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

Evaluation of the Use of Exoskeleton Systems for Upper Limb Rehabilitation in Neurological Patients

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Neurologic Disorder
• Intervention / Treatment: Device: AGREE exoskeleton; Device: FEXO exoskeleton; Other: Conventional therapy

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20144
      • Casa di Cura del Policlinico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group (AGREE); 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.	Device: AGREE exoskeleton; Upper limb exoskeleton with four actuated degrees of freedom (shoulder horizontal adduction/abduction, shoulder flexion/extension, humeral rotation, elbow flexion/extension), and one passive degree of freedom (wrist pronation/supination), implementing different rehabilitative strategies. The intervention consists of the execution of different exercises with the affected arm supported by the AGREE device. The subject is actively involved in the exercises and the system provides different kinds of assistance that can be tailored according to the patient's status. The following exercises can be performed: anterior reaching (in a plane or in the space); lateral elevation of the arm; hand to mouth movements with or without an object in the hand; moving objects (on a plane or in the space); exergames. A subset of exercises is defined based on the patient's capability.
Experimental: Experimental Group (FEXO); 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.	Device: FEXO exoskeleton; After patient's preparation (tDCS and FES) the FEXO assessment is conducted. The subject performs FEXO assessment games. This stage is also used to calibrate the reach and grasp movement intention EEG patterns. The movement is recorded using internal kinematic sensors; therefore, these measures can be extracted for both reaching and lifting movements. Trunk forward bending is measured to avoid compensatory movements when doing reaching assessment. The clinician then reviews the plan for today's session: game selection, number of repetitions and assistance levels. The patient gets ready to play the games and the clinician starts the first activity of the active stage of FEXO therapy. The patient plays the game and sees his own results. The clinician monitors patient activity, assistance levels, effort and signs of discomfort. The patient plays the next game and sees his own results, and the clinician checks the patient's progress with the results overview.
Other: Control Group (Conventional therapy); 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.	Other: Conventional therapy; It consists of a combination of different treatment modalities among the following, based on the patient's specific needs: Upper limb passive motion; Occupational therapy exercises; Constraint-induced movement therapy; Upper limb active movement (reaching, grasping, elevation, spatial orientation); Repetitive task training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability Scale (SUS)	SUS is used to measure how easy or difficult the proposed system is to use	up to 5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technology Assessment Methods (TAM)	TAM is an information systems theory that models how users come to accept and use a technology	up to 5 weeks
Virtual Reality Questionnaire (VR)	VR is used to measure how easy or difficult the virtual reality interface is to use	up to 5 weeks
Fugl-Meyer Assessment Scale (FMA-UE)	FMA-UE assesses sensorimotor status including items assessing upper extremity motion, balance, sensation and range of movement	up to 5 weeks
Action Research Arm Test (ARAT)	ARAT is used to assess upper extremity performance (coordination, dexterity and functioning)	up to 5 weeks
Modified Ashworth Scale (MAS)	MAS is used to muscle quantified spasticity	up to 5 weeks
Motricity Index (MI)	MI is used to grade motor activity in muscles of the upper limb	up to 5 weeks
Visual Analogue Scale (VAS)	VAS is a psychometric response scales used to measure subjective pain	up to 5 weeks
Box and Block Test (BBT)	BBT measures unilateral gross manual dexterity. The BBT administration consists of asking the subject to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds	up to 5 weeks
Nine Hole Peg Test (9HPT)	9HPT is used to measure finger dexterity in patients. The 9HPT administration consist of asking the subject to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible	up to 5 weeks
Number of Peaks (#Peaks) of the speed profile	If a point-to-point reaching movement has a low number of peaks, it means that few acceleration and deceleration periods are present	up to 5 weeks
Smoothness described by the Teulings's index (TI)	TI s the rate of change of the acceleration in a movement; a lower value of TI indicates a smoother movement	up to 5 weeks
The absolute hand path error (e)	e is the area between the actual movement path and the straight line; this was considered an index of learning and a reduction of e indicates a better adaptation to the required task.	up to 5 weeks
Event-Related Desynchronization and Synchronization (ERD/ERS) of the μ and β rhythms	Motor processing can result in changes of the ongoing EEG in form of an event-related desynchronization (ERD) or event-related synchronization (ERS). Spatial mapping of ERD/ERS can be used to study the dynamics of cortical activation patterns	up to 5 weeks

Collaborators and Investigators

• Sponsor: Casa di Cura Privata del Policlinico SpA
• Collaborators: Politecnico di Milano; Fundación Tecnalia Research & Innovation

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: PCP_EXOs_

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No