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

Not Applicable

Recruiting

• Conditions: Stroke; Upper Extremity Paresis
• Interventions: Device: Exoskeleton-Assisted Upper Limb Rehabilitation; Other: Traditional Upper Limb Rehabilitation

• Registration Number: NCT04697368
• Lead Sponsor: IRCCS San Raffaele Roma

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.

Study Timeline

• Study Start: 2020-12-28
• Study First Submitted: 2020-12-30
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-06
• Status Verified: 2025-03
• Primary Completion: 2025-03-01
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Study Completion: 2025-12-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group (EG)	Exoskeleton-Assisted Upper Limb Rehabilitation	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.
Control Group (CG)	Traditional Upper Limb Rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
Change in Fugl-Meyer Assessment of Upper Extremities motor recovery after stroke -FMA	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.

Secondary Outcome Measures

Name	Time	Method
Change in Modified Ashworth Scale (shoulder, elbow, and wrist).	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
Change in Box & Block Test	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.
Change in Nine Hole Peg Test	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.
Change in Frenchy Arm Test	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.
Change in modified Barthel Index	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
Change in Modified Rankin scale	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.

Trial Locations

Locations (8)

HABILITA S.p.A; 🇮🇹 Bergamo, BG, Italy

Villa Bellombra; 🇮🇹 Bologna, Italy

Azienda Ospedaliero-Universitaria di Ferrara; 🇮🇹 Ferrara, Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti; 🇮🇹 Foggia, Italy

IRCCS Centro Neurolesi Bonino Pulejo; 🇮🇹 Messina, Italy

IRCCS San Raffaele Pisana; 🇮🇹 Roma, Italy

IRCCS fondazione Santa Lucia; 🇮🇹 Rome, Italy

Fondazione "Gli Angeli di Padre Pio"; 🇮🇹 San Giovanni Rotondo, Italy