Sensory and Cognitive Outcomes of Robotic Exercises in Stroke (SCORES)

Stroke Clinical Trial

— 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06109324
• Other study ID #: SCORES_clinicalstudy
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: January 2026

Study information

• Verified date: October 2023
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Marco Germanotta, PhD
• Phone: +390633086553
• Email: mgermanotta[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: January 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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, 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.
• 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.

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Don Carlo Gnocchi	Firenze
Italy	IRCCS Centro Neurolesi Bonino Pulejo	Messina
Italy	Fondazione Don Carlo Gnocchi - Centro Santa Maria della Provvidenza	Roma

Sponsors (3)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus	IRCCS Centro Neurolesi "Bonino-Pulejo", Scuola Superiore Sant'Anna di Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Other	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.	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Other	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).	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Other	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.	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Other	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	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Other	Changes in robotic score finger strength (flexion and extension)	It is the isometric strength for the hand, in both flexion and extension	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Other	Changes in robotic score muscle tone at rest	It is the passive baseline force of the finger muscles.	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Other	Changes in matching test mean error	The mean value of the absolute differences between the actual and the desired positions.	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Other	Changes in matching test variability	The standard deviation of the matching errors across trials.	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Primary	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).	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention
Secondary	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).	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Secondary	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.	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Secondary	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.	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Secondary	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)	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Secondary	Changes in Visual search test	It is a validated measure of visual attention.	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Secondary	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).	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Secondary	Changes in Thumb Localizing Test	It is a standardised measure of proprioception. It ranges from 0 (normal) to 3.	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Secondary	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.	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Secondary	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).	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Secondary	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.	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Secondary	Changes in Motricity Index	It is a validated measure of upper limb strength. It ranges from 0 (worse) to 100 (normal strength).	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Secondary	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.	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Secondary	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).	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Secondary	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)	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Secondary	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.	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Secondary	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)	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention
Secondary	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	Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention