Stroke RehabilitationPSRNCT03866057
Post Stroke Intensive Rehabilitation
An observational study of Stroke Rehabilitation, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
Prospective observational cohort study, with 6 months follow up, to identify clinical, instrumental and genetic predictors of functional recovery in hospitalized patients undergoing intensive rehabilitation after stroke. All patients will be evaluated with a standardized protocol. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke Rehabilitation
- How many people
- 270 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2019to 31 Dec 2020
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutively recruited all patients hospitalized in 4 intensive rehabilitative Structures of Don Gnocchi Foundation (IRCCS Firenze, Massa, Fivizzano, La Spezia). Is estimated to recruit a sample of 270 patients (approximately 90 in Florence, 90 in Spezia and 90 in Massa and Fivizzano). Sampling will be performed on presentation, including in the study all the subjects that meet the inclusion criteria listed above. For the sub-project Markers Neurophysiological it is planned to recruit all the patients involved in the general project related to Florence and La Spezia (estimate: 180). For the epigenetic subproject we estimate to involve all the patients recruited in the general project related to Florence (estimate: 90).
Who may be able to join
- age 18-90
- acute ischemic or hemorrhagic stroke (within 30 days)
- consent to participate and to anonymous processing of data.
- Additional inclusion criteria for Sub-project Neurophysiological Markers:
- -signing of informed consent for the participation in the sub-project.
- Additional inclusion criteria for Epigenetic subproject:
- -signing of informed consent for participation in the subproject.
Who cannot join
- -Stroke occurred more than 30 days after the transfer to intensive rehabilitation
- Additional exclusion criteria for Epigenetic subproject (for retrospective analysis):
- history of major psychiatric disorder or recent exacerbation
- global aphasia
- refusal of the patient to participate in the study.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione don Gnocchi
Florence, 50143
Francesca Cecchi, Physician, 05573931, fcecchi@dongnocchi.it
About this study
Official title: Post Stroke Intensive Rehabilitation: Predictors of Outcome and Response to Specific Interventions
Prospective observational cohort study, with 6 months follow up, to identify clinical, instrumental and genetic predictors of functional recovery in hospitalized patients undergoing intensive rehabilitation after stroke. All patients will be evaluated with a standardized protocol. Functional recovery will be assessed at the discharge and after a period of 6 months.
Read the detailed description
Despite progress in the treatment of cerebrovascular diseases in the acute phase, stroke remains a catastrophic event with important public health implications. Post-acute intensive rehabilitation is recommended in patients with neurological deficits, but standardized evaluation protocols are essential for evaluate the efficacy of rehabilitation and for the early identification of prognostic factors of recovery. The search for biomarkers of response to specific treatments aimed to customizing the intervention. Recent studies highlight the importance of neurophysiological markers as predictors of post-stroke epilepsy onset and prognosis. Also genetic substrate and epigenetic mechanisms have a prognostic role; the latter may be modified by the administration of Selective Serotonin Reuptake Inhibitor (SSRI) drugs, largely prescribed according to guidelines in post-stroke depression, confirming the neurotrophic role of these drugs postulated in many studies but never demonstrated in vivo in humans. Specific physiotherapeutic interventions also seem to stimulate optimal functional recovery and brain neuroplasticity, in particular those based on the intensive repetition of tasks, such as robotics and Mirror Therapy. Given that the mechanisms of neuronal plasticity activated by these interventions are presumably different, it is hypothesizable that there are specific predictors of response for each of them.
The primary endpoint of this study is to identify clinical, instrumental and genetic predictors of functional recovery in hospitalized patients undergoing intensive rehabilitation after stroke, evaluated with standardized protocol. Recovery will be assessed at discharge and at follow-up after 6 months.
Secondary endpoints are:
- evaluate the development of post-stroke epilepsy according to the presence of early clinical seizures or electroencephalographic (EEG) anomalies identified at admission to rehabilitation;
- demonstrate in vivo the activation of neuroplasticity by serotonin reuptake inhibitors drugs;
- evaluate in patients with hemiplegia / hemiparesis of upper limb undergoing Mirror Therapy, robotic rehabilitation and traditional physiotherapy, the presence of specific factors predictive of functional recovery, and of response to different treatments.
- Conditions
- Stroke Rehabilitation
- Keywords
- Stroke, Predictors of recovery, Neurological Rehabilitation, Genetic, Epigenetic, Mirror Therapy, Neurophysiopathology
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 study group | All patients hospitalized in 4 intensive rehabilitation Structures of Don Gnocchi Foundation during the enrollment period, suffering from acute (within 30 days) ischemic or emorragic stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Modified Barthel Index (mBI)
Functional recovery; Score from 0 to 100; higher values represent a better outcome.
Measured: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Secondary outcomes (12)
change in Modified Rankin score
Functional recovery; Score from 0 to 6; higher values represent a worse outcome.
Measured: Admission: Time 0; Discharge,up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
change in Fugl Meyer Assessment (FMA)
Sensomotor recovery; Total score from 0 to 64, Upper-limb subscale 0-36; lower-limb subscale 0-28. Higher values represent a better outcome.
Measured: Admission: Time 0; Discharge,up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
change in communication ability (Scala di disabilità comunicativa -SDC)
Communication recovery; Score from 0 to 4; higher values represent a better outcome.
Measured: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
change in Oxford Cognitive Score (OCS)
The Oxford Cognitive Screen (OCS) describes the cognitive deficits after stroke.The scale consists of 10 tasks encompassing five cognitive domains: attention and executive function, language, memory, number processing, and praxis.
Measured: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
change in Hospital Anxiety and Depression Scale (HADS)
depression and anxiety; Score from 0 to 21, subitems Depression and Anxiety. Higher values represent a worse outcome.
Measured: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
change in Functional Ambulation Classification (FAC)
Walking recovery; Score from 0 to 5. Higher values represent a better outcome.
Measured: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
change in Trunk Control Test (TCT)
Trunk control recovery; Score from 0 to 100;Higher values represent a better outcome.
Measured: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
change in Numeric Rating Score (NRS) -Pain
Pain assessment; Score from 0 to 10; Higher values represent a worse outcome.
Measured: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
change in Ashworth spasticity scale
Spasticity; Score from 0 to 4; Higher values represent a worse outcome.
Measured: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
change in National Institute of Health Stroke Scale (NIHSS)
clinical recovery; 15 items scored from 3 to 4 ( total score from 0 to 42). Higher values represent a worse outcome.
Measured: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Post Stroke Epilepsy
We will report possible post stroke seizures.
Measured: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
change in serum Brain Derived Neurotrophic factor (BDNF) epigenetic profile
Neural plasticity
Measured: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start1 Mar 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Stroke RehabilitationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Cecchi, Fondazione Don Carlo Gnocchi ETS
- Investigators
- Francesca Cecchi, Physician, Principal investigator, IRCCS Don Carlo Gnocchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866057
- Sponsor's protocol ID
- FDG_STROKE
- Acronym
- PSR
- Status last verified
- May 2019
- First submitted
- 24 Feb 2019
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alcantara CC, Garcia-Salazar LF, Silva-Couto MA, Santos GL, Reisman DS, Russo TL. Post-stroke BDNF Concentration Changes Following Physical Exercise: A Systematic Review. Front Neurol. 2018 Aug 28;9:637. doi: 10.3389/fneur.2018.00637. eCollection 2018.
PubMed 30210424Balkaya M, Cho S. Genetics of stroke recovery: BDNF val66met polymorphism in stroke recovery and its interaction with aging. Neurobiol Dis. 2019 Jun;126:36-46. doi: 10.1016/j.nbd.2018.08.009. Epub 2018 Aug 15.
