StrokeNCT04191109
BRAIN-CONNECTS: Intensive Rehabilitation Program for Subacute Stroke Patients in an Inpatient Rehabilitation Facility
An observational study of Stroke, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
This is an observational study aiming to describe an intensive rehabilitation program for stroke patients in an inpatient rehabilitation facility, measuring the time and reporting activities performed during the therapy sessions (physiotherapy, occupational and speech language therapy). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Observational study
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 25 Jan 2020to Nov 2022
- 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 85 years
- All sexes
- Adult, Older adult
Study population: Subacute stroke patients involved in an inpatient intensive rehabilitation program
Who may be able to join
- aged 18 or over,
- first-ever intracerebral ischemic or hemorrhagic stroke confirmed by neuroimaging,
- less than 3 weeks of stroke onset,
- moderate-to severe impairment (National Institute of Health Stroke Scale [NIHSS] score between 5 and 13),
- functionally independent prior to stroke (Rankin > 2),
- no major cognitive deficits affecting comprehension (Mini-Mental State Examination >24), (7) ability to understand Spanish and/or Catalan
Who cannot join
- Patients with any other neurological or psychiatric condition will be excluded.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Parc de Salut Mar - Hospital del Mar i de L´Esperança
Barcelona, 08025
Esther Duarte, PhD, +34 933 674 214, Eduarte@parcdesalutmar.cat
Monique Messaggi Sartor, PhD, +34 933 674 214, mosartor@gmail.com
About this study
Official title: Intensive Rehabilitation Program for Subacute Stroke Patients in an Inpatient Rehabilitation Facility: Describing A Protocol Study
This is an observational study aiming to describe an intensive rehabilitation program for stroke patients in an inpatient rehabilitation facility, measuring the time and reporting activities performed during the therapy sessions (physiotherapy, occupational and speech language therapy). Indeed, functional and cognitive outcomes will be reported, and data about feasibility and safety of the rehabilitation program will also be recorded.
Read the detailed description
This is an observational descriptive study that will be performed in an inpatient intensive rehabilitation unit. Stroke patients admitted in our neuro-rehabilitation unit who follow the inclusion criteria, will be invited to participate. The main objective of the study is to register the time spent in different activities during therapy session performed in the intensive rehabilitation program. At the end of each session a sum of the minutes spent in each activity will be performed and at the end of the rehabilitation program the average of time spent in each therapy will be calculated. Indeed, throughout these data the total amount of time spent on rehabilitation (hours and minutes) will be obtained. Secondary objectives are to report changes on functional, cognitive and health status outcomes during different time-frames. This outcomes will be assessed at baseline (admission on neuro-rehabilitation unit), at discharge of rehabilitation unit (average of 30 days after stroke), at 3 months and 6 months after stroke. Safety and Feasibility of the program will also de recorded. Feasibility will be assessed by adherence to the prescribed program, including the register of the following parameters: attendance rate (number of planned sessions attended), training session modification (dose reduction or early termination of the individual session) and reasons for training interruption (2 or more days without training session) as fatigue, dizziness, fever… Safety will be assessed registering any adverse event related to rehab (ie. episodes of falls,..)
- Conditions
- Stroke
- Being tested
- Observational study
- Keywords
- Stroke, Intensive Rehabilitation, Time, Physiotherapy, Occupational Therapy, Speech language therapy
- Medical subject headings
- Stroke, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
This is an observational study in which the amount of therapy performed during the rehabilitation program will be registered.Data regarding feasibility and safety of the program will be also recorded. Indeed, functional, cognitive and quality of life outcomes will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Subacute stroke patients admitted to an inpatient rehabilitation facility. Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Structure and Function: The Fugl-Meyer Assessment-upper limb (FMA-UL) will assess arm impairment. (Fugl-Meyer et al., 1975).
Changes in the measurement of arm impairment. Performance is rated on a three point ordinal scale from 0 to 2, with a maximum score of 66, a higher score indicates minimal or no impairment.
