An interventional study of Robotic Rehabilitation of the upper limb and Conventional Rehabilitation of the upper limb in Stroke, sponsored by Fondazione Don Carlo Gnocchi Onlus. Recruiting at 3 sites in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Fondazione Don Carlo Gnocchi Onlus · Not applicable, Interventional, and Treatment
Based on the findings of meta-analyses, upper limb robotic rehabilitation has shown to enhance daily living activities, motor function, and strength in stroke patients. However, when compared to traditional methods, recent randomized controlled trials conducted on larger participant groups failed to identify significant differences in motor-related outcomes between the two approaches.
In addition to motor deficits, stroke survivors often experience cognitive decline and sensory disturbances, which can significantly impede their recovery process. The introduction of multisensory stimulation and an enriched environment through robotic interventions may offer valuable supplementary treatments in these specific areas. Nevertheless, this aspect of treatment has not been thoroughly explored.
This study seeks to assess the effectiveness of upper limb robotic rehabilitation in individuals recovering from subacute strokes, in comparison to conventional treatments. Specifically, it aims to determine whether this robotic therapy can lead to improvements in (a) cognitive deficits, (b) somatosensory impairment, and (c) how these sensory and cognitive deficits influence the process of motor recovery.
The study aims to investigate whether an upper limb robotic treatment could have a greater impact than a conventional approach on specific cognitive domains in patients with stroke, as well as in restoring the somatosensory impairment in patients with stroke.
For this aim, 126 consecutive subjects with stroke in the sub-acute phase (within 6 months after stroke) will be enrolled and randomized to either the robotic (RG) or the conventional group (CG). The sample size was calculated by means of a 2- sided, 2-sample t-test assuming: 80% power; type I error of 0.05; a mean difference of 2.15 units on the MoCA, a common standard deviation of 3.77 points (Wu 2019). Considering a dropout rate of 20%, the final sample size required was estimated to be 126 subjects.
Randomization will be stratified according to a cut-off of 18.28 on the MoCA demographically adjusted total score (inner confidence limit of the 5th centile of the normal population) indicating a borderline performance, to ensure that the subjects' characteristics in each group will be closely matched. In the RG, patients will undergo robotic therapy, while a conventional approach will be used in the CG. The rehabilitation treatments, either robotic or conventional, will be performed daily for 45 minutes, 5 days/week, for a total of 30 sessions. Patients in the RG will be treated using a set of devices that allow bi- and three-dimensional movements of the shoulder, elbow, wrist, and fingers (Aprile et al, 2019). Motor and cognitive tasks, carefully selected among those available, will be performed during the treatment, following a protocol already proposed in a previous pilot study (Aprile et al, 2021). Visual and auditory feedback will be provided to help the patients. In the RG, treatment will focus on reprogramming sensorimotor function, hypertonus inhibition, and functional improvement. Patients will be evaluated at baseline (T0), the end of the rehabilitation protocol (T1), and a 6-month follow-up (T2).
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 126 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.
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Exclusion Criteria:
Other: Robotic Rehabilitation of the upper limb
Other: Conventional Rehabilitation of the upper limb
Upper limb rehabilitation using a set of 4 devices. A set of motor/cognitive exercises will be selected to train also attention, memory, executive function, speed of processing, and visuospatial abilities.The following devices will be used: (a) a robotic device that allows passive, active, and active-assistive planar movements of the shoulder and elbow joints (Motore, Humanware); (b) a robotic device that allows passive, active, and active-assistive finger flexion and extension movements (Amadeo, Tyromotion); (c) a sensor-based system that allows unsupported 3-dimensional movements of shoulder, elbow, and wrist joint, both unimanual and bimanual (Pablo, Tyromotion); and (d) a robotic system that allows 3-dimensional, unimanual and bimanual, movements of the shoulder joint, with arm weight support (Diego, Tyromotion). The rehabilitation treatment will be performed daily for 45 minutes, 5 days/week, for a total of 30 sessions.
Upper limb rehabilitation using conventional techniques, focused on upper limb reprogramming sensorimotor function, hypertonus, inhibition and functional improvement. The rehabilitation treatment will be performed daily for 45 minutes, 5 days/week, for a total of 30 sessions.
Changes in Montreal Cognitive Assessment
It is a validated test of cognitive impairment. It ranges from 0 (indicating worse cognitive function) to 30 (best cognitive function).
