Evaluation of Exoskeleton for Upper Limb Rehabilitation in Neurological Patients (PCP_EXOs)

Casa di Cura Privata del Policlinico SpA

Status: Completed

Conditions: Stroke; Neurologic Disorder

Treatments: Device: FEXO exoskeleton; Device: AGREE exoskeleton; Other: Conventional therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05280431

PCP_EXOs_

Details and patient eligibility

About

Acquired cerebrovascular trauma is the third most common cause of disability worldwide, resulting in long-term disability, limitation of activities of daily living, and reduced social participation. It is estimated that, within three months of the acute event, a high percentage of patients do not recover full function. 93% of these disabilities concern the upper limb.

To induce optimal functional reorganization after the acute cerebrovascular events or neurodegenerative diseases affecting the central nervous system, robotic assistance allows intensive exercises with specific therapeutic purposes. Indeed, they enable an intensive, repetitive, and customizable therapeutic program that is in line with the principles underlying motor learning.

Clinical investigation is needed to assess the efficacy of the proposed new technologies (AGREE and FEXO exoskeleton) and to guide subsequent developmental steps. Therefore, an exploratory clinical study is proposed to evaluate usability, tolerability, and safety, as well as to assess the effectiveness of the new technologies.

The primary objective of this study is to examine the safety and tolerability of the new active exoskeletons for upper extremity rehabilitation and validate them in a controlled environment. Furthermore, efficacy will be examined as the secondary outcome.

Enrollment: 48 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age between 18 and 85 years;
• motor deficit of the upper limb induced by neurological diseases (e.g., stroke, multiple sclerosis);
• time since the acute event of at least one month;
• Trunk Control Test score ≥ 48.

Exclusion criteria

• global aphasia;
• presence of cognitive impairment;
• severe unilateral spatial neglect;
• Box and Block test < 1;
• Ashworth scale score ≥ 4;
• total or severe impairment of visual acuity;
• instability of clinical parameters or presence of severe comorbidities;
• inadequate anthropometric measurements;
• presence of any serious condition that may affect participation in the study (e.g., oncological, hepatic/renal, immune, metabolic/endocrine, psychiatric, respiratory or infectious disorders);
• inability to comply with the protocol or to give informed consent.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 3 patient groups

Experimental Group (AGREE)

Experimental group

Description:

15 sessions, 3 sessions per week. Each session consists of 45 minutes of training with the AGREE exoskeleton. The training session is customized to the patient's needs and can be adapted to his/her improvement during the intervention.

Treatment:

Device: AGREE exoskeleton

Experimental Group (FEXO)

Experimental group

Description:

15 sessions, 3 sessions per week. Each session consists of 45 minutes of training with the FEXO exoskeleton. The training session is customized to the patient's needs and can be adapted to his/her improvement during the intervention.

Treatment:

Device: FEXO exoskeleton

Control Group (Conventional therapy)

Other group

Description:

15 sessions, 3 sessions per week. Each session consists of 45 minutes and consists of different training modalities typically used in the rehabilitation of the arm after stroke.

Treatment:

Other: Conventional therapy