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The Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke. (PowerUPS-REHAB)

Primary Purpose

Stroke, Upper Extremity Paresis

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Exoskeleton-Assisted Upper Limb Rehabilitation

Traditional Upper Limb Rehabilitation

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Subacute, upper limb, motor function, robot-assisted rehabilitation, Armeo Power, exoskeleton, Fugle-Meyer Assessment

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age between 18 and 85 years;
first stroke with neurological outcomes affecting the upper limb;
patients with severe or moderate hemiparesis (FM-UL≤44), stratified according to severe (FM-UL ≤ 22) or moderate (22 <FM-UL ≤ 44) motor deficit;
patients in the sub-acute phase within 90 days of the acute event, stratified by the distance from the acute event (OAI≤30; OAI> 30);
Modified Ashworth Scale (MAS) of the main components (shoulder, elbow, and wrist) of the upper limb <3;
sufficient cognitive and linguistic level to understand the instructions and provide consent;
signed informed consent.

Exclusion Criteria:

unstable general clinical conditions;
severe visual impairment;
inability to maintain the sitting position;
mild motor deficit of the arm (FM-UL> 44) at baseline;
recent botox injection in the upper limb or planned botox injection during the study period, including the follow-up;
inability to don the orthosis on the impaired upper limb;
bone instability in relevant areas of the upper extremity (unconsolidated fractures, fractures due to osteoporosis);
fixed contractures involving the impaired upper limb (e.g. frozen shoulder);
shoulder instability;
severe pain syndromes caused or intensified by rehabilitation with Armeo Power;
patients who need isolation for infectious diseases ;
epileptic disorder with frequent attacks that carry the risk of having a seizure during rehabilitation with Armeo Power;
history of physical or neurological conditions that interfere with study procedures or assessment of motor function;
interruption of treatment for 1 week, or 5 consecutive sessions;
participation in other innovative treatment protocols for the upper limb rehabilitation (e.g. robotics, virtual reality, AOT ... etc).

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group (EG)

Control Group (CG)

Arm Description

The experimental group (EG), in addition to the standard treatment, will perform one session per day, each lasting 40 minutes, with the Armeo Power robotic system for upper limb rehabilitation. Each subject will perform a total of 25 ± 3 treatment sessions with a frequency of 5 times a week for 5 weeks.

The control group (CG), in addition to the standard routine rehabilitation treatment, will follow 40 minutes of conventional upper limb rehabilitation. Each subject will perform a total of 25 ± 3 conventional upper limb treatment sessions with a frequency of 5 times a week for 5 weeks.

Outcomes

Primary Outcome Measures

Change in Fugl-Meyer Assessment of Upper Extremities motor recovery after stroke -FMA

The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation, and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. In this study, we will consider the motor performance items of Upper extremity (0-66), only.

Secondary Outcome Measures

Change in Modified Ashworth Scale (shoulder, elbow, and wrist).

The Modified Ashworth scale (MAS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Scoring (taken from Bohannon and Smith, 1987): 0: No increase in muscle tone Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved Considerable increase in muscle tone, passive movement difficult Affected part(s) rigid in flexion or extension

Change in Box & Block Test

The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple, and inexpensive test. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. The box should be oriented lengthwise and placed at the client's midline, with the compartment holding the blocks oriented towards the hand being tested. In order to practice and register baseline scores, the test should begin with the unaffected upper limb. Additionally, a 15-second trial period is permitted at the beginning of each side. Before the trial, after the standardized instructions are given to clients, they should be advised that their fingertips must cross the partition when transferring the blocks and that they do not need to pick up the blocks that might fall outside of the box.

Change in Nine Hole Peg Test

The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses. Description: Administered by asking the client to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible; Scores are based on the time taken to complete the test activity, recorded in seconds; Alternative scoring - the number of pegs placed in 50 or 100 seconds can be recorded. In this case, results are expressed as the number of pegs placed per second; Stopwatch should be started from the moment the participant touches the first peg until the moment the last peg hits the container.

Change in Frenchy Arm Test

The Frenchay Arm Test (FAT) is a measure of upper extremity proximal motor control and dexterity during ADL performance in patients with impairments resulting from neurological conditions. The FAT is an upper extremity specific measure of activity limitation. Each item is scored as either pass (=1) or fail (=0). Total scores range from 0 to 5.

Change in modified Barthel Index

The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge. Time is taken and physical assistance required to perform each item is used in determining the assigned value of each item. The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self-care ADL (consisting in: feeding, personal hygiene, bathing, dressing, chair-bed transfer, toileting, bladder continence, bowel continence, ambulation, or wheelchair use, and stair climbing.). Scoring (Pellicciari et al, 2020): The item scores are summed across them in order to compute the total score; a score of 0 indicates total assistance, while a total score of 100 indicates total independence. T

Change in Modified Rankin scale

The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It has become the most widely used clinical outcome measure for stroke clinical trials. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead.

Full Information

NCT ID

NCT04697368

First Posted

December 30, 2020

Last Updated

September 27, 2023

Sponsor

IRCCS San Raffaele Roma

Collaborators

Università degli Studi di Ferrara, Fondazione Gli Angeli di Padre Pio, Habilita S.p.A., Azienda Ospedaliero, Universitaria Ospedali Riuniti, IRCCS Centro Neurolesi "Bonino-Pulejo", I.R.C.C.S. Fondazione Santa Lucia, Presidio Ospedaliero Accreditato Villa Bellombra S.p.A

1. Study Identification

Unique Protocol Identification Number

NCT04697368

Brief Title

The Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.

Acronym

PowerUPS-REHAB

Official Title

A Randomized Controlled Multicenter Study on the Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 24, 2020 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IRCCS San Raffaele Roma

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Loss of arm function is a common and distressing consequence of stroke. Neurotechnology-aided rehabilitation could be a promising approach to accelerate the recovery of upper limb functional impairments. This multicentre randomized controlled trial is aimed at assessing the efficacy of robot-assisted upper limb rehabilitation in subjects with sub-acute stroke following a stroke, compared to the traditional upper limb rehabilitation.

Detailed Description

Stroke is the most common cause of complex adult disability in high-income countries [1]. Loss of arm function affects 69% of people who have a stroke [2]. Only 12% of people with arm weakness at the onset of stroke make a full recovery [3]. Improving arm function has been identified as a research priority by stroke survivors, carers, and health professionals who report that current rehabilitation pays insufficient attention to arm recovery [4]. Robot-assisted training enables a greater number of repetitive tasks to be practiced in a consistent and controllable manner. Repetitive task training is known to drive Hebbian plasticity, where the wiring of pathways that are coincidently active is strengthened [5, 6]. A dose of greater than 20 h of repetitive task training improves upper limb motor recovery following a stroke [7] and, therefore, robot-assisted training has the potential to improve arm motor recovery after stroke. We anticipate that Hebbian neuroplasticity, which is learning dependent, will operate regardless of the post-stroke phase. We, hereby, describe the protocol for a multicentre randomized controlled trial to determine whether robot-assisted training improves upper limb function following a stroke in the sub-acute stage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Upper Extremity Paresis

Keywords

Stroke, Subacute, upper limb, motor function, robot-assisted rehabilitation, Armeo Power, exoskeleton, Fugle-Meyer Assessment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This study is a multicentre, single-blind (evaluator) randomized controlled trial (RCT).

Masking

Outcomes Assessor

Masking Description

The outcome assessor will be blind to the study protocol.

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental Group (EG)

Arm Type

Experimental

Arm Description

Arm Title

Control Group (CG)

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Exoskeleton-Assisted Upper Limb Rehabilitation

Other Intervention Name(s)

Armro Power

Intervention Description

The patients will be undergone 25+/-3 Armeo-P training sessions, each lasting 40 minutes (i.e. five times a week for five consecutive weeks). During the first session, the device should be adjusted to the patient's arm size and the angle of suspension. The working space and the exercises will be selected once the UL has been fitted with the system. The selection of personalized exercises will be based on the motor skills of each patient and the difficulty can be gradually increased during training. In particular, a course of exercises has been defined in which the difficulty (suspension rate; the level of assistance; the complexity of movement (1D, 2D, 3D)). The physiotherapist will choose the modality based on the patient's motor skills (standardized personalized training).