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention
Changes in Montreal Cognitive Assessment
It is a validated test of cognitive impairment. It ranges from 0 (indicating worse cognitive function) to 30 (best cognitive function).
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Symbol Digit Modalities Test
The Symbol Digit Modalities Test evaluates information processing speed. It consists of a simple task of replacing symbols with numbers. Using a reference key, the patient has 90 seconds to match a sequence of symbols with the correspondent numbers as rapidly as possible. Both written or oral administration can be used. For each correct answer, a point is assigned.
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Tower of London
The Tower of London test is a tool to assess strategic decision and problem solving. The patient is required to move different colored balls on the three pegs of different lengths, according to a model and a number of established moves. The maximum time for each configuration is 60 seconds.
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Rey-Osterrieth Complex Figure test
The Rey-Osterrieth Complex Figure is a neuropsychological assessment for evaluation of visuospatial abilities, memory, attention, planning, working memory and executive functions. The patient is required to copy a complex figure freehand (recognition), and then draw it from memory (recall). The score is assigned based on the correctness of each line (from 0 to 2)
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Visual search test
It is a validated measure of visual attention.
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Fugl-Meyer Assessment of the Upper Extremity (motor score)
It is a stroke-specific, performance-based impairment index. It ranges from 0 (hemiplegia) to 66 points (normal).
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Thumb Localizing Test
It is a standardised measure of proprioception. It ranges from 0 (normal) to 3.
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Semmes Weinstein filament test
It measure the level of light touch sensation of the tips of the thumb and index finger. The Semmes Weinstein filament test kit consists of 20 flexible nylon monofilaments of constant length, but varying in diameter. They are labeled so as to give a linear scale of perceived intensity (1.65-6.65) using a logarithmic scale of applied force: labeled number = Log10 of (10 × force in milligrams). The more the labeled number increases, the thicker the filament becomes, and the more pressure is necessary to bend the filament.
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Fugl-Meyer Assessment of the Upper Extremity (sensation score)
It is a stroke-specific, performance-based impairment index. It ranges from 0 (no sensation) to 12 points (normal).
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Box and Block test
The Box and Block test is a standard measure for evaluating manual dexterity. The participants grasp and transfer one-inch square blocks from one compartment to the other, transferring as many as possible. The number of blocks transferred from one side to the other within 1 min is recorded.
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Motricity Index
It is a validated measure of upper limb strength. It ranges from 0 (worse) to 100 (normal strength).
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Modified Barthel Index
The modified is an ordinal scale used to measure performance in activities of daily living. It ranges from 0 to 100, with lower scores indicating increased disability.
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Numerical Rating Scale for Pain
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale, from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Neuropathic Pain Symptom Inventory
It is a validated scale for evaluating both peripheral and central neuropathic pain. It ranges from 0 to 100 (most imaginable pain)
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Douleur Neuropathique 4
It is a validated clinician-administered screening tool for neuropathic pain. It ranges from 0 to 10; higher values means higher neuropathic pain probability.
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Post-stroke Depression Rating Scale
It is a validated measure of depression in post-stroke patients. The score ranges from 0 (best) to 45 (worse)
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in Intrinsic Motivation Inventory
The Intrinsic Motivation Inventory (IMI) is a multidimensional measurement method designed to assess participants' subjective experience related to a target activity in laboratory experiments
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in robotic score duration
The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Duration" is the time required to complete the task. It is measured in seconds
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in robotic score speed
The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Velocity_mean" is the average velocity of the device during the test. It is measured in m/s.
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in robotic score length
The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Length_tot" is the global length of the path travelled by the subject during center-out movements. It is measured in meters and it ranges from 0 (no movement) to 2.808 m (patient can fully perform the entire task).
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in robotic score useful work
The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "useful work" is the amount of total work directed towards the target. It is measured in Joules.
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in robotic score strength
The kinetics of the end-effector of the robot will be measured by the robot during reaching tasks performed by the patient against the device. The outcome will be the maximum values towards 8 targets
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in robotic score finger strength (flexion and extension)
It is the isometric strength for the hand, in both flexion and extension
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in robotic score muscle tone at rest
It is the passive baseline force of the finger muscles.
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in matching test mean error
The mean value of the absolute differences between the actual and the desired positions.
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Changes in matching test variability
The standard deviation of the matching errors across trials.
Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
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