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

NCT06109324 | Recruiting

• 1 other identifier: SCORES_clinicalstudy
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 3

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.

Conditions

Stroke

Keywords

robotics; cognition; rehabilitation; upper extremity; sensorimotor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Changes in Montreal Cognitive Assessment

  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

  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

  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

  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

  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 (9)

• Changes in robotic score duration

  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

  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

  Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention

Study Arms (2)

Robotic Rehabilitation

EXPERIMENTAL

Other: Robotic Rehabilitation of the upper limb

Conventional treatment

ACTIVE COMPARATOR

Other: Conventional Rehabilitation of the upper limb

Interventions

Robotic Rehabilitation of the upper limb OTHER

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.

Robotic Rehabilitation

Conventional Rehabilitation of the upper limb OTHER

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.

Conventional treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• IRCCS Centro Neurolesi Bonino Pulejo: collaborator
• Scuola Superiore Sant'Anna di Pisa: collaborator

Study Sites (3)

IRCCS Fondazione Don Carlo Gnocchi

Florence, 50143, Italy

RECRUITING

IRCCS Centro Neurolesi Bonino Pulejo

Messina, 98123, Italy

RECRUITING

Fondazione Don Carlo Gnocchi - Centro Santa Maria della Provvidenza

Roma, 00166, Italy

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marco Germanotta, PhD

  IRCCS Fondazione Don Carlo Gnocchi

  STUDY DIRECTOR

Central Study Contacts

Marco Germanotta, PhD

CONTACT

+390633086553; mgermanotta@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 31, 2023
• Study Start: November 13, 2023
• Primary Completion: May 1, 2025
• Study Completion: January 1, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

IT (3)