Intervention Type

Other

Intervention Name(s)

Traditional Upper Limb Rehabilitation

Intervention Description

The control group (CG), in addition to the conventional treatment based on the routine rehabilitation program, will follow 25+/-3 sessions of traditional upper limb rehabilitation (i.e. five times a week for five consecutive weeks). Each session will consist of passive, active-assisted, and active exercises addressed for shoulder, arm and hand motor rehabilitation.

Primary Outcome Measure Information:

Title

Change in Fugl-Meyer Assessment of Upper Extremities motor recovery after stroke -FMA

Description

Time Frame

Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).

Secondary Outcome Measure Information:

Title

Change in Modified Ashworth Scale (shoulder, elbow, and wrist).

Description

Time Frame

Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).

Title

Change in Box & Block Test

Description

Time Frame

Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).

Title

Change in Nine Hole Peg Test

Description

Time Frame

Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).

Title

Change in Frenchy Arm Test

Description

Time Frame

Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).

Title

Change in modified Barthel Index

Description

Time Frame

Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).

Title

Change in Modified Rankin scale

Description

Time Frame

Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).

Other Pre-specified Outcome Measures:

Title

Instrumental assessment through the Armeo Power

Description

Subjects in EG will be assessed also through the Armeo power: A_FORCE: measure of the force exerted by the patient for each movement; A_MOVE: measures the patient's 3D work area (paint the walls of the room); A-GOAL: movement functionality.

Time Frame

Session 1 (Baseline-day1, T0) and session 25 (end of treatment-day 35, T1)

Title

Changes in muscles activity Surface electromyography (sEMG)

Description

In a subgroup of subjects in EG, changes in muscle activity will be assessed by Surface electromyography (sEMG).

Time Frame

Session 1 (Baseline-day1, T0) and session 25 (end of treatment-day 35, T1)

Title

Kinematic changes

Description

In a subgroup of subjects in EG, kinematic changes will be assessed by the movement analysis using the RAB protocol with the stereophotogrammetric system or inertial sensors.

Time Frame

Session 1 (Baseline-day1, T0) and session 25 (end of treatment-day 35, T1)

Title

Neurophysiological changes through EEG

Description

In a subgroup of subjects in EG, the cerebral electrical activity will be recorded by EEG (0.3-100 Hz bandpass, sampling frequency: 512 Hz) from 32 up to 128 electrodes positioned according to the International System 10-20 increased during rest conditions: closed and open eyes(3 minutes each). To monitor eye movements, horizontal and vertical electroculogram (0.3-70 Hz bandpass) will be recorded. The delta (2-4 Hz), theta (4-8 Hz), alpha1 (8-10.5 Hz), alpha2 (10.5-13 Hz), beta1 (13-20 Hz), beta2 (20-30Hz) and gamma (30-40Hz) frequency bands will be analyzed. The EEG data will be normalized and the activation current density of the cortical sources on 6239 voxels will be calculated using standardized Low-Resolution Electromagnetic Tomography (sLORETA). Cerebral Connectivity will be calculated with the eLORETA on 84 regions on the basis of the 42 Brodmann areas (right and left hemispheres). Through the 84 regions of interest of eLORETA, the Lagged Linear Coherence will be calculated.

