BRAIN-CONNECTS: Intensive Rehabilitation Program for Subacute Stroke Patients in an Inpatient Rehabilitation Facility

Parc de Salut Mar

Status: Unknown

Conditions: Stroke

Treatments: Other: Observational study

Study type: Observational

Funder types: Other

Identifiers

NCT04191109

34/C/2017- BRAIN-CONNECTS

Details and patient eligibility

About

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.

Full 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,..)

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

1

Description:

Subacute stroke patients admitted to an inpatient rehabilitation facility.

Treatment:

Other: Observational study