Clinical trial NCT04191109: BRAIN-CONNECTS: Intensive Rehabilitation Program for Subacute Stroke Patients in an Inpatient Rehabilitation Facility
Official title: Intensive Rehabilitation Program for Subacute Stroke Patients in an Inpatient Rehabilitation Facility: Describing A Protocol Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: Stroke
Intensive Rehabilitation
Time
Physiotherapy
Occupational Therapy
Speech language therapy
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
First posted: 2019-12-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subacute stroke patients involved in an inpatient intensive rehabilitation program

Brief 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). 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,..)

Eligibility criteria: Inclusion Criteria:

1. aged 18 or over,
2. first-ever intracerebral ischemic or hemorrhagic stroke confirmed by neuroimaging,
3. less than 3 weeks of stroke onset,
4. moderate-to severe impairment (National Institute of Health Stroke Scale \[NIHSS\] score between 5 and 13),
5. functionally independent prior to stroke (Rankin \> 2),
6. no major cognitive deficits affecting comprehension (Mini-Mental State Examination \>24), (7) ability to understand Spanish and/or Catalan

Exclusion Criteria:

* Patients with any other neurological or psychiatric condition will be excluded.

Primary outcomes:
measure: Body Structure and Function: The Fugl-Meyer Assessment-upper limb (FMA-UL) will assess arm impairment. (Fugl-Meyer et al., 1975).
timeFrame: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
measure: Body Structure and Function: Western Aphasia Bedside (WAB) is used to assess the language function of adults with stroke. (Risser, AH et al, 1985)
timeFrame: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
measure: Body Structure and Function:Cognitive impairment will be assessed using the Montreal Cognitive Assessment (MoCA) (Nasreddine ZS. et al 2005)
timeFrame: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
measure: Body Structure and Function: Anxiety and Depression that will be assessed using the Hospital Anxiety Depression scale (HADS) (Aben I et al., 2002).
timeFrame: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
measure: Body Structure and Function: Apathy will be assessed throughout the Apathy Evaluation Scale. (Marin RS et al. 1993)
timeFrame: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
measure: Body Structure and Function: Limb strength will assessed using the Motricity Index Motricity Index (MI) (Collin C et al.1990).
timeFrame: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
measure: Activity Level: Assessment of functional disability in basic activities of daily living will be performed using Barthel Index (BI). (Mahoney FI et al.,1965)
timeFrame: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
measure: Activity Level: Disability level will be assessed throughout modified Ranking scale (MRS) (Van Swieten JC et al., 1988, Bonita R et al., 1988)
timeFrame: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
measure: Activity Level: Gait speed on 10m walking test. (Pohl M et al., 2007)
timeFrame: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
measure: Activity Level: Arm function will assessed using the Action Research Arm Test (ARAT) (Hsieh CL et al., 1998, Lang CE et al., 2006)
timeFrame: Admission on rehabilitation unit - Average 30 days after stroke (discharge of rehabilitation unit) - 3 months and 6 months after stroke
measure: Participation Level will be assessed throughout the Stroke Impact Scale (SIS). (Richardson M et al., 2016, Duncan PW et al., 1999)
timeFrame: At 3 months and 6 months after stroke
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Parc de Salut Mar - Hospital del Mar i de L´Esperança
Study officials:
affiliation: Parc de Salut Mar - Hospital del Mar i de L´Esperança
name: Esther Duarte, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.