Time Frame

Session 1 (Baseline-day1, T0) and session 25 (end of treatment-day 35, T1)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age between 18 and 85 years; first stroke with neurological outcomes affecting the upper limb; patients with severe or moderate hemiparesis (FM-UL≤44), stratified according to severe (FM-UL ≤ 22) or moderate (22 <FM-UL ≤ 44) motor deficit; patients in the sub-acute phase within 90 days of the acute event, stratified by the distance from the acute event (OAI≤30; OAI> 30); Modified Ashworth Scale (MAS) of the main components (shoulder, elbow, and wrist) of the upper limb <3; sufficient cognitive and linguistic level to understand the instructions and provide consent; signed informed consent. Exclusion Criteria: unstable general clinical conditions; severe visual impairment; inability to maintain the sitting position; mild motor deficit of the arm (FM-UL> 44) at baseline; recent botox injection in the upper limb or planned botox injection during the study period, including the follow-up; inability to don the orthosis on the impaired upper limb; bone instability in relevant areas of the upper extremity (unconsolidated fractures, fractures due to osteoporosis); fixed contractures involving the impaired upper limb (e.g. frozen shoulder); shoulder instability; severe pain syndromes caused or intensified by rehabilitation with Armeo Power; patients who need isolation for infectious diseases ; epileptic disorder with frequent attacks that carry the risk of having a seizure during rehabilitation with Armeo Power; history of physical or neurological conditions that interfere with study procedures or assessment of motor function; interruption of treatment for 1 week, or 5 consecutive sessions; participation in other innovative treatment protocols for the upper limb rehabilitation (e.g. robotics, virtual reality, AOT ... etc).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sanaz Pournajaf, Dr.

Phone

+39-065225

Ext

22319

sanaz.pournajaf@sanraffaele.it

First Name & Middle Initial & Last Name or Official Title & Degree

Michela Goffredo, Ing.

michela.goffredo@sanraffaele.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marco Franceschini, Prof.

Organizational Affiliation

IRCCS San Raffaele Pisana

Official's Role

Principal Investigator

Facility Information:

Facility Name

HABILITA S.p.A

City

Bergamo

State/Province

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michelangelo Bartolo, Dr

bartolomichelangelo@gmail.com

Facility Name

Villa Bellombra

City

Bologna

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Rosaria Leo, Dr.

Mrosaria.leo@villabellombra.it

First Name & Middle Initial & Last Name & Degree

Claudia Zanetti, Dr.

Claudia.Zanetti@villabellombra.it

Facility Name

Azienda Ospedaliero-Universitaria di Ferrara

City

Ferrara

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sofia Straudi, Dr.

sofia.straudi@gmail.com

Facility Name

Azienda Ospedaliero Universitaria Ospedali Riuniti

City

Foggia

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrea Santamato, Prof.

andrea.santamato@unifg.it

First Name & Middle Initial & Last Name & Degree

Salvatore Facciarusso, Dr.

s.facciorusso89@gmail.com

Facility Name

IRCCS Centro Neurolesi Bonino Pulejo

City

Messina

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vincenzo Cimino, Dr.

vincenzo.cimino@irccsme.it

Facility Name

IRCCS San Raffaele Pisana

City

Roma

ZIP/Postal Code

00163

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Astrid Van Rijn

Phone

+39-065225

Ext

23405

astrid.vanrijn@sanraffaele.it

First Name & Middle Initial & Last Name & Degree

Sanaz Pournajaf, Dr.

Phone

+39-065225

Ext

22319

sanaz.pournajaf@sanraffaele.it

First Name & Middle Initial & Last Name & Degree

Sanaz Pournajaf, Dr.

Facility Name

IRCCS fondazione Santa Lucia

City

Rome

Country

Italy

Individual Site Status

Active, not recruiting

Facility Name

Fondazione "Gli Angeli di Padre Pio"

City

San Giovanni Rotondo

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Serena Filoni, Dr.

dsangeli@centripadrepio.it

First Name & Middle Initial & Last Name & Degree

Emanuele Russo, Ing.

sic@centripadrepio.it

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The study protocol can be found in the publication.

IPD Sharing Time Frame

Actual

IPD Sharing Access Criteria

Open Access

IPD Sharing URL

https://pubmed.ncbi.nlm.nih.gov/37190665/

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The Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.

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The Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke. (PowerUPS-REHAB)

Stroke, Upper Extremity Paresis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial