Evaluation of Exoskeleton for Upper Limb Rehabilitation in Neurological Patients

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.

Conditions

• Stroke
• Neurologic Disorder

Interventions

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.

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

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

Sponsors & Collaborators

• Politecnico di Milano

  collaborator OTHER

• Fundación Tecnalia Research & Innovation

  collaborator UNKNOWN

• Casa di Cura Privata del Policlinico SpA

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-25

Primary Completion

2023-03-31

Completion

2023-03-31

Countries

• Italy

Study Locations