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

Last updated: October 10, 2024
Sponsor: Fondazione Don Carlo Gnocchi Onlus
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Conventional Rehabilitation of the upper limb

Robotic Rehabilitation of the upper limb

Clinical Study ID

NCT06109324
SCORES_clinicalstudy
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • behavioural and cognitive disorders and/or reduced compliance that would interferewith active therapy;

  • fixed contraction deformity in the affected limb that would interfere with activetherapy (ankylosis, Modified Ashworth Scale = 4);

  • severe deficits in visual acuity.

Study Design

Total Participants: 126
Treatment Group(s): 2
Primary Treatment: Conventional Rehabilitation of the upper limb
Phase:
Study Start date:
November 13, 2023
Estimated Completion Date:
January 31, 2026

Study 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).

Connect with a study center

  • IRCCS Fondazione Don Carlo Gnocchi

    Firenze, 50143
    Italy

    Active - Recruiting

  • IRCCS Centro Neurolesi Bonino Pulejo

    Messina, 98123
    Italy

    Active - Recruiting

  • Fondazione Don Carlo Gnocchi - Centro Santa Maria della Provvidenza

    Roma, 00166
    Italy

    Active - Recruiting

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