Chronic StrokeREDIRECTNCT06884553
Robotic Rehabilitation Vs Occupational Therapy Chronic Stroke Upper Limb Rehabilitation
A study testing Robotic therapy (Gloreha Sinfonia system) and Occupational therapy in people with Chronic Stroke, run by University of Florence at 1 site in Italy.
Trial summary
The functional recovery of the upper limb represents a critical element in post-stroke rehabilitation; hemiplegic/hemiparetic patients who achieve optimal recovery are a minority, and incomplete recovery has relevant consequences both on functioning and on quality of life of those who survive a stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Robotic therapy (Gloreha Sinfonia system) and Occupational therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 19 Sep 2023to 19 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First ischemic or hemorrhagic stroke occurring at least 6 months prior.
- Persistent motor deficit in the affected upper limb (Motricity Index between 18 and 77).
- Willingness to participate in the study, with the provision of informed consent.
Who cannot join
- Severe spastic hypertonia at the wrist and fingers (Modified Ashworth Scale equal to or greater than 3).
- Orthopedic, rheumatological, and/or peripheral nervous system disorders affecting the paretic upper limb.
- Neurodegenerative and neuromuscular disorders.
- Acute pathologies affecting other body systems.
- Severe cognitive, language, and behavioral disorders that significantly limit understanding and participation in the planned activities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Don Carlo Gnocchi Onlus
Florence, Italy, 50100
Chiara Castagnoli, PT, 3333738921, ccastagnoli@dongnocchi.it
About this study
Official title: Effects of Robot-assistED Rehabilitation Versus OccupatIonal Therapy on the Functional Recovery of the Upper Limb in PatiEnts with Chronic STroke: a Randomized Controlled Trial
The functional recovery of the upper limb represents a critical element in post-stroke rehabilitation; hemiplegic/hemiparetic patients who achieve optimal recovery are a minority, and incomplete recovery has relevant consequences both on functioning and on quality of life of those who survive a stroke. The project aims to assess the effects on the functional recovery, with manual dexterity as the primary outcome, of a treatment protocol using an innovative tool (Gloreha Sinfonia) that enables assisted execution of three-dimensional tasks combined with Serious Games for cognitive stimulation, targeting the functional recovery of the upper limb in patients with stroke outcomes at least 6 months after the acute event (chronic phase). Patients with residual dysfunction of the upper limb, at least 6 months after the stroke, will be randomly assigned to the Robotic Rehabilitation group (ROBOT), the Occupational Therapy group (OT), focused on the use of the upper limb in functional tasks (task-oriented training), or the control group (CT - prescription of a home exercise program). Patients in the ROBOT and OT groups will undergo a total treatment period of 5 weeks, with 3 sessions per week lasting 1 hour, for a total of 15 sessions/hours of treatment. Patients assigned to the CT group will undergo an initial functional assessment required for defining the exercise program. All patients will be evaluated at baseline (T0), at a 5-week interval (T1), and 6 months after the end of treatment (T2). Outcome indicators include measures of manual dexterity/upper limb performance, anxiety/depression, cognitive abilities, and patient-perceived outcomes. The analysis of Surface Plasmon Resonance imaging (SPRi) of serum exosome content, detected at T0, T1, and T2, will be correlated with variations in functional measures to verify the hypothesis that induction of neuroplasticity underlies any observed changes. Short- and medium-term effects on functional, psychological outcomes, as well as indicators of neuroinflammation and neural regeneration from serum analysis using innovative SPRi, will be compared among the 3 groups.
- Conditions
- Chronic Stroke
- Being tested
- Robotic therapy (Gloreha Sinfonia system), Occupational therapy, Control
- Keywords
- Robotic rehabilitation, occupational therapy, chronic stroke, upper limb impairment, biomarkers, manual dexterity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic therapy (Gloreha Sinfonia system)Device
Group A will receive rehabilitative treatment using the Gloreha Sinfonia system . The treatment regimen spans five weeks and encompasses a progressive series of exercises. Gloreha features an adaptable mechanical design developed for hand rehabilitation. Its activities involve grasping and releasing, facilitated through a lightweight and flexible orthosis. The device, comprising a robotic glove and mechanical arm, enables both finger mobility and upper limb support, facilitating semi-autonomous execution of motor tasks. Gloreha's versatility allows for exercises involving the entire upper limb, including motor-cognitive "serious games" utilizing virtual reality and interaction with real objects. Real-time feedback enhances patient self-assessment. Moreover, the robot incorporates an automated component interfacing with flexion sensors, gauging the patient's autonomous engagement in Occupational Therapy tasks and serious games.
Occupational therapyOther
Occupational Therapy is also recommended in Stroke Rehabilitation Clinical Guidelines. However, its implementation in rehabilitation services in Italy is still limited, presumably due to regulatory factors. For stroke patients, the goal of occupational therapy is to enhance the ability to perform activities of daily living, often focusing on the use of the hand and upper limb in purposeful tasks. Strategies employed by occupational therapists include assessment, treatment, compensation strategies, assistive technologies, and environmental adaptations.
Occupational therapy appears to enhance performance in activities of daily living and reduce the likelihood of impairment in these abilities, although the evidence is of low quality. There is also limited and moderately quality evidence in the area of occupational therapy for addressing depressive and anxiety symptoms in hospital-based rehabilitation for physical disabilities.
ControlBehavioural
Participants will be provided guidance by a skilled physiotherapist to follow a customized exercise regimen independently within the comfort of their homes. This program will specifically target the upper limb and will be tailored according to the evaluation performed at the initial assessment.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Robotic therapy | Experimental | Group A will undergo rehabilitative treatment using Gloreha Sinfonia hand robot, administered by a physical therapist experienced in robotic rehabilitation. The treatment will involve a set of progressively challenging exercises over the course of five weeks (3 sessions per week, each lasting 1 hour). The delivery of the treatment will be conducted in a face-to-face mode. Receives: Device: Robotic therapy (Gloreha Sinfonia system) |
| Group B - Occupational Therapy | Experimental | Group B will attend small group occupational therapy treatment (occupational therapist/patient ratio: 1:4). Subjects will attend a rehabilitative intervention lasting a total of 5 weeks, with three sessions per week, each lasting one hour, for a total of 15 hours of treatment. Receives: Other: Occupational therapy |
| Group C - Control Group | Active comparator | Group C (control group) will receive advice from an experienced physiotherapist for a personalized exercise program to be independently carried out at their own residence. The program will focus on the upper limb and will be based on the assessment conducted at baseline. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual dexterity
Nine Hole Peg Test (Johansson et al., 2019) - MCID=32s (Sivan et al., 2011); MDC =32,8 sec; Percentage Change=54% (Chen et al., 2009)
Measured: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Secondary outcomes (11)
Upper limb motor skills
Wolf Motor Function Test (Wolf et al., 2001) - Minimal Clinically Important Difference (MCID) for Functional Ability: 1.0 points (paretic dominant limb), 1.2 points (paretic non-dominant limb), 17% change (paretic dominant limb), 20% change (paretic non-dominant limb); MCID for Time: -19 seconds, 16% change (paretic dominant limb) (Lang et al., 2008); Minimal Detectable Change (MDC) for timed items: 0.7 seconds; MDC for Functional Ability Scale: 0.1 points (Fritz et al., 2009).
Measured: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Manual dexterity and activities of daily living abilities
ABILHAND questionnaire (Ekstrand et al., 2014) - Minimal Clinically Important Difference (MCID) ranges from 0.26 to 0.35 logits (Wang, 2011).
Measured: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS) (Snaith, 2003) - Minimal Clinically Important Difference (MCID) for Anxiety = 1.96, MCID for Depression = 1.55 (in the context of Cardiovascular Diseases) (Lemay et al., 2018).
Measured: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Cognitive functioning screening
Montreal Cognitive Assessment (MOCA) (Shi et al., 2018) - Minimal Detectable Change (MDC) = 3.94 (90% CI), 4.21 (95% CI) - values for the elderly population and geriatric care (Feeney et al., 2016).
Measured: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Neglect
Hearts Test (Mancuso et al., 2016)
Measured: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Health status and quality of life
Short Form 12 (SF-12) (Gandek et al., 1998) - Minimal Clinically Important Difference (MCID) = 1.8-3.0 units (Fu et al., 2021).
Measured: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Shoulder/elbow/hand pain
Numeric Rating Scale (NRS) (Ferreira-Valente et al., 2011) ranging from 0 (no pain) to 10 (worst possible pain)
Measured: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Participation
Frenchay Activity Index (FAI) (Antonucci et al., 2022)
Measured: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Perceived change
Seven-level Likert scale (much worse, worse, somewhat worse, about the same, somewhat improved, improved, much improved) (Likert, 1932)
Measured: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Treatment satisfaction
NRS 0-10 (Van Berckel et al., 2016)
Measured: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Neuroplasticity
correlation between outcome measures and variations in surface markers of extracellular vesicles (EVs) as a complex biomarker of neuroplasticity, vascular regeneration, and inflammatory response, assessed through Surface Plasmon Resonance imaging (SPRi)
Measured: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start19 Sep 2023
- Primary completion19 Sep 2025 (estimated)
- Study completion19 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Chronic 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 is a multicenter, prospective, randomized controlled trial (RCT) designed for nonprofit purposes and aimed at demonstrating superiority.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Don Carlo Gnocchi ETS
- Responsible party
- Principal investigator, Francesca Cecchi, University of Florence
- Investigators
- Francesca Cecchi, MD, Principal investigator, University of FlorenceChiara Castagnoli, PT, Principal investigator, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884553
- Sponsor's protocol ID
- REDIRECT
- Acronym
- REDIRECT
- Status last verified
- Mar 2025
- First submitted
- 17 Oct 2023
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Antonucci L, Barbato C, Pellicciari L, Paperini A, Hochleitner I, Castagnoli C, Verdesca S, Lucidi G, Marignani S, Pancani S, Basagni B, Macchi C, Cecchi F. Italian translation and cross-cultural validation of an assessment tool for participation in stroke survivors: the Frenchay Activities Index. Neurol Sci. 2022 Jul;43(7):4297-4306. doi: 10.1007/s10072-022-05949-5. Epub 2022 Feb 18.
PubMed 35179673Aprile I, Germanotta M, Cruciani A, Loreti S, Pecchioli C, Cecchi F, Montesano A, Galeri S, Diverio M, Falsini C, Speranza G, Langone E, Papadopoulou D, Padua L, Carrozza MC; FDG Robotic Rehabilitation Group. Upper Limb Robotic Rehabilitation After Stroke: A Multicenter, Randomized Clinical Trial. J Neurol Phys Ther. 2020 Jan;44(1):3-14. doi: 10.1097/NPT.0000000000000295.
PubMed 31834217Bennett DA, Krishnamurthi RV, Barker-Collo S, Forouzanfar MH, Naghavi M, Connor M, Lawes CM, Moran AE, Anderson LM, Roth GA, Mensah GA, Ezzati M, Murray CJ, Feigin VL; Global Burden of Diseases, Injuries, and Risk Factors 2010 Study Stroke Expert Group. The global burden of ischemic stroke: findings of the GBD 2010 study. Glob Heart. 2014 Mar;9(1):107-12. doi: 10.1016/j.gheart.2014.01.001.
PubMed 25432120Bertani R, Melegari C, De Cola MC, Bramanti A, Bramanti P, Calabro RS. Effects of robot-assisted upper limb rehabilitation in stroke patients: a systematic review with meta-analysis. Neurol Sci. 2017 Sep;38(9):1561-1569. doi: 10.1007/s10072-017-2995-5. Epub 2017 May 24.
PubMed 28540536Cecchi F, Cassio A, Lavezzi S, Scarponi F, Gatta G, Montis A, Bernucci C, Franceschini M, Bargellesi S, Paolucci S, Taricco M. Redefining a minimal assessment protocol for stroke rehabilitation: the new "Protocollo di Minima per l'ICtus" (PMIC2020). Eur J Phys Rehabil Med. 2021 Oct;57(5):669-676. doi: 10.23736/S1973-9087.21.06638-7. Epub 2021 May 27.
PubMed 34042407Chen HM, Chen CC, Hsueh IP, Huang SL, Hsieh CL. Test-retest reproducibility and smallest real difference of 5 hand function tests in patients with stroke. Neurorehabil Neural Repair. 2009 Jun;23(5):435-40. doi: 10.1177/1545968308331146. Epub 2009 Mar 4.
PubMed 19261767Chien WT, Chong YY, Tse MK, Chien CW, Cheng HY. Robot-assisted therapy for upper-limb rehabilitation in subacute stroke patients: A systematic review and meta-analysis. Brain Behav. 2020 Aug;10(8):e01742. doi: 10.1002/brb3.1742. Epub 2020 Jun 26.
PubMed 32592282Cooke SF, Bliss TV. Plasticity in the human central nervous system. Brain. 2006 Jul;129(Pt 7):1659-73. doi: 10.1093/brain/awl082. Epub 2006 May 3.
PubMed 16672292Crema A, Bassolino M, Guanziroli E, Colombo M, Blanke O, Serino A, Micera S, Molteni F. Neuromuscular electrical stimulation restores upper limb sensory-motor functions and body representations in chronic stroke survivors. Med. 2022 Jan 14;3(1):58-74.e10. doi: 10.1016/j.medj.2021.12.001. Epub 2022 Jan 7.
PubMed 35590144Dimyan MA, Cohen LG. Neuroplasticity in the context of motor rehabilitation after stroke. Nat Rev Neurol. 2011 Feb;7(2):76-85. doi: 10.1038/nrneurol.2010.200. Epub 2011 Jan 18.
PubMed 21243015Ekstrand E, Lindgren I, Lexell J, Brogardh C. Test-retest reliability of the ABILHAND questionnaire in persons with chronic stroke. PM R. 2014 Apr;6(4):324-31. doi: 10.1016/j.pmrj.2013.09.015. Epub 2013 Oct 7.
PubMed 24113290Feeney J, Savva GM, O'Regan C, King-Kallimanis B, Cronin H, Kenny RA. Measurement Error, Reliability, and Minimum Detectable Change in the Mini-Mental State Examination, Montreal Cognitive Assessment, and Color Trails Test among Community Living Middle-Aged and Older Adults. J Alzheimers Dis. 2016 May 31;53(3):1107-14. doi: 10.3233/JAD-160248.
PubMed 27258421Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
PubMed 21856077Fritz SL, Blanton S, Uswatte G, Taub E, Wolf SL. Minimal detectable change scores for the Wolf Motor Function Test. Neurorehabil Neural Repair. 2009 Sep;23(7):662-7. doi: 10.1177/1545968309335975. Epub 2009 Jun 4.
PubMed 19498013Fu V, Weatherall M, McNaughton H. Estimating the minimal clinically important difference for the Physical Component Summary of the Short Form 36 for patients with stroke. J Int Med Res. 2021 Dec;49(12):3000605211067902. doi: 10.1177/03000605211067902.
PubMed 34939887
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Robot-assistED Rehabilitation Versus OccupatIonal Therapy on the Functional Recovery of the Upper Limb in PatiEnts with Chronic STroke: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06884553
- Acronym / sponsor ID
- REDIRECT / REDIRECT
- Conditions
- Chronic Stroke
- Keywords
- Robotic rehabilitation, occupational therapy, chronic stroke, upper limb impairment, biomarkers, manual dexterity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Collaborators
- Fondazione Don Carlo Gnocchi ETS
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 19 Sep 2025 (estimated)
- Study completion
- 19 Sep 2025 (estimated)
- First posted
- 19 Mar 2025 (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.
