Evaluation of Exoskeleton for Upper Limb Rehabilitation in Neurological Patients

NCT05280431 | Completed

• 1 other identifier: PCP_EXOs_
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Neurologic Disorder

Outcome Measures

Primary Outcomes (1)

• System Usability Scale (SUS)

  SUS is used to measure how easy or difficult the proposed system is to use

  up to 5 weeks

Secondary Outcomes (13)

• Technology Assessment Methods (TAM)

  up to 5 weeks

• Virtual Reality Questionnaire (VR)

  up to 5 weeks

• Fugl-Meyer Assessment Scale (FMA-UE)

  up to 5 weeks

• Action Research Arm Test (ARAT)

  up to 5 weeks

• Modified Ashworth Scale (MAS)

  up to 5 weeks

Study Arms (3)

Experimental Group (AGREE)

EXPERIMENTAL

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

Experimental Group (FEXO)

EXPERIMENTAL

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

Control Group (Conventional therapy)

OTHER

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

Interventions

AGREE exoskeleton DEVICE

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 Group (AGREE)

FEXO exoskeleton DEVICE

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.

Experimental Group (FEXO)

Conventional therapy OTHER

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

Control Group (Conventional therapy)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Casa di Cura Privata del Policlinico SpA: lead
• Politecnico di Milano: collaborator
• Fundación Tecnalia Research & Innovation: collaborator

Study Sites (1)

Casa di Cura del Policlinico

Milan, MI, 20144, Italy

Location

MeSH Terms

Conditions

Stroke; Nervous System Diseases

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 15, 2022
• Study Start: January 25, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)