Clinical trial NCT05280431: Evaluation of Exoskeleton for Upper Limb Rehabilitation in Neurological Patients
Official title: Evaluation of the Use of Exoskeleton Systems for Upper Limb Rehabilitation in Neurological Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Neurologic Disorder
Lead sponsor: Casa di Cura Privata del Policlinico SpA
Sponsor class: OTHER
Collaborators: name: Politecnico di Milano
name: Fundación Tecnalia Research & Innovation
First posted: 2022-03-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: System Usability Scale (SUS)
timeFrame: up to 5 weeks
Secondary outcomes:
measure: Technology Assessment Methods (TAM)
timeFrame: up to 5 weeks
measure: Virtual Reality Questionnaire (VR)
timeFrame: up to 5 weeks
measure: Fugl-Meyer Assessment Scale (FMA-UE)
timeFrame: up to 5 weeks
measure: Action Research Arm Test (ARAT)
timeFrame: up to 5 weeks
measure: Modified Ashworth Scale (MAS)
timeFrame: up to 5 weeks
measure: Motricity Index (MI)
timeFrame: up to 5 weeks
measure: Visual Analogue Scale (VAS)
timeFrame: up to 5 weeks
measure: Box and Block Test (BBT)
timeFrame: up to 5 weeks
measure: Nine Hole Peg Test (9HPT)
timeFrame: up to 5 weeks
measure: Number of Peaks (#Peaks) of the speed profile
timeFrame: up to 5 weeks
measure: Smoothness described by the Teulings's index (TI)
timeFrame: up to 5 weeks
measure: The absolute hand path error (e)
timeFrame: up to 5 weeks
measure: Event-Related Desynchronization and Synchronization (ERD/ERS) of the μ and β rhythms
timeFrame: up to 5 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Casa di Cura del Policlinico
state: MI
Study officials:
References: