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StrokePCP_EXOsNCT05280431

Evaluation of Exoskeleton for Upper Limb Rehabilitation in Neurological Patients

A study testing AGREE exoskeleton, FEXO exoskeleton and Conventional therapy in people with Stroke and Neurologic Disorder, run by Casa di Cura Privata del Policlinico SpA at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stroke, Neurologic Disorder
What is being tested?
AGREE exoskeleton, FEXO exoskeleton and Conventional therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteItaly
Study dates
25 Jan 2022to 31 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 10Show fewer
  • 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 locations and contacts

1 site in 1 country.

Italy1 site

  • Casa di Cura del Policlinico

    Milan, MI, 20144

Other trials in Italy

About this study

Official title: 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.

Read more

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.

Being tested
AGREE exoskeleton, FEXO exoskeleton, Conventional therapy
Medical subject headings
Stroke, Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AGREE exoskeletonDevice

    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.

  • FEXO exoskeletonDevice

    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.

  • Conventional therapyOther

    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
Study groups in NCT05280431
Study groupRoleWhat they receive
Experimental Group (AGREE)Experimental15 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.
Receives: Device: AGREE exoskeleton
Experimental Group (FEXO)Experimental15 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.
Receives: Device: FEXO exoskeleton
Control Group (Conventional therapy)Other15 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.
Receives: Other: Conventional therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. System Usability Scale (SUS)

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

    Measured: up to 5 weeks

Secondary outcomes (13)

  1. Technology Assessment Methods (TAM)

    TAM is an information systems theory that models how users come to accept and use a technology

    Measured: up to 5 weeks

  2. Virtual Reality Questionnaire (VR)

    VR is used to measure how easy or difficult the virtual reality interface is to use

    Measured: up to 5 weeks

  3. Fugl-Meyer Assessment Scale (FMA-UE)

    FMA-UE assesses sensorimotor status including items assessing upper extremity motion, balance, sensation and range of movement

    Measured: up to 5 weeks

  4. Action Research Arm Test (ARAT)

    ARAT is used to assess upper extremity performance (coordination, dexterity and functioning)

    Measured: up to 5 weeks

  5. Modified Ashworth Scale (MAS)

    MAS is used to muscle quantified spasticity

    Measured: up to 5 weeks

  6. Motricity Index (MI)

    MI is used to grade motor activity in muscles of the upper limb

    Measured: up to 5 weeks

  7. Visual Analogue Scale (VAS)

    VAS is a psychometric response scales used to measure subjective pain

    Measured: up to 5 weeks

  8. 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

    Measured: up to 5 weeks

  9. 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

    Measured: up to 5 weeks

  10. 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

    Measured: up to 5 weeks

  11. 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

    Measured: up to 5 weeks

  12. 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.

    Measured: up to 5 weeks

  13. 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

    Measured: up to 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2022
  2. Study start25 Jan 2022
  3. Primary completion31 Mar 2023
  4. Study completion31 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05280431
Sponsor's protocol ID
PCP_EXOs_
Acronym
PCP_EXOs
Status last verified
Feb 2023
First submitted
10 Feb 2022
Last updated
30 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing AGREE exoskeleton, FEXO exoskeleton and Conventional therapy in people with Stroke and Neurologic Disorder, run by Casa di Cura Privata del Policlinico SpA at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

System Usability Scale (SUS) (time frame: up to 5 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05280431.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.

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