Sensory and Cognitive Outcomes of Robotic Exercises in Stroke (SCORES)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robotic Rehabilitation of the upper limb, Conventional Rehabilitation of the upper limb.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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).
Interventions
- Other Robotic 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 - Other Conventional Rehabilitation of the upper limb
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.
Primary outcome measures
- Changes in Montreal Cognitive Assessment [Time frame: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention]
Secondary outcome measures (12)
- Changes in Montreal Cognitive Assessment [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 [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 [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 [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 [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) [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 [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 [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) [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 [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 [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 [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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Italy · 3 centers
- IRCCS Fondazione Don Carlo Gnocchi — Florence
- IRCCS Centro Neurolesi Bonino Pulejo — Messina
- Fondazione Don Carlo Gnocchi - Centro Santa Maria della Provvidenza — Roma
Identifiers
NCT: NCT06109324 · SCORES_clinicalstudy