Clinical trial NCT06109324: Sensory and Cognitive Outcomes of Robotic Exercises in Stroke (SCORES)
Official title: A Multicenter Randomized Controlled Trial on the Effects of Upper Limb Robotic Rehabilitation on Sensory and Cognitive Impairments in Subjects With Stroke. The SCORES (Sensory and Cognitive Outcomes of Robotic Exercises in Stroke) Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: robotics
cognition
rehabilitation
upper extremity
sensorimotor
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: IRCCS Centro Neurolesi Bonino Pulejo
name: Scuola Superiore Sant'Anna di Pisa
First posted: 2023-10-31
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* a single event, verified by MRI or CT;
* age between 18 and 85 years;
* time since stroke within six months;
* a demographically adjusted total score of the Montreal Cognitive Assessment (MoCA) between 15.5 and 22.23

Exclusion Criteria:

* behavioural and cognitive disorders and/or reduced compliance that would interfere with active therapy;
* fixed contraction deformity in the affected limb that would interfere with active therapy (ankylosis, Modified Ashworth Scale = 4);
* severe deficits in visual acuity.

Primary outcomes:
measure: Changes in Montreal Cognitive Assessment
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention
Secondary outcomes:
measure: Changes in Montreal Cognitive Assessment
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in Symbol Digit Modalities Test
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in Tower of London
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in Rey-Osterrieth Complex Figure test
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in Visual search test
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in Fugl-Meyer Assessment of the Upper Extremity (motor score)
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in Thumb Localizing Test
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in Semmes Weinstein filament test
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in Fugl-Meyer Assessment of the Upper Extremity (sensation score)
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in Box and Block test
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in Motricity Index
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in Modified Barthel Index
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in Numerical Rating Scale for Pain
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in Neuropathic Pain Symptom Inventory
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in Douleur Neuropathique 4
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in Post-stroke Depression Rating Scale
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in Intrinsic Motivation Inventory
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Other outcomes:
measure: Changes in robotic score duration
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in robotic score speed
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in robotic score length
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in robotic score useful work
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in robotic score strength
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in robotic score finger strength (flexion and extension)
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in robotic score muscle tone at rest
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in matching test mean error
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
measure: Changes in matching test variability
timeFrame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Locations:
city: Firenze
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi Bonino Pulejo
city: Roma
country: Italy
facility: Fondazione Don Carlo Gnocchi - Centro Santa Maria della Provvidenza
Study officials:
affiliation: IRCCS Fondazione Don Carlo Gnocchi
name: Marco Germanotta, PhD
role: STUDY_DIRECTOR
References: