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Robotic Rehabilitation for Upper Limb Recovery After Stroke

This study is looking at how well robotic-assisted therapy helps people recover movement in their arm and hand after a stroke. It's comparing a treatment that combines Robotic Assisted Upper Limb Rehabilitation with regular physical and occupational therapy to just regular therapy alone. You might be able to join if you are between 18 and 85 years old and have some weakness in your arm or hand from a recent stroke (within 90 days). The main goal is to see if the robotic therapy improves your arm and hand movement more, using a score called the Fugl Meyer Assessment for Upper Limb. The study is currently unclear about its status, but plans to enroll 130 participants.

Study design
This is a randomized controlled trial, meaning participants will be randomly assigned to one of two groups. It plans to include 130 participants.
What's involved
You would participate in 90 minutes of therapy daily. Your arm and hand movement will be measured at the start, after 35 days of treatment, and again 3 months after treatment.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be checked 3 months after your treatment ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06839482

Robotic Rehabilitation of the Upper Limb in Subacute Stroke

Recruiting
NAAges 18–85InterventionalTreatment
IRCCS San Raffaele Roma
~130 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:Robotic Assisted Upper Limb RehabilitationControl Group (CG)

At a glance

Recruiting sites
1 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fugle Meyer Assessment for Upper Limb - Motor Part (score range: 0-66)
Measured over Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)

Conditions

Stroke

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Stroke

NCT06839482

Where you'd take part

This study runs at 21 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Agel Hospital Prostějov, Rehabilitation Centre, Mathonova 1, Clinical Rehabilitation Centre FZV UP, Hněvotínská 3

    Olomouc, Czechiastudy coordinator listed

    Not yet recruiting

  • ASST Papa Giovanni XXIII

    Bergamo, Italystudy coordinator listed

    Not yet recruiting

  • Centro Lescer, Occupational Therapy and Physical Therapy Department

    Madrid, Spainstudy coordinator listed

    Not yet recruiting

  • Charles University and General University Hospital in Prague

    Prague, Czechiastudy coordinator listed

    Not yet recruiting

  • Chiang Mai University, Department of Occupational Therapy, Faculty of Associated Medical Sciences

    Chiang Mai, Thailandstudy coordinator listed

    Not yet recruiting

  • Department of Rehabilitative Medicine, AUSL Piacenza

    Fiorenzuola d'Arda, PC, Italystudy coordinator listed

    Not yet recruiting

  • European Society of Physical and Rehabilitation Medicine, SISC in New Technologies and Robotics in Rehabilitation

    Rome, Choose One..., Italystudy coordinator listed

    Not yet recruiting

  • Fondazione Policlinico Universitario Campus Bio-Medico di Roma, UOC di Medicina Fisica e Riabilitativa-CESA

    Rome, RM, Italystudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sanaz Pournajaf, DPT, PhD · PRINCIPAL_INVESTIGATOR · IRCCS San Raffaele Roma

Who to contact

Sanaz Pournajaf, DPT, PhD
[email protected]
+39 0652252405 · ext. 32405
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

Presence of other overlapping neurological disorders
Presence of osteoarticular or neuromuscular disorders affecting upper limb mobility
Severe psychiatric disorders
Severe cognitive (MMSE ≤ 17) and/or language impairment compromising exercise comprehension
Botulinum toxin injection in the affected upper limb within the last 60 days or planned during the study and follow-up period
Open wounds, infections, or unprotected skin lesions on the upper limb
Severe spasticity of the upper limb (biceps and wrist and finger flexors) (MAS \> 3)
Inability to adhere to the exercise program due to low compliance
Participants who have not signed the informed consent for the study

What this trial measures

  • Fugle Meyer Assessment for Upper Limb - Motor Part (score range: 0-66)Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)

    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index designed to evaluate motor function, balance, sensation, and joint integrity in individuals with post-stroke hemiplegia. It is widely used in both clinical and research settings to assess disease severity, track motor recovery, and guide treatment planning. In this study, the Motor Part of the FMA for the Upper Limb is the primary outcome measure, with scores ranging from a minimum of 0 to a maximum of 66. A higher score indicates better motor function on the impaired side.