Measured: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
Body Structure and Function: Western Aphasia Bedside (WAB) is used to assess the language function of adults with stroke. (Risser, AH et al, 1985)
Changes on WAB will be used to measure language skills. WAB will be used to assess the linguistic skills (information content, fluency, auditory comprehension, repetition, naming and word finding, reading, and writing) and main nonlinguistic skills (drawing, block design, calculation, and praxis) of adults with aphasia.
Measured: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
Body Structure and Function:Cognitive impairment will be assessed using the Montreal Cognitive Assessment (MoCA) (Nasreddine ZS. et al 2005)
Changes on MOCA will be used to detect the cognitive impairments. MOCA is a brief cognitive screening with high sensitivity and specificity for detecting middle cognitive impairment.
Measured: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
Body Structure and Function: Anxiety and Depression that will be assessed using the Hospital Anxiety Depression scale (HADS) (Aben I et al., 2002).
Changes on psychological distress in stroke patients. HADS consists in in 14 items, which can be divided into two subscales of seven items each: the anxiety subscale (HADS-A) and the depression subscale (HADS-D). The respondent rates each item on a 4-point scale ranging from 0 (absence) - 3 (extreme presence). The total score is out of 42 (21 per subscale).
Measured: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
Body Structure and Function: Apathy will be assessed throughout the Apathy Evaluation Scale. (Marin RS et al. 1993)
Changes on apathy in stroke patients. Thuis is a tool that quantifies and characterise apathy in adult patients. The AES, which uses 18 specific items to quantify apathy within a scoring range of 18 to 72.
Measured: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
Body Structure and Function: Limb strength will assessed using the Motricity Index Motricity Index (MI) (Collin C et al.1990).
Changes on upper and lower limb strength using MI which is an ordinal method of measuring limb strength, this test has 6 items on each side 3 for the arm and 3 for the leg.
Measured: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
Activity Level: Assessment of functional disability in basic activities of daily living will be performed using Barthel Index (BI). (Mahoney FI et al.,1965)
Changes on functional disability of stroke patients using BI, which evaluates 10 basic activities of self-care (feeding, grooming, dressing, toileting, bathing, and continence of bowel and bladder) and mobility (transferring, walking, stair climbing) on a total score from 0 (totally dependent) to 100 (totally independent) functioning.
Measured: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
Activity Level: Disability level will be assessed throughout modified Ranking scale (MRS) (Van Swieten JC et al., 1988, Bonita R et al., 1988)
Change in the disability level after stroke. The MRS is a global outcome rating scale ranging from 0 (no impairment) to 5 (bedridden, incontinent, requiring constant nursing care and attention) and 6 (fatal outcome).
Measured: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
Activity Level: Gait speed on 10m walking test. (Pohl M et al., 2007)
Changes on gait speed will be assessed during a 10 meter walking test
Measured: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
Activity Level: Arm function will assessed using the Action Research Arm Test (ARAT) (Hsieh CL et al., 1998, Lang CE et al., 2006)
Changes on arm function will be reported throughout ARAT, this assessment is divided into four sub tests of grasp, grip, pinch and gross arm movement. Performance on each item is rated on a four-point ordinal scale from 0 to 3 with a maximum score of 57, a higher score indicating a better level of function.
Measured: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
Participation Level will be assessed throughout the Stroke Impact Scale (SIS). (Richardson M et al., 2016, Duncan PW et al., 1999)
Changes on Health related quality of life will be assessed throughout SIS , that is a 59-item measurement, which assess 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking and participation level). Each item is rated in a 5 point likert scale in terms of difficulty the patient has experienced in completing each item. Summative scores are generated for each domain, scores ranges from 0-100
Measured: At 3 months and 6 months after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start25 Jan 2020
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Responsible party
- Principal investigator, Esther Duarte, Parc de Salut Mar
- Investigators
- Esther Duarte, PhD, Principal investigator, Parc de Salut Mar - Hospital del Mar i de L´Esperança
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191109
- Sponsor's protocol ID
- 34/C/2017- BRAIN-CONNECTS
- Status last verified
- Sep 2020
- First submitted
- 29 Oct 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sartor MM, Grau-Sanchez J, Guillen-Sola A, Boza R, Puig J, Stinear C, Morgado-Perez A, Duarte E. Intensive rehabilitation programme for patients with subacute stroke in an inpatient rehabilitation facility: describing a protocol of a prospective cohort study. BMJ Open. 2021 Oct 18;11(10):e046346. doi: 10.1136/bmjopen-2020-046346.
PubMed 34663650
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Rehabilitation Program for Subacute Stroke Patients in an Inpatient Rehabilitation Facility: Describing A Protocol Study
- ClinicalTrials.gov ID
- NCT04191109
- Acronym / sponsor ID
- 34/C/2017- BRAIN-CONNECTS
- Conditions
- Stroke
- Keywords
- Stroke, Intensive Rehabilitation, Time, Physiotherapy, Occupational Therapy, Speech language therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Study start
- 25 Jan 2020 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 9 Dec 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.
This is an observational study aiming to describe an intensive rehabilitation program for stroke patients in an inpatient rehabilitation facility, measuring the time and reporting activities performed during the therapy sessions (physiotherapy, occupational and speech language therapy). Indeed, functional and cognitive outcomes will be reported, and data about feasibility and safety of the rehabilitation program will also be recorded.
Detailed description
This is an observational descriptive study that will be performed in an inpatient intensive rehabilitation unit. Stroke patients admitted in our neuro-rehabilitation unit who follow the inclusion criteria, will be invited to participate. The main objective of the study is to register the time spent in different activities during therapy session performed in the intensive rehabilitation program. At the end of each session a sum of the minutes spent in each activity will be performed and at the end of the rehabilitation program the average of time spent in each therapy will be calculated. Indeed, throughout these data the total amount of time spent on rehabilitation (hours and minutes) will be obtained. Secondary objectives are to report changes on functional, cognitive and health status outcomes during different time-frames. This outcomes will be assessed at baseline (admission on neuro-rehabilitation unit), at discharge of rehabilitation unit (average of 30 days after stroke), at 3 months and 6 months after stroke. Safety and Feasibility of the program will also de recorded. Feasibility will be assessed by adherence to the prescribed program, including the register of the following parameters: attendance rate (number of planned sessions attended), training session modification (dose reduction or early termination of the individual session) and reasons for training interruption (2 or more days without training session) as fatigue, dizziness, fever… Safety will be assessed registering any adverse event related to rehab (ie. episodes of falls,..)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Observational studySubacute stroke patients admitted to an inpatient rehabilitation facility. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subacute stroke patients involved in an inpatient intensive rehabilitation program
Key inclusion criteria (6 listed)
- aged 18 or over,
- first-ever intracerebral ischemic or hemorrhagic stroke confirmed by neuroimaging,
- less than 3 weeks of stroke onset,
- moderate-to severe impairment (National Institute of Health Stroke Scale [NIHSS] score between 5 and 13),
- functionally independent prior to stroke (Rankin > 2),
Key exclusion criteria (1 listed)
- Patients with any other neurological or psychiatric condition will be excluded.
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 |
|---|---|---|
| Observational studyThis is an observational study in which the amount of therapy performed during the rehabilitation program will be registered.Data regarding feasibility and safety of the program will be also recorded. Indeed, functional, cognitive and quality of life outcomes will be assessed. | Other | 1 |
Primary outcome
Body Structure and Function: The Fugl-Meyer Assessment-upper limb (FMA-UL) will assess arm impairment. (Fugl-Meyer et al., 1975).
Time frame: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
Changes in the measurement of arm impairment. Performance is rated on a three point ordinal scale from 0 to 2, with a maximum score of 66, a higher score indicates minimal or no impairment.
Body Structure and Function: Western Aphasia Bedside (WAB) is used to assess the language function of adults with stroke. (Risser, AH et al, 1985)
Time frame: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
Changes on WAB will be used to measure language skills. WAB will be used to assess the linguistic skills (information content, fluency, auditory comprehension, repetition, naming and word finding, reading, and writing) and main nonlinguistic skills (drawing, block design, calculation, and praxis) of adults with aphasia.
Body Structure and Function:Cognitive impairment will be assessed using the Montreal Cognitive Assessment (MoCA) (Nasreddine ZS. et al 2005)
Time frame: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
Changes on MOCA will be used to detect the cognitive impairments. MOCA is a brief cognitive screening with high sensitivity and specificity for detecting middle cognitive impairment.