PubMed 30118755Bernhardt J, Hayward KS, Kwakkel G, Ward NS, Wolf SL, Borschmann K, Krakauer JW, Boyd LA, Carmichael ST, Corbett D, Cramer SC. Agreed Definitions and a Shared Vision for New Standards in Stroke Recovery Research: The Stroke Recovery and Rehabilitation Roundtable Taskforce. Neurorehabil Neural Repair. 2017 Sep;31(9):793-799. doi: 10.1177/1545968317732668.
PubMed 28934920Boyd LA, Hayward KS, Ward NS, Stinear CM, Rosso C, Fisher RJ, Carter AR, Leff AP, Copland DA, Carey LM, Cohen LG, Basso DM, Maguire JM, Cramer SC. Biomarkers of Stroke Recovery: Consensus-Based Core Recommendations from the Stroke Recovery and Rehabilitation Roundtable. Neurorehabil Neural Repair. 2017 Oct-Nov;31(10-11):864-876. doi: 10.1177/1545968317732680.
PubMed 29233071Caleo M. Rehabilitation and plasticity following stroke: Insights from rodent models. Neuroscience. 2015 Dec 17;311:180-94. doi: 10.1016/j.neuroscience.2015.10.029. Epub 2015 Oct 19.
PubMed 264938586. Cecchi F, Diverio M, Corbella E, del Zotto E, Marrazzo F, Speranza G, Gabrielli MA, Macchi C, Ricca M, Aprile A. Sviluppo di un protocollo condiviso di Fondazione don Gnocchi (FdG) per la Riabilitazione dello Stroke e sua implementazione in 2 Strutture FdG: Studio Pilota. SIMFER Settembre 2018
Connell LA, Smith MC, Byblow WD, Stinear CM. Implementing biomarkers to predict motor recovery after stroke. NeuroRehabilitation. 2018;43(1):41-50. doi: 10.3233/NRE-172395.
PubMed 30056436Di Pino G, Pellegrino G, Assenza G, Capone F, Ferreri F, Formica D, Ranieri F, Tombini M, Ziemann U, Rothwell JC, Di Lazzaro V. Modulation of brain plasticity in stroke: a novel model for neurorehabilitation. Nat Rev Neurol. 2014 Oct;10(10):597-608. doi: 10.1038/nrneurol.2014.162. Epub 2014 Sep 9.
PubMed 25201238Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson L, Truelsen T, O'Donnell M, Venketasubramanian N, Barker-Collo S, Lawes CM, Wang W, Shinohara Y, Witt E, Ezzati M, Naghavi M, Murray C; Global Burden of Diseases, Injuries, and Risk Factors Study 2010 (GBD 2010) and the GBD Stroke Experts Group. Global and regional burden of stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014 Jan 18;383(9913):245-54. doi: 10.1016/s0140-6736(13)61953-4.
PubMed 24449944Habegger S, Wiest R, Weder BJ, Mordasini P, Gralla J, Hani L, Jung S, Reyes M, McKinley R. Relating Acute Lesion Loads to Chronic Outcome in Ischemic Stroke-An Exploratory Comparison of Mismatch Patterns and Predictive Modeling. Front Neurol. 2018 Sep 11;9:737. doi: 10.3389/fneur.2018.00737. eCollection 2018.
PubMed 30254601Kabboord AD, van Eijk M, Fiocco M, van Balen R, Achterberg WP. Assessment of Comorbidity Burden and its Association With Functional Rehabilitation Outcome After Stroke or Hip Fracture: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2016 Nov 1;17(11):1066.e13-1066.e21. doi: 10.1016/j.jamda.2016.07.028. Epub 2016 Sep 20.
PubMed 27663529Kwakkel G, Lannin NA, Borschmann K, English C, Ali M, Churilov L, Saposnik G, Winstein C, van Wegen EEH, Wolf SL, Krakauer JW, Bernhardt J. Standardized Measurement of Sensorimotor Recovery in Stroke Trials: Consensus-Based Core Recommendations from the Stroke Recovery and Rehabilitation Roundtable. Neurorehabil Neural Repair. 2017 Sep;31(9):784-792. doi: 10.1177/1545968317732662.
PubMed 28934918Kim JM, Stewart R, Park MS, Kang HJ, Kim SW, Shin IS, Kim HR, Shin MG, Cho KH, Yoon JS. Associations of BDNF genotype and promoter methylation with acute and long-term stroke outcomes in an East Asian cohort. PLoS One. 2012;7(12):e51280. doi: 10.1371/journal.pone.0051280. Epub 2012 Dec 11.
PubMed 23240009Kim JM, Stewart R, Bae KY, Kim SW, Kang HJ, Shin IS, Kim JT, Park MS, Kim MK, Park SW, Kim YH, Kim JK, Cho KH, Yoon JS. Serotonergic and BDNF genes and risk of depression after stroke. J Affect Disord. 2012 Feb;136(3):833-40. doi: 10.1016/j.jad.2011.09.029. Epub 2011 Oct 20.
PubMed 22014446Kwakkel 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
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Stroke Intensive Rehabilitation: Predictors of Outcome and Response to Specific Interventions
- ClinicalTrials.gov ID
- NCT03866057
- Acronym / sponsor ID
- PSR / FDG_STROKE
- Conditions
- Stroke Rehabilitation
- Keywords
- Stroke, Predictors of recovery, Neurological Rehabilitation, Genetic, Epigenetic, Mirror Therapy, Neurophysiopathology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 7 Mar 2019 (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.
Prospective observational cohort study, with 6 months follow up, to identify clinical, instrumental and genetic predictors of functional recovery in hospitalized patients undergoing intensive rehabilitation after stroke. All patients will be evaluated with a standardized protocol. Functional recovery will be assessed at the discharge and after a period of 6 months.
Detailed description
Despite progress in the treatment of cerebrovascular diseases in the acute phase, stroke remains a catastrophic event with important public health implications. Post-acute intensive rehabilitation is recommended in patients with neurological deficits, but standardized evaluation protocols are essential for evaluate the efficacy of rehabilitation and for the early identification of prognostic factors of recovery. The search for biomarkers of response to specific treatments aimed to customizing the intervention. Recent studies highlight the importance of neurophysiological markers as predictors of post-stroke epilepsy onset and prognosis. Also genetic substrate and epigenetic mechanisms have a prognostic role; the latter may be modified by the administration of Selective Serotonin Reuptake Inhibitor (SSRI) drugs, largely prescribed according to guidelines in post-stroke depression, confirming the neurotrophic role of these drugs postulated in many studies but never demonstrated in vivo in humans. Specific physiotherapeutic interventions also seem to stimulate optimal functional recovery and brain neuroplasticity, in particular those based on the intensive repetition of tasks, such as robotics and Mirror Therapy. Given that the mechanisms of neuronal plasticity activated by these interventions are presumably different, it is hypothesizable that there are specific predictors of response for each of them.
The primary endpoint of this study is to identify clinical, instrumental and genetic predictors of functional recovery in hospitalized patients undergoing intensive rehabilitation after stroke, evaluated with standardized protocol. Recovery will be assessed at discharge and at follow-up after 6 months.
Secondary endpoints are:
- evaluate the development of post-stroke epilepsy according to the presence of early clinical seizures or electroencephalographic (EEG) anomalies identified at admission to rehabilitation;
- demonstrate in vivo the activation of neuroplasticity by serotonin reuptake inhibitors drugs;
- evaluate in patients with hemiplegia / hemiparesis of upper limb undergoing Mirror Therapy, robotic rehabilitation and traditional physiotherapy, the presence of specific factors predictive of functional recovery, and of response to different treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 study group | – | –All patients hospitalized in 4 intensive rehabilitation Structures of Don Gnocchi Foundation during the enrollment period, suffering from acute (within 30 days) ischemic or emorragic stroke |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutively recruited all patients hospitalized in 4 intensive rehabilitative Structures of Don Gnocchi Foundation (IRCCS Firenze, Massa, Fivizzano, La Spezia). Is estimated to recruit a sample of 270 patients (approximately 90 in Florence, 90 in Spezia and 90 in Massa and Fivizzano). Sampling will be performed on presentation, including in the study all the subjects that meet the inclusion criteria listed above. For the sub-project Markers Neurophysiological it is planned to recruit all the patients involved in the general project related to Florence and La Spezia (estimate: 180). For the epigenetic subproject we estimate to involve all the patients recruited in the general project related to Florence (estimate: 90).
Key inclusion criteria (7 listed)
- age 18-90
- acute ischemic or hemorrhagic stroke (within 30 days)
- consent to participate and to anonymous processing of data.
- -signing of informed consent for the participation in the sub-project.
- -signing of informed consent for participation in the subproject.
Key exclusion criteria (5 listed)
- -Stroke occurred more than 30 days after the transfer to intensive rehabilitation
- history of major psychiatric disorder or recent exacerbation
- global aphasia
- refusal of the patient to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in Modified Barthel Index (mBI)
Time frame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Functional recovery; Score from 0 to 100; higher values represent a better outcome.
12 secondary outcomes
change in Modified Rankin score
Time frame: Admission: Time 0; Discharge,up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
change in Fugl Meyer Assessment (FMA)
Time frame: Admission: Time 0; Discharge,up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
change in communication ability (Scala di disabilità comunicativa -SDC)
Time frame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
change in Oxford Cognitive Score (OCS)
Time frame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
change in Hospital Anxiety and Depression Scale (HADS)
Time frame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
change in Functional Ambulation Classification (FAC)
Time frame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
change in Trunk Control Test (TCT)
Time frame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
change in Numeric Rating Score (NRS) -Pain
Time frame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
change in Ashworth spasticity scale
Time frame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
change in National Institute of Health Stroke Scale (NIHSS)
Time frame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Post Stroke Epilepsy
Time frame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
change in serum Brain Derived Neurotrophic factor (BDNF) epigenetic profile
Time frame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Background: PubMed 30210424Alcantara CC, Garcia-Salazar LF, Silva-Couto MA, Santos GL, Reisman DS, Russo TL. Post-stroke BDNF Concentration Changes Following Physical Exercise: A Systematic Review. Front Neurol. 2018 Aug 28;9:637. doi: 10.3389/fneur.2018.00637. eCollection 2018.
- Background: PubMed 30118755Balkaya M, Cho S. Genetics of stroke recovery: BDNF val66met polymorphism in stroke recovery and its interaction with aging. Neurobiol Dis. 2019 Jun;126:36-46. doi: 10.1016/j.nbd.2018.08.009. Epub 2018 Aug 15.
- Background: PubMed 28934920Bernhardt J, Hayward KS, Kwakkel G, Ward NS, Wolf SL, Borschmann K, Krakauer JW, Boyd LA, Carmichael ST, Corbett D, Cramer SC. Agreed Definitions and a Shared Vision for New Standards in Stroke Recovery Research: The Stroke Recovery and Rehabilitation Roundtable Taskforce. Neurorehabil Neural Repair. 2017 Sep;31(9):793-799. doi: 10.1177/1545968317732668.
- Background: PubMed 29233071Boyd LA, Hayward KS, Ward NS, Stinear CM, Rosso C, Fisher RJ, Carter AR, Leff AP, Copland DA, Carey LM, Cohen LG, Basso DM, Maguire JM, Cramer SC. Biomarkers of Stroke Recovery: Consensus-Based Core Recommendations from the Stroke Recovery and Rehabilitation Roundtable. Neurorehabil Neural Repair. 2017 Oct-Nov;31(10-11):864-876. doi: 10.1177/1545968317732680.
- Background: PubMed 26493858Caleo M. Rehabilitation and plasticity following stroke: Insights from rodent models. Neuroscience. 2015 Dec 17;311:180-94. doi: 10.1016/j.neuroscience.2015.10.029. Epub 2015 Oct 19.
