StrokePowerUPS-REHABNCT04697368

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

A study testing Exoskeleton-Assisted Upper Limb Rehabilitation and Traditional Upper Limb Rehabilitation in people with Stroke and Upper Extremity Paresis, run by IRCCS San Raffaele Roma at 7 sites 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

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Stroke, Upper Extremity Paresis
What is being tested?: Exoskeleton-Assisted Upper Limb Rehabilitation and Traditional Upper Limb Rehabilitation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 7 sitesItaly
Study dates: 28 Dec 2020to 24 Dec 2025
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;
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.

Who cannot join

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;

Show all 15Show fewer

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).

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Italy7 sites

Villa Bellombra
Bologna
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara
Azienda Ospedaliero Universitaria Ospedali Riuniti
Foggia
IRCCS Centro Neurolesi Bonino Pulejo
Messina
IRCCS San Raffaele Pisana
Roma, 00163
IRCCS fondazione Santa Lucia
Rome
Fondazione "Gli Angeli di Padre Pio"
San Giovanni Rotondo

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Conditions: Stroke, Upper Extremity Paresis
Being tested: Exoskeleton-Assisted Upper Limb Rehabilitation, Traditional Upper Limb Rehabilitation
Keywords: Stroke, Subacute, upper limb, motor function, robot-assisted rehabilitation, Armeo Power, exoskeleton, Fugle-Meyer Assessment
Medical subject headings: Stroke, Paresis

What participants receive

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

Exoskeleton-Assisted Upper Limb RehabilitationDevice
Also called Armro Power
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).
Traditional Upper Limb RehabilitationOther
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.

Study groups in NCT04697368
Study group	Role	What they receive
Experimental Group (EG)	Experimental	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. Receives: Device: Exoskeleton-Assisted Upper Limb Rehabilitation
Control Group (CG)	Active comparator	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. Receives: Other: Traditional Upper Limb Rehabilitation

What is being measured

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

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.
Measured: 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 outcomes (6)

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

Timeline

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

28 Dec 202024 Dec 2025

First posted6 Jan 2021
Study start28 Dec 2020
Primary completion1 Mar 2025
Study completion24 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This study is a multicentre, single-blind (evaluator) randomized controlled trial (RCT).
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04697368
Sponsor's protocol ID: RP 20/08
Acronym: PowerUPS-REHAB
Status last verified: Oct 2026
First submitted: 30 Dec 2020
Last updated: 15 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The study protocol can be found in the publication.

Publications

Tibaek M, Dehlendorff C, Jorgensen HS, Forchhammer HB, Johnsen SP, Kammersgaard LP. Increasing Incidence of Hospitalization for Stroke and Transient Ischemic Attack in Young Adults: A Registry-Based Study. J Am Heart Assoc. 2016 May 11;5(5):e003158. doi: 10.1161/JAHA.115.003158.
PubMed 27169547
Fang MC, Coca Perraillon M, Ghosh K, Cutler DM, Rosen AB. Trends in stroke rates, risk, and outcomes in the United States, 1988 to 2008. Am J Med. 2014 Jul;127(7):608-15. doi: 10.1016/j.amjmed.2014.03.017. Epub 2014 Mar 25.
PubMed 24680794
Khellaf M, Quantin C, d'Athis P, Fassa M, Jooste V, Hervieu M, Giroud M, Bejot Y. Age-period-cohort analysis of stroke incidence in Dijon from 1985 to 2005. Stroke. 2010 Dec;41(12):2762-7. doi: 10.1161/STROKEAHA.110.592147. Epub 2010 Nov 11.
PubMed 21071719
Bejot Y, Delpont B, Giroud M. Rising Stroke Incidence in Young Adults: More Epidemiological Evidence, More Questions to Be Answered. J Am Heart Assoc. 2016 May 11;5(5):e003661. doi: 10.1161/JAHA.116.003661. No abstract available.
PubMed 27169549
Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7.
PubMed 12907818
Nichols-Larsen DS, Clark PC, Zeringue A, Greenspan A, Blanton S. Factors influencing stroke survivors' quality of life during subacute recovery. Stroke. 2005 Jul;36(7):1480-4. doi: 10.1161/01.STR.0000170706.13595.4f. Epub 2005 Jun 9.
PubMed 15947263
Mehrholz J, Pohl M, Platz T, Kugler J, Elsner B. Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2018 Sep 3;9(9):CD006876. doi: 10.1002/14651858.CD006876.pub5.
PubMed 30175845
Sergi F, Krebs HI, Groissier B, Rykman A, Guglielmelli E, Volpe BT, Schaechter JD. Predicting efficacy of robot-aided rehabilitation in chronic stroke patients using an MRI-compatible robotic device. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:7470-3. doi: 10.1109/IEMBS.2011.6091843.
PubMed 22256066
Dodakian L, Sharp KG, See J, Abidi NS, Mai K, Fling BW, Le VH, Cramer SC. Targeted engagement of a dorsal premotor circuit in the treatment of post-stroke paresis. NeuroRehabilitation. 2013;33(1):13-24. doi: 10.3233/NRE-130923.
PubMed 23949026
Ang KK, Chua KS, Phua KS, Wang C, Chin ZY, Kuah CW, Low W, Guan C. A Randomized Controlled Trial of EEG-Based Motor Imagery Brain-Computer Interface Robotic Rehabilitation for Stroke. Clin EEG Neurosci. 2015 Oct;46(4):310-20. doi: 10.1177/1550059414522229. Epub 2014 Apr 21.
PubMed 24756025
Ang KK, Guan C, Phua KS, Wang C, Zhao L, Teo WP, Chen C, Ng YS, Chew E. Facilitating effects of transcranial direct current stimulation on motor imagery brain-computer interface with robotic feedback for stroke rehabilitation. Arch Phys Med Rehabil. 2015 Mar;96(3 Suppl):S79-87. doi: 10.1016/j.apmr.2014.08.008.
PubMed 25721551
Calabro RS, Russo M, Naro A, Milardi D, Balletta T, Leo A, Filoni S, Bramanti P. Who May Benefit From Armeo Power Treatment? A Neurophysiological Approach to Predict Neurorehabilitation Outcomes. PM R. 2016 Oct;8(10):971-978. doi: 10.1016/j.pmrj.2016.02.004. Epub 2016 Feb 20.
PubMed 26902866
Scano A, Chiavenna A, Malosio M, Molinari Tosatti L, Molteni F. Robotic Assistance for Upper Limbs May Induce Slight Changes in Motor Modules Compared With Free Movements in Stroke Survivors: A Cluster-Based Muscle Synergy Analysis. Front Hum Neurosci. 2018 Aug 15;12:290. doi: 10.3389/fnhum.2018.00290. eCollection 2018.
PubMed 30174596
Gandolfi M, Vale N, Dimitrova EK, Mazzoleni S, Battini E, Filippetti M, Picelli A, Santamato A, Gravina M, Saltuari L, Smania N. Effectiveness of Robot-Assisted Upper Limb Training on Spasticity, Function and Muscle Activity in Chronic Stroke Patients Treated With Botulinum Toxin: A Randomized Single-Blinded Controlled Trial. Front Neurol. 2019 Jan 31;10:41. doi: 10.3389/fneur.2019.00041. eCollection 2019.
PubMed 30766508
Corona F, Gervasoni E, Coghe G, Cocco E, Ferrarin M, Pau M, Cattaneo D. Validation of the Arm Profile Score in assessing upper limb functional impairments in people with multiple sclerosis. Clin Biomech (Bristol). 2018 Jan;51:45-50. doi: 10.1016/j.clinbiomech.2017.11.010. Epub 2017 Nov 22.
PubMed 29179033

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Multicenter Study on the Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.
ClinicalTrials.gov ID: NCT04697368
Acronym / sponsor ID: PowerUPS-REHAB / RP 20/08
Conditions: Stroke, Upper Extremity Paresis
Keywords: Stroke, Subacute, upper limb, motor function, robot-assisted rehabilitation, Armeo Power, exoskeleton, Fugle-Meyer Assessment
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: IRCCS San Raffaele RomaUniversity, hospital or other
Collaborators: Università degli Studi di Ferrara, Fondazione Gli Angeli di Padre Pio, 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, Ministry of Health, Italy
Study start: 28 Dec 2020 (actual)
Primary completion: 1 Mar 2025 (actual)
Study completion: 24 Dec 2025 (actual)
First posted: 6 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: This study is a multicentre, single-blind (evaluator) randomized controlled trial (RCT).

Arm	Type	Receives
Experimental Group (EG)	Experimental	Device: Exoskeleton-Assisted Upper Limb RehabilitationThe 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)	Active comparator	Other: Traditional Upper Limb RehabilitationThe 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.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Exoskeleton-Assisted Upper Limb RehabilitationAlso: Armro PowerThe 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).	Device	Experimental Group (EG)
Traditional Upper Limb RehabilitationThe 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.	Other	Control Group (CG)

Primary outcome

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.