The functional recovery of the upper limb represents a critical element in post-stroke rehabilitation; hemiplegic/hemiparetic patients who achieve optimal recovery are a minority, and incomplete recovery has relevant consequences both on functioning and on quality of life of those who survive a stroke. The project aims to assess the effects on the functional recovery, with manual dexterity as the primary outcome, of a treatment protocol using an innovative tool (Gloreha Sinfonia) that enables assisted execution of three-dimensional tasks combined with Serious Games for cognitive stimulation, targeting the functional recovery of the upper limb in patients with stroke outcomes at least 6 months after the acute event (chronic phase). Patients with residual dysfunction of the upper limb, at least 6 months after the stroke, will be randomly assigned to the Robotic Rehabilitation group (ROBOT), the Occupational Therapy group (OT), focused on the use of the upper limb in functional tasks (task-oriented training), or the control group (CT - prescription of a home exercise program). Patients in the ROBOT and OT groups will undergo a total treatment period of 5 weeks, with 3 sessions per week lasting 1 hour, for a total of 15 sessions/hours of treatment. Patients assigned to the CT group will undergo an initial functional assessment required for defining the exercise program. All patients will be evaluated at baseline (T0), at a 5-week interval (T1), and 6 months after the end of treatment (T2). Outcome indicators include measures of manual dexterity/upper limb performance, anxiety/depression, cognitive abilities, and patient-perceived outcomes. The analysis of Surface Plasmon Resonance imaging (SPRi) of serum exosome content, detected at T0, T1, and T2, will be correlated with variations in functional measures to verify the hypothesis that induction of neuroplasticity underlies any observed changes. Short- and medium-term effects on functional, psychological outcomes, as well as indicators of neuroinflammation and neural regeneration from serum analysis using innovative SPRi, will be compared among the 3 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a multicenter, prospective, randomized controlled trial (RCT) designed for nonprofit purposes and aimed at demonstrating superiority.
| Arm | Type | Receives |
|---|---|---|
| Group A - Robotic therapy | Experimental | Device: Robotic therapy (Gloreha Sinfonia system)Group A will undergo rehabilitative treatment using Gloreha Sinfonia hand robot, administered by a physical therapist experienced in robotic rehabilitation. The treatment will involve a set of progressively challenging exercises over the course of five weeks (3 sessions per week, each lasting 1 hour). The delivery of the treatment will be conducted in a face-to-face mode. |
| Group B - Occupational Therapy | Experimental | Other: Occupational therapyGroup B will attend small group occupational therapy treatment (occupational therapist/patient ratio: 1:4). Subjects will attend a rehabilitative intervention lasting a total of 5 weeks, with three sessions per week, each lasting one hour, for a total of 15 hours of treatment. |
| Group C - Control Group | Active comparator | Behavioral: ControlGroup C (control group) will receive advice from an experienced physiotherapist for a personalized exercise program to be independently carried out at their own residence. The program will focus on the upper limb and will be based on the assessment conducted at baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First ischemic or hemorrhagic stroke occurring at least 6 months prior.
- Persistent motor deficit in the affected upper limb (Motricity Index between 18 and 77).
- Willingness to participate in the study, with the provision of informed consent.
Key exclusion criteria (5 listed)
- Severe spastic hypertonia at the wrist and fingers (Modified Ashworth Scale equal to or greater than 3).
- Orthopedic, rheumatological, and/or peripheral nervous system disorders affecting the paretic upper limb.
- Neurodegenerative and neuromuscular disorders.
- Acute pathologies affecting other body systems.
- Severe cognitive, language, and behavioral disorders that significantly limit understanding and participation in the planned activities.
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 |
|---|---|---|
| Robotic therapy (Gloreha Sinfonia system)Group A will receive rehabilitative treatment using the Gloreha Sinfonia system . The treatment regimen spans five weeks and encompasses a progressive series of exercises. Gloreha features an adaptable mechanical design developed for hand rehabilitation. Its activities involve grasping and releasing, facilitated through a lightweight and flexible orthosis. The device, comprising a robotic glove and mechanical arm, enables both finger mobility and upper limb support, facilitating semi-autonomous execution of motor tasks. Gloreha's versatility allows for exercises involving the entire upper limb, including motor-cognitive "serious games" utilizing virtual reality and interaction with real objects. Real-time feedback enhances patient self-assessment. Moreover, the robot incorporates an automated component interfacing with flexion sensors, gauging the patient's autonomous engagement in Occupational Therapy tasks and serious games. | Device | Group A - Robotic therapy |
| Occupational therapyOccupational Therapy is also recommended in Stroke Rehabilitation Clinical Guidelines. However, its implementation in rehabilitation services in Italy is still limited, presumably due to regulatory factors. For stroke patients, the goal of occupational therapy is to enhance the ability to perform activities of daily living, often focusing on the use of the hand and upper limb in purposeful tasks. Strategies employed by occupational therapists include assessment, treatment, compensation strategies, assistive technologies, and environmental adaptations. Occupational therapy appears to enhance performance in activities of daily living and reduce the likelihood of impairment in these abilities, although the evidence is of low quality. There is also limited and moderately quality evidence in the area of occupational therapy for addressing depressive and anxiety symptoms in hospital-based rehabilitation for physical disabilities. | Other | Group B - Occupational Therapy |
| ControlParticipants will be provided guidance by a skilled physiotherapist to follow a customized exercise regimen independently within the comfort of their homes. This program will specifically target the upper limb and will be tailored according to the evaluation performed at the initial assessment. | Behavioural | Group C - Control Group |
Primary outcome
Manual dexterity
Time frame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Nine Hole Peg Test (Johansson et al., 2019) - MCID=32s (Sivan et al., 2011); MDC =32,8 sec; Percentage Change=54% (Chen et al., 2009)
11 secondary outcomes
Upper limb motor skills
Time frame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Manual dexterity and activities of daily living abilities
Time frame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Anxiety and depression
Time frame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Cognitive functioning screening
Time frame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Neglect
Time frame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Health status and quality of life
Time frame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Shoulder/elbow/hand pain
Time frame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Participation
Time frame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Perceived change
Time frame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Treatment satisfaction
Time frame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Neuroplasticity
Time frame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Background: PubMed 35179673Antonucci L, Barbato C, Pellicciari L, Paperini A, Hochleitner I, Castagnoli C, Verdesca S, Lucidi G, Marignani S, Pancani S, Basagni B, Macchi C, Cecchi F. Italian translation and cross-cultural validation of an assessment tool for participation in stroke survivors: the Frenchay Activities Index. Neurol Sci. 2022 Jul;43(7):4297-4306. doi: 10.1007/s10072-022-05949-5. Epub 2022 Feb 18.
- Background: PubMed 31834217Aprile I, Germanotta M, Cruciani A, Loreti S, Pecchioli C, Cecchi F, Montesano A, Galeri S, Diverio M, Falsini C, Speranza G, Langone E, Papadopoulou D, Padua L, Carrozza MC; FDG Robotic Rehabilitation Group. Upper Limb Robotic Rehabilitation After Stroke: A Multicenter, Randomized Clinical Trial. J Neurol Phys Ther. 2020 Jan;44(1):3-14. doi: 10.1097/NPT.0000000000000295.
- Background: PubMed 25432120Bennett DA, Krishnamurthi RV, Barker-Collo S, Forouzanfar MH, Naghavi M, Connor M, Lawes CM, Moran AE, Anderson LM, Roth GA, Mensah GA, Ezzati M, Murray CJ, Feigin VL; Global Burden of Diseases, Injuries, and Risk Factors 2010 Study Stroke Expert Group. The global burden of ischemic stroke: findings of the GBD 2010 study. Glob Heart. 2014 Mar;9(1):107-12. doi: 10.1016/j.gheart.2014.01.001.
- Background: PubMed 28540536Bertani R, Melegari C, De Cola MC, Bramanti A, Bramanti P, Calabro RS. Effects of robot-assisted upper limb rehabilitation in stroke patients: a systematic review with meta-analysis. Neurol Sci. 2017 Sep;38(9):1561-1569. doi: 10.1007/s10072-017-2995-5. Epub 2017 May 24.
- Background: PubMed 34042407Cecchi F, Cassio A, Lavezzi S, Scarponi F, Gatta G, Montis A, Bernucci C, Franceschini M, Bargellesi S, Paolucci S, Taricco M. Redefining a minimal assessment protocol for stroke rehabilitation: the new "Protocollo di Minima per l'ICtus" (PMIC2020). Eur J Phys Rehabil Med. 2021 Oct;57(5):669-676. doi: 10.23736/S1973-9087.21.06638-7. Epub 2021 May 27.
- Background: PubMed 19261767Chen HM, Chen CC, Hsueh IP, Huang SL, Hsieh CL. Test-retest reproducibility and smallest real difference of 5 hand function tests in patients with stroke. Neurorehabil Neural Repair. 2009 Jun;23(5):435-40. doi: 10.1177/1545968308331146. Epub 2009 Mar 4.
- Background: PubMed 32592282Chien WT, Chong YY, Tse MK, Chien CW, Cheng HY. Robot-assisted therapy for upper-limb rehabilitation in subacute stroke patients: A systematic review and meta-analysis. Brain Behav. 2020 Aug;10(8):e01742. doi: 10.1002/brb3.1742. Epub 2020 Jun 26.
- Background: PubMed 16672292Cooke SF, Bliss TV. Plasticity in the human central nervous system. Brain. 2006 Jul;129(Pt 7):1659-73. doi: 10.1093/brain/awl082. Epub 2006 May 3.
- Background: PubMed 35590144Crema A, Bassolino M, Guanziroli E, Colombo M, Blanke O, Serino A, Micera S, Molteni F. Neuromuscular electrical stimulation restores upper limb sensory-motor functions and body representations in chronic stroke survivors. Med. 2022 Jan 14;3(1):58-74.e10. doi: 10.1016/j.medj.2021.12.001. Epub 2022 Jan 7.
- Background: PubMed 21243015Dimyan MA, Cohen LG. Neuroplasticity in the context of motor rehabilitation after stroke. Nat Rev Neurol. 2011 Feb;7(2):76-85. doi: 10.1038/nrneurol.2010.200. Epub 2011 Jan 18.
- Background: PubMed 24113290Ekstrand E, Lindgren I, Lexell J, Brogardh C. Test-retest reliability of the ABILHAND questionnaire in persons with chronic stroke. PM R. 2014 Apr;6(4):324-31. doi: 10.1016/j.pmrj.2013.09.015. Epub 2013 Oct 7.
- Background: PubMed 27258421Feeney J, Savva GM, O'Regan C, King-Kallimanis B, Cronin H, Kenny RA. Measurement Error, Reliability, and Minimum Detectable Change in the Mini-Mental State Examination, Montreal Cognitive Assessment, and Color Trails Test among Community Living Middle-Aged and Older Adults. J Alzheimers Dis. 2016 May 31;53(3):1107-14. doi: 10.3233/JAD-160248.
- Individual participant dataSharing planned: No
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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.
Francesca Cecchi, MD principal investigator
University of Florence
Chiara Castagnoli, PT principal investigator
Fondazione Don Carlo Gnocchi ETS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic therapy (Gloreha Sinfonia system) and Occupational therapy in people with Chronic Stroke, run by University of Florence 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 19 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca Cecchi, MD (3388627184, francesca.cecchi@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manual dexterity (time frame: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (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 NCT06884553, which also lists 48 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 19 Mar 2025.