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

September 27, 2023 updated by: Marco Franceschini, MD, IRCCS San Raffaele Roma

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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;
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group (EG)
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.
Device: Exoskeleton-Assisted Upper Limb Rehabilitation

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).

Other Names:
  • Armro Power
Active Comparator: Control Group (CG)
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.
Other: Traditional Upper Limb Rehabilitation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fugl-Meyer Assessment of Upper Extremities motor recovery after stroke -FMA
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).
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
Change in Modified Ashworth Scale (shoulder, elbow, and wrist).
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).

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

  1. 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
  2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
  3. Considerable increase in muscle tone, passive movement difficult
  4. Affected part(s) rigid in flexion or extension
Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).
Change in Box & Block Test
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).
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.
Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).
Change in Nine Hole Peg Test
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).

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

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

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

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.

  1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
  2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  3. - Moderate disability. Requires some help, but able to walk unassisted.
  4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  6. - Dead.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Instrumental assessment through the Armeo Power
Time Frame: Session 1 (Baseline-day1, T0) and session 25 (end of treatment-day 35, T1)

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.
Session 1 (Baseline-day1, T0) and session 25 (end of treatment-day 35, T1)
Changes in muscles activity Surface electromyography (sEMG)
Time Frame: Session 1 (Baseline-day1, T0) and session 25 (end of treatment-day 35, T1)
In a subgroup of subjects in EG, changes in muscle activity will be assessed by Surface electromyography (sEMG).
Session 1 (Baseline-day1, T0) and session 25 (end of treatment-day 35, T1)
Kinematic changes
Time Frame: Session 1 (Baseline-day1, T0) and session 25 (end of treatment-day 35, T1)
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.
Session 1 (Baseline-day1, T0) and session 25 (end of treatment-day 35, T1)
Neurophysiological changes through EEG
Time Frame: Session 1 (Baseline-day1, T0) and session 25 (end of treatment-day 35, T1)
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.
Session 1 (Baseline-day1, T0) and session 25 (end of treatment-day 35, T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele Roma

Collaborators

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

Investigators

  • Principal Investigator: Marco Franceschini, Prof., IRCCS San Raffaele Pisana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2020

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

December 24, 2024

Study Registration Dates

First Submitted

December 30, 2020

First Submitted That Met QC Criteria

January 4, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP 20/08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study protocol can be found in the publication.

IPD Sharing Time Frame

Actual

IPD Sharing Access Criteria

Open Access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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