6 secondary outcomes

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).
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).
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).
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).
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).
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).

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
Background: PubMed 27169547Tibaek M, Dehlendorff C, Jorgensen HS, Forchhammer HB, Johnsen SP, Kammersgaard LP. Increasing Incidence of Hospitalization for Stroke and Transient Ischemic Attack in Young Adults: A Registry-Based Study. J Am Heart Assoc. 2016 May 11;5(5):e003158. doi: 10.1161/JAHA.115.003158.
Background: PubMed 24680794Fang MC, Coca Perraillon M, Ghosh K, Cutler DM, Rosen AB. Trends in stroke rates, risk, and outcomes in the United States, 1988 to 2008. Am J Med. 2014 Jul;127(7):608-15. doi: 10.1016/j.amjmed.2014.03.017. Epub 2014 Mar 25.
Background: PubMed 21071719Khellaf M, Quantin C, d'Athis P, Fassa M, Jooste V, Hervieu M, Giroud M, Bejot Y. Age-period-cohort analysis of stroke incidence in Dijon from 1985 to 2005. Stroke. 2010 Dec;41(12):2762-7. doi: 10.1161/STROKEAHA.110.592147. Epub 2010 Nov 11.
Background: PubMed 27169549Bejot Y, Delpont B, Giroud M. Rising Stroke Incidence in Young Adults: More Epidemiological Evidence, More Questions to Be Answered. J Am Heart Assoc. 2016 May 11;5(5):e003661. doi: 10.1161/JAHA.116.003661. No abstract available.
Background: PubMed 12907818Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7.
Background: PubMed 15947263Nichols-Larsen DS, Clark PC, Zeringue A, Greenspan A, Blanton S. Factors influencing stroke survivors' quality of life during subacute recovery. Stroke. 2005 Jul;36(7):1480-4. doi: 10.1161/01.STR.0000170706.13595.4f. Epub 2005 Jun 9.
Background: PubMed 30175845Mehrholz J, Pohl M, Platz T, Kugler J, Elsner B. Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2018 Sep 3;9(9):CD006876. doi: 10.1002/14651858.CD006876.pub5.
Background: PubMed 22256066Sergi F, Krebs HI, Groissier B, Rykman A, Guglielmelli E, Volpe BT, Schaechter JD. Predicting efficacy of robot-aided rehabilitation in chronic stroke patients using an MRI-compatible robotic device. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:7470-3. doi: 10.1109/IEMBS.2011.6091843.
Background: PubMed 23949026Dodakian L, Sharp KG, See J, Abidi NS, Mai K, Fling BW, Le VH, Cramer SC. Targeted engagement of a dorsal premotor circuit in the treatment of post-stroke paresis. NeuroRehabilitation. 2013;33(1):13-24. doi: 10.3233/NRE-130923.
Background: PubMed 24756025Ang KK, Chua KS, Phua KS, Wang C, Chin ZY, Kuah CW, Low W, Guan C. A Randomized Controlled Trial of EEG-Based Motor Imagery Brain-Computer Interface Robotic Rehabilitation for Stroke. Clin EEG Neurosci. 2015 Oct;46(4):310-20. doi: 10.1177/1550059414522229. Epub 2014 Apr 21.
Background: PubMed 25721551Ang KK, Guan C, Phua KS, Wang C, Zhao L, Teo WP, Chen C, Ng YS, Chew E. Facilitating effects of transcranial direct current stimulation on motor imagery brain-computer interface with robotic feedback for stroke rehabilitation. Arch Phys Med Rehabil. 2015 Mar;96(3 Suppl):S79-87. doi: 10.1016/j.apmr.2014.08.008.
Background: PubMed 26902866Calabro RS, Russo M, Naro A, Milardi D, Balletta T, Leo A, Filoni S, Bramanti P. Who May Benefit From Armeo Power Treatment? A Neurophysiological Approach to Predict Neurorehabilitation Outcomes. PM R. 2016 Oct;8(10):971-978. doi: 10.1016/j.pmrj.2016.02.004. Epub 2016 Feb 20.
Individual participant dataSharing planned: Yes. The study protocol can be found in the publication.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marco Franceschini, Prof. principal investigator

IRCCS San Raffaele Pisana

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 15 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 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

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).). 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 NCT04697368, which also lists 18 linked publications.

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 15 Oct 2026.