- Background6. Cecchi F, Diverio M, Corbella E, del Zotto E, Marrazzo F, Speranza G, Gabrielli MA, Macchi C, Ricca M, Aprile A. Sviluppo di un protocollo condiviso di Fondazione don Gnocchi (FdG) per la Riabilitazione dello Stroke e sua implementazione in 2 Strutture FdG: Studio Pilota. SIMFER Settembre 2018
- Background: PubMed 30056436Connell LA, Smith MC, Byblow WD, Stinear CM. Implementing biomarkers to predict motor recovery after stroke. NeuroRehabilitation. 2018;43(1):41-50. doi: 10.3233/NRE-172395.
- Background: PubMed 25201238Di Pino G, Pellegrino G, Assenza G, Capone F, Ferreri F, Formica D, Ranieri F, Tombini M, Ziemann U, Rothwell JC, Di Lazzaro V. Modulation of brain plasticity in stroke: a novel model for neurorehabilitation. Nat Rev Neurol. 2014 Oct;10(10):597-608. doi: 10.1038/nrneurol.2014.162. Epub 2014 Sep 9.
- Background: PubMed 24449944Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson L, Truelsen T, O'Donnell M, Venketasubramanian N, Barker-Collo S, Lawes CM, Wang W, Shinohara Y, Witt E, Ezzati M, Naghavi M, Murray C; Global Burden of Diseases, Injuries, and Risk Factors Study 2010 (GBD 2010) and the GBD Stroke Experts Group. Global and regional burden of stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014 Jan 18;383(9913):245-54. doi: 10.1016/s0140-6736(13)61953-4.
- Background: PubMed 30254601Habegger S, Wiest R, Weder BJ, Mordasini P, Gralla J, Hani L, Jung S, Reyes M, McKinley R. Relating Acute Lesion Loads to Chronic Outcome in Ischemic Stroke-An Exploratory Comparison of Mismatch Patterns and Predictive Modeling. Front Neurol. 2018 Sep 11;9:737. doi: 10.3389/fneur.2018.00737. eCollection 2018.
- Background: PubMed 27663529Kabboord AD, van Eijk M, Fiocco M, van Balen R, Achterberg WP. Assessment of Comorbidity Burden and its Association With Functional Rehabilitation Outcome After Stroke or Hip Fracture: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2016 Nov 1;17(11):1066.e13-1066.e21. doi: 10.1016/j.jamda.2016.07.028. Epub 2016 Sep 20.
- Background: PubMed 28934918Kwakkel G, Lannin NA, Borschmann K, English C, Ali M, Churilov L, Saposnik G, Winstein C, van Wegen EEH, Wolf SL, Krakauer JW, Bernhardt J. Standardized Measurement of Sensorimotor Recovery in Stroke Trials: Consensus-Based Core Recommendations from the Stroke Recovery and Rehabilitation Roundtable. Neurorehabil Neural Repair. 2017 Sep;31(9):784-792. doi: 10.1177/1545968317732662.
- Individual participant dataSharing planned: No
Related trials for Stroke Rehabilitation
Active, not recruiting
Comparative Effects of Vestibular Rehabilitation With and Without Cervical JPS Training in Stroke Patients
Stroke
Not yet recruiting
Implementation Study on Hospital-to-home Advanced Rehabilitation Technologies (ART)
Brain Injuries
Not yet recruitingObservational study
Neurological Rehabilitation and Neuroplasticity After Ischemic Stroke
Ischemic Stroke, Stroke Rehabilitaion
Recruiting
Effect of an Electromagnetic Trainer on Gait and Balance Recovery After Stroke
Stroke
Not yet recruiting
Beren Vibration Insole in Stroke Rehabilitation
Stroke
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.
Francesca Cecchi, Physician principal investigator
IRCCS Don Carlo Gnocchi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke Rehabilitation, run by Fondazione Don Carlo Gnocchi ETS 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 7 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: status not confirmed, as of the sponsor's last update on 24 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesca Cecchi, Physician (05573931, fcecchi@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Modified Barthel Index (mBI) (time frame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2). 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 NCT03866057, which also lists 25 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 24 May 2019.