Body Structure and Function: Anxiety and Depression that will be assessed using the Hospital Anxiety Depression scale (HADS) (Aben I et al., 2002).
Time frame: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
Changes on psychological distress in stroke patients. HADS consists in in 14 items, which can be divided into two subscales of seven items each: the anxiety subscale (HADS-A) and the depression subscale (HADS-D). The respondent rates each item on a 4-point scale ranging from 0 (absence) - 3 (extreme presence). The total score is out of 42 (21 per subscale).
Body Structure and Function: Apathy will be assessed throughout the Apathy Evaluation Scale. (Marin RS et al. 1993)
Time frame: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
Changes on apathy in stroke patients. Thuis is a tool that quantifies and characterise apathy in adult patients. The AES, which uses 18 specific items to quantify apathy within a scoring range of 18 to 72.
Body Structure and Function: Limb strength will assessed using the Motricity Index Motricity Index (MI) (Collin C et al.1990).
Time frame: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
Changes on upper and lower limb strength using MI which is an ordinal method of measuring limb strength, this test has 6 items on each side 3 for the arm and 3 for the leg.
Activity Level: Assessment of functional disability in basic activities of daily living will be performed using Barthel Index (BI). (Mahoney FI et al.,1965)
Time frame: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
Changes on functional disability of stroke patients using BI, which evaluates 10 basic activities of self-care (feeding, grooming, dressing, toileting, bathing, and continence of bowel and bladder) and mobility (transferring, walking, stair climbing) on a total score from 0 (totally dependent) to 100 (totally independent) functioning.
Activity Level: Disability level will be assessed throughout modified Ranking scale (MRS) (Van Swieten JC et al., 1988, Bonita R et al., 1988)
Time frame: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
Change in the disability level after stroke. The MRS is a global outcome rating scale ranging from 0 (no impairment) to 5 (bedridden, incontinent, requiring constant nursing care and attention) and 6 (fatal outcome).
Activity Level: Gait speed on 10m walking test. (Pohl M et al., 2007)
Time frame: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
Changes on gait speed will be assessed during a 10 meter walking test
Activity Level: Arm function will assessed using the Action Research Arm Test (ARAT) (Hsieh CL et al., 1998, Lang CE et al., 2006)
Time frame: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
Changes on arm function will be reported throughout ARAT, this assessment is divided into four sub tests of grasp, grip, pinch and gross arm movement. Performance on each item is rated on a four-point ordinal scale from 0 to 3 with a maximum score of 57, a higher score indicating a better level of function.
Participation Level will be assessed throughout the Stroke Impact Scale (SIS). (Richardson M et al., 2016, Duncan PW et al., 1999)
Time frame: At 3 months and 6 months after stroke
Changes on Health related quality of life will be assessed throughout SIS , that is a 59-item measurement, which assess 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking and participation level). Each item is rated in a 5 point likert scale in terms of difficulty the patient has experienced in completing each item. Summative scores are generated for each domain, scores ranges from 0-100
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Derived from this study: PubMed 34663650Sartor MM, Grau-Sanchez J, Guillen-Sola A, Boza R, Puig J, Stinear C, Morgado-Perez A, Duarte E. Intensive rehabilitation programme for patients with subacute stroke in an inpatient rehabilitation facility: describing a protocol of a prospective cohort study. BMJ Open. 2021 Oct 18;11(10):e046346. doi: 10.1136/bmjopen-2020-046346.
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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.
Esther Duarte, PhD principal investigator
Parc de Salut Mar - Hospital del Mar i de L´Esperança
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, run by Parc de Salut Mar at 1 site in Spain.
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 6 inclusion and 1 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 16 Sep 2020. 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 Spain. 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 Esther Duarte, PhD (+34 933 674 214, Eduarte@parcdesalutmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Structure and Function: The Fugl-Meyer Assessment-upper limb (FMA-UL) will assess arm impairment. (Fugl-Meyer et al., 1975). (time frame: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke). The study lists 11 primary outcomes in all. 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 NCT04191109, which also lists 1 linked publication.
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 16 Sep 2020.