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

NCT04191109 | Unknown

• 1 other identifier: 34/C/2017- BRAIN-CONNECTS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Intensive Rehabilitation; Time; Physiotherapy; Occupational Therapy; Speech language therapy

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

  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.

  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).

  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.

  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.

  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.

  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).

  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

  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.

  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

  At 3 months and 6 months after stroke

Study Arms (1)

1

Subacute stroke patients admitted to an inpatient rehabilitation facility.

Other: Observational study

Interventions

Observational study OTHER

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.

1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subacute stroke patients involved in an inpatient intensive rehabilitation program

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Parc de Salut Mar: lead
• Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta: collaborator

Study Sites (1)

Parc de Salut Mar - Hospital del Mar i de L´Esperança

Barcelona, 08025, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 34663650 DERIVED

MeSH Terms

Conditions

Stroke; Communication Disorders

Interventions

Observation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Esther Duarte, PhD

  Parc de Salut Mar - Hospital del Mar i de L´Esperança

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esther Duarte, PhD

CONTACT

+34 933 674 214; Eduarte@parcdesalutmar.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Physical Medicine and Rehabilitation Department

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: December 9, 2019
• Study Start: January 25, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

ES (1)