Robotic Rehabilitation of the Upper Limb in Subacute Stroke
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorIRCCS San Raffaele Roma
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Robotic Assisted Upper Limb Rehabilitation
DeviceThe EG will follow a mixed rehabilitation approach for the upper limb, combining Robotic Assisted Upper Limb Rehabilitation and conventional physical therapy (PT) and/or occupational therapy (OT) with a total daily duration of 90 minutes. The Robotic Assisted UL Rehabilitation's session will last 30 minutes, with the following procedure provided: * First week: alternate between passive mobilization exercises, bilateral mode, and therapist-driven mode. * Second week: alternate between therapist-driven mode and active-assisted mobilization. * Third week: alternate between active-assisted mobilization and active mobilization. * Fourth week: alternate between active-assisted mobilization and active mobilization. * Fifth week: exclusively perform active mobilization. However, if this proposed progression does not match the patient's motor capabilities, the therapist will optimize the therapeutic program by selecting personalized exercises, following a progressive difficulty approach.
Control Group (CG)
Other interventionThe CG will follow a conventional occupational therapy (OT) and physical therapy (PT) program for upper limb rehabilitation, with a total daily duration of 90 minutes. Upper limb rehabilitation exercises will be performed with a therapist who will tailor the treatment according to the patient's clinical characteristics and needs. Specifically, upper limb treatment will consist of motor exercises (shoulder, elbow, wrist, and hand) through a mix of individual sessions with both passive and active interventions where possible.
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: Experimental Group (EG)Experimental treatment 1 intervention
Group B: Control Group (CG)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Fugle Meyer Assessment for Upper Limb - Motor Part (score range: 0-66)
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.
Time frame
Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)Secondary outcomes
1
National Institute of Health Stroke Scale (NHISS)
The National Institutes of Health Stroke Scale (NIHSS) is a systematic, quantitative assessment tool to measure stroke-related neurological deficit. Its score ranges from 0 to 42, where higher scores indicate greater neurological impairment. In clinical practice it can be used to evaluate and document neurological status in acute stroke patients, determine appropriate treatment and assist in standardizing communication between healthcare practitioners. The NIHSS has been shown to be a predictor of both short and long term outcomes of stroke patients.
Time frame
Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)2
Pain scale (NRS 0-10) - at passive mobilization
Scores range from 0 to 10, where 0 indicates no pain and 10 represents the worst pain intensity the individual has ever experienced.
Time frame
Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)3
Modified Ashworth Scale (MAS)
The Modified Ashworth Scale (MAS) is used to assess spasticity. The Modified Ashworth Scale (MAS) has been utilised in the following populations: stroke, spinal cord injury, multiple sclerosis, cerebral palsy, traumatic brain injury, paediatric hypertonia and central nervous system lesions. The test is performed by extending the patients limb's first from a position of maximal possible flexion to maximal possible extension (the point at which the first soft resistance is met). Afterwards, the modified Ashworth scale is assessed while moving from extension to flexion. Scores range from 0 to 4, where 0 indicates no increase in muscle tone and 4 represents a limb that is rigid in flexion or extension.
Time frame
Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)4
Medical Research Council Scale (MRC)
The Medical Research Council (MRC) Scale for Muscle Strength is a commonly used scale for assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction). The Criteria requires that each of the six muscle groups listed in the table are examined bilaterally, each with a score from 0 to 5 according to the scale in the right hand column.
Time frame
Day 0 (T1- basline), day 35 (T2 - After treatment), and day 125 (T3 - 3 months after treatment Follow-Up)Other outcomes
1
IMU-based targeted Box and Block Test (t-BBT)
Instrumental assessment of manual dexterity will be conducted using a sensorized and modified version of the Box and Block Test (BBT). This modified version involves moving 10 cubes from one side of the box to the other positioned on a 5x2 grid. In a subset of EG subjects, kinematic parameters will be measured using Inertial Measurement Units (IMUs), and electrophysiological parameters will be recorded via surface electromyography (sEMG). The assessment will quantify joint kinematics, including range of motion and movement smoothness, as well as upper limb muscle activation patterns, such as muscle onset timing and co-contraction levels. This approach enables a comprehensive evaluation of motor performance during the BBT.
Time frame
Day 0 (T1- basline), and day 35 (T2 - After treatment)Sponsors and contacts
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Source ClinicalTrials.gov