NCT06547827 Rehabilitation With and Without Robot and Allied Digital Technologies in Stroke Patients
| NCT ID | NCT06547827 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Don Carlo Gnocchi ETS |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 596 participants |
| Start Date | 2024-08-12 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 596 participants in total. It began in 2024-08-12 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Rehabilitation after stroke often employs Robot and Allied Digital Technologies (RADTs), yet evidence on their effectiveness remains inconclusive due to study heterogeneity and limited sample sizes. This multicentre randomized controlled pragmatic trial aims at comprehensively and accurately assessing the effectiveness of rehabilitation mediated by RADTs after a stroke, compared to traditional rehabilitation, also considering economic sustainability.
Eligibility Criteria
Inclusion Criteria: * First-ever diagnosis of ischemic or haemorrhagic stroke confirmed by Computed Tomography or Magnetic Resonance Imaging; * Age 18 years and over; * Time since the event equal to or less than 6 months; * Mild to severe impairment of the upper limb (motor section of the Fugl-Meyer Assessment of Upper Extremity ≤ 58) and/or mild to severe impairment of the lower limb (score on the Functional Ambulation Categories scale ≤ 4) and/or mild to severe impairment of balance (Berg Balance Scale ≤ 45); * Clinical stability allowing transfer to the gym and execution of the planned treatments. Exclusion Criteria: * Clinical instability; * Behavioral/cognitive disorders preventing adequate patient compliance with both traditional and robotic rehabilitation treatment (severe cognitive deficit, Montreal Cognitive Assessment \<10); * Rigidity or hypertonia (Modified Ashworth Scale \> 3) in the plegic/paretic limb; * Serious uncorrectable visual impairments preventing the patient from performing treatment with technological and/or robotic devices; * Pregnant women; * Refusal to sign the informed consent.
Contact & Investigator
Irene G Aprile
STUDY DIRECTOR
IRCCS Fondazione Don Carlo Gnocchi
Frequently Asked Questions
Who can join the NCT06547827 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06547827 currently recruiting?
Yes, NCT06547827 is actively recruiting participants. Contact the research team at iaprile@dongnocchi.it for enrollment information.
Where is the NCT06547827 trial being conducted?
This trial is being conducted at Acerenza, Italy, Bari, Italy, Genova, Italy, Milan, Italy and 9 additional locations.
Who is sponsoring the NCT06547827 clinical trial?
NCT06547827 is sponsored by Fondazione Don Carlo Gnocchi ETS. The principal investigator is Irene G Aprile at IRCCS Fondazione Don Carlo Gnocchi. The trial plans to enroll 596 participants.
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