without robotic assistance.678910

Who Is on the Research Team?

SP

Sanaz Pournajaf, DPT, PhD

Principal Investigator

IRCCS San Raffaele Roma

Are You a Good Fit for This Trial?

This trial is for individuals who have had a stroke recently and are experiencing weakness or paralysis in their arms. They should be stable enough to participate in rehabilitation therapy but haven't fully recovered their arm functions.

Inclusion Criteria

It has been less than 90 days since my acute health event.
Ability to understand and sign the study informed consent
I can follow the study's required procedures.
See 3 more

Exclusion Criteria

Presence of other overlapping neurological disorders
Severe cognitive (MMSE ≤ 17) and/or language impairment compromising exercise comprehension
Inability to adhere to the exercise program due to low compliance
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either robotic-assisted upper limb rehabilitation combined with conventional therapy or conventional therapy alone for 18±3 sessions over approximately 5 weeks.

5 weeks
3-5 visits per week

Follow-up

Participants are monitored for safety and effectiveness after treatment through clinical assessments conducted at a 3-month follow-up.

3 months
1 visit (in-person or phone interview)

What Are the Treatments Tested in This Trial?

Interventions

  • Gloreha Sinfonia®
Trial Overview The study compares two approaches: one group receives robotic-assisted upper limb rehab with the Gloreha Sinfonia® exoskeleton plus conventional therapy, while the other group gets only conventional therapy. The main goal is to see which method better improves motor control and coordination.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Group (EG)Experimental Treatment1 Intervention
Group II: Control Group (CG)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

IRCCS San Raffaele Roma

Lead Sponsor

Trials
56
Recruited
354,000+

Published Research Related to This Trial

Robot-assisted training for both upper and lower limbs is currently the most promising method for restoring motor function after a stroke, as shown by various clinical trials of devices like MIT-Manus and Lokomat.
Patients who undergo robot-assisted training combined with traditional physiotherapy show greater improvements in motor function compared to those who receive only physiotherapy or only robotic training.
Transfer of scientific concepts to clinical practice: recent robot-assisted training studies.Waldner, A., Tomelleri, C., Hesse, S.[2019]
The study involved three ambulatory adult stroke survivors who used a new wearable robotic knee orthosis (RKO) during 18 sessions over six weeks, leading to significant improvements in balance, gait, and functional performance.
All participants showed positive outcomes, with average improvements of 12.6% in the Berg Balance Scale, 12.0% in the six-minute walk test, and 16.7% in the Emory Functional Ambulation Profile, and importantly, no adverse events were reported.
A wearable robotic knee orthosis for gait training: a case-series of hemiparetic stroke survivors.Wong, CK., Bishop, L., Stein, J.[2016]

Citations

Effects of robot assistive upper extremity rehabilitation on motor and cognitive recovery, the quality of life, and activities of daily living in stroke patients. [2019]
Interactive robots for neuro-rehabilitation. [2016]
Robot-based hand motor therapy after stroke. [2016]
Overview of clinical trials with MIT-MANUS: a robot-aided neuro-rehabilitation facility. [2018]
Transfer of scientific concepts to clinical practice: recent robot-assisted training studies. [2019]
Robotic hand treatment of patients affected by chronic stroke: a monocentric longitudinal pilot study. [2021]
Changes in skeletal muscle perfusion and spasticity in patients with poststroke hemiparesis treated by robotic assistance (Gloreha) of the hand. [2020]
Hand motion analysis during robot-aided rehabilitation in chronic stroke. [2021]
A wearable robotic knee orthosis for gait training: a case-series of hemiparetic stroke survivors. [2016]
Safety, Feasibility and Efficacy of Lokomat® and Armeo®Spring Training in Deconditioned Paediatric, Adolescent and Young Adult Cancer Patients. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security