Robotic Rehabilitation for Stroke

(GLORIA Trial)

Not currently recruiting at 22 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: IRCCS San Raffaele Roma

Must not be taking: Botulinum toxin

Disqualifiers: Neurological, Osteoarticular, Psychiatric, Cognitive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a robotic exoskeleton called Gloreha Sinfonia® to help individuals regain arm and hand movement after a recent stroke. Researchers aim to determine if this robotic therapy, combined with regular rehab exercises, surpasses standard rehab exercises alone. The goal is to improve motor skills such as muscle strength, coordination, and independence in daily activities. The study is open to those who have experienced a stroke within the last 90 days and have mild to moderate weakness in their arm and hand. Participants will undergo assessments before, immediately after, and three months following the treatment. As an unphased trial, this study offers a unique opportunity to explore innovative rehabilitation methods that could enhance recovery.

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.

What prior data suggests that the Gloreha Sinfonia® robotic exoskeleton is safe for upper limb rehabilitation?

Research has shown that robotic rehabilitation, such as the Gloreha Sinfonia®, is generally safe for helping stroke patients regain movement skills. Studies indicate that this therapy enables more frequent and intense exercises, improving strength and coordination. Importantly, similar therapies have not reported major harmful effects, making them well-tolerated. While specific data on side effects for Gloreha Sinfonia® is not available, the overall safety of robotic rehabilitation remains reassuring. For any concerns, participants should discuss them with the trial team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the robotic rehabilitation treatment for stroke because it uses the Gloreha Sinfonia, a robotic device designed to assist with upper limb rehabilitation. Unlike most conventional therapies that rely solely on manual exercises and therapist assistance, this device offers a more precise and consistent rehabilitation experience. The Gloreha Sinfonia allows for customizable treatment sessions, with robotic assistance providing repetitive, controlled movements that can enhance motor recovery. This innovative approach could lead to more efficient and potentially faster rehabilitation outcomes for stroke survivors.

What evidence suggests that the Gloreha Sinfonia® robotic exoskeleton is effective for stroke rehabilitation?

Research has shown that the Gloreha Sinfonia robotic device aids in regaining arm function after a stroke. In this trial, participants in the Experimental Group (EG) will receive robotic-assisted treatment with the Gloreha Sinfonia alongside standard rehabilitation. Studies have found that this device boosts strength and increases the range of movement in stroke patients. It also enhances coordination between the eyes and hands, as well as overall motor skills. Patients who used this robotic treatment with regular therapy recovered upper limb function faster. This suggests that the Gloreha Sinfonia could be a valuable tool for improving movement control and coordination after a stroke. ^{1 3 6 7 8}

Who Is on the Research Team?

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.

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

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?

Group I: Experimental Group (EG) Experimental Treatment 1 Intervention

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.

Group II: Control Group (CG) Active Control 1 Intervention

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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A wearable robotic knee orthosis for gait training: a case-series of hemiparetic stroke survivors. Wong, CK., Bishop, L., Stein, J.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12162109/

Effectiveness of Robot-Assisted Upper Extremity Function ... The Gloreha (Idrogenet SRL) is a robotic device that enhances conventional rehabilitation for improving upper extremity function after stroke.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06839482

Robotic Rehabilitation of the Upper Limb in Subacute Stroke It is hypothesized that robotic treatment with Gloreha Sinfonia R-Touch Pro will significantly improve strength, active range of motion, eye-hand coordination, ...

3. mdpi.com mdpi.com/2076-3417/12/9/4206

Robotic-Assisted Hand Therapy with Gloreha Sinfonia for ... In fact, to date, no studies have investigated the efficacy of Gloreha in the motor recovery of hand functions in children after stroke.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2023/7991765

Effectiveness of Robotics in Stroke Rehabilitation to ... The primary outcome measure examined in this review was the speed of the UE functional recovery postrobotic therapy with concurrent CT. Speed of ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666459325000447

Functional and motoric outcome of AI-assisted stroke ... AI-assisted stroke rehabilitation shows promising outcomes in terms of functional and motoric outcomes. Barthel and Motricity Index are used in this study.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12265130/

Upper limb robotic rehabilitation following stroke: a systematic ... The results suggest that robotic rehabilitation does not result in clinically meaningful improvement in either upper limb capacity or ADL performance.

7. gloreha.us gloreha.us/robotic-rehabilitation/

Robotic Rehabilitation Improved motor recovery: Robotic rehabilitation allows for more intense and repeated exercises, promoting the recovery of strength, coordination, and ...

8. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/585358

Robotic Rehabilitation Vs Occupational Therapy Chronic ... Group A will receive rehabilitative treatment using the Gloreha Sinfonia system . The treatment regimen spans five weeks and encompasses a ...