Analysis of Functional Capacity in People With Stroke After an Educational Intervention

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Malaga
ClinicalTrials.gov Identifier:
NCT01980641
First received: October 14, 2013
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

AIM: Improve functional capacity in people with Stroke by a multimodal intervention DESIGN: Randomized controlled trial SUBJECTS OF THE STUDY: People with Stroke INTERVENTION: DATA ANALYSIS: descriptive statistics, measuring central tendency and dispersion of the variables study. Inferential statistics will be made between intervention of key variables and outcome


Condition Intervention
Stroke
Behavioral: Educational intervention
Device: Smartphone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Analysis of Functional Capacity in People With Stroke After Condition-specific Home Exercises Combined With Advice and Education

Further study details as provided by University of Malaga:

Primary Outcome Measures:
  • Barthel Index [ Time Frame: Changes from Baseline to 8; 18 and 28 weeks ] [ Designated as safety issue: Yes ]

    The 10-item Barthel Index was published in 1965 as a simple index of functional independence, particularly in personal and domestic activities of daily living. This instrument consists of 10 items on activities of daily living (grooming, dressing, bathing, and bowel and bladder status), each with 2 or 4 response categories (0-3 points).Total score range from 0 to 100.

    Houlden H, Edwards M, McNeil J, Greenwood R. Use of the Barthel Index and the Functional Independence Measure during early inpatient rehabilitation after single incident brain injury. Clin Rehabil. 2006 Feb;20(2):153-9.

    Grauwmeijer E, Heijenbrok-Kal MH, Haitsma IK, Ribbers GM. A prospective study on employment outcome 3 years after moderate to severe traumatic brain injury. Arch Phys Med Rehabil. 2012 Jun;93(6):993-9.

    Collin C, Wade DT, Davies S, Horne V. The Barthel ADL Index: a reliability study. Int Disabil Stud. 1988;10(2):61-3.



Secondary Outcome Measures:
  • Canadian Neurological Scale [ Time Frame: Change from Baseline to 8, 18 and 28 weeks ] [ Designated as safety issue: Yes ]

    Provides a standardized neurological assessment of cognitive and motor function in stroke patients (alert or drowsy). Used to assess alertness in stroke patients. Includes the following assessments: Level of consciousness, Orientation, Aphasia and Motor strength. Assessments of motor function are separated into two sections: A1: administered if patient is able to understand and follow instructions, and A2: administered in the presence of comprehension deficits.

    Rehab Measures - Canadian Neurological Scale [Internet]. Rehabil. Meas. Database. [cited 2013 Oct 13]. Available from: http://www.rehabmeasures.org/Lists/RehabMeasures/DispForm.aspx?ID=906


  • Stroke impact scale-16 [ Time Frame: Changes from Baseline; 8; 18 and 28 weeks ] [ Designated as safety issue: Yes ]

    Assesses health status following stroke. The SIS-16 is a short version os SIS 3.0 and it consists of 16 items capturing daily activities. Total score range from 16 to 80.

    Rehab Measures - Stroke Impact Scale [Internet]. Rehabil. Meas. Database. [cited 2013 Oct 13]. Available from: http://www.rehabmeasures.org/Lists/RehabMeasures/DispForm.aspx?ID=934


  • Mini-Mental State Examination [ Time Frame: Changes from Baseline; 8; 18 and 28 weeks ] [ Designated as safety issue: Yes ]

    A brief screening tool to provide a quantitative assessment of cognitive impairment and to record cognitive changes over time. The MMSE consists of 11 simple questions or tasks grouped into 7 cognitive domains. Levels of impairment have been classified as (Tombaugh & McIntyre 1992): None: score = 24-30; Mild: score = 18-24 and Severe: score = 0-17.

    Rehab Measures - Mini-Mental State Examination [Internet]. Rehabil. Meas. Database. [cited 2013 Oct 13]. Available from: http://www.rehabmeasures.org/Lists/RehabMeasures/DispForm.aspx?ID=912


  • Functional Independence Measure [ Time Frame: Changes from Baseline; 8; 18 and 28 weeks ] [ Designated as safety issue: Yes ]

    Provides a uniform system of measurement for disability based on the International Classification of Impairment, Disabilities and Handicaps; measures the level of a patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living. Contains 18 items composed of 13 motor tasks and 5 cognitive tasks (considered basic activities of daily living. Tasks are rated on a 7 point ordinal scale that ranges from total assistance (or complete dependence) to complete independence.

    Desrosiers J, Rochette A, Noreau L, Bravo G, Hébert R, Boutin C. Comparison of two functional independence scales with a participation measure in post-stroke rehabilitation. Arch Gerontol Geriatr. 2003 Sep;37(2):157-72.

    Houlden H, Edwards M, McNeil J, Greenwood R. Use of the Barthel Index and the Functional Independence Measure during early inpatient rehabilitation after single incident brain injury. Clin Rehabil. 2006 Feb;20(2):153-9.


  • Trunk Control Test [ Time Frame: Baseline; 8; 18 and 28 weeks ] [ Designated as safety issue: Yes ]

    TCT measures four simple aspects of trunk movement. 4 items (rolling to weak side, rolling to strong side, balance in sitting position, sit up from lying down). Total score range: 0 (minimum) to 100 (maximum, indicating better performance).

    Rehab Measures - Trunk Control Test [Internet]. Rehabil. Meas. Database. [cited 2013 Oct 14]. Available from: http://www.rehabmeasures.org/Lists/RehabMeasures/DispForm.aspx?ID=1058


  • Modified Rankin Handicap Scale [ Time Frame: Baseline; 8; 18 and 28 weeks ] [ Designated as safety issue: Yes ]

    MRHS categorizes level of functional independence with reference to pre-stroke activities. Assessment is carried out by asking the patient about their activities of daily living, including outdoor activities. Information about the patient's neurological deficits on examination, including aphasia and intellectual deficits, should be obtained.

    Rehab Measures - Modified Rankin Handicap Scale [Internet]. Rehabil. Meas. Database. [cited 2013 Oct 13]. Available from: http://www.rehabmeasures.org/Lists/RehabMeasures/DispForm.aspx?ID=921


  • Escala de Apoyo Social Percibido [ Time Frame: Baseline; 8; 18 and 28 weeks ] [ Designated as safety issue: Yes ]

    EASP consist in 12 items about social support in four groups: family, friends and other significant people. The range of score fro each item is from 1 to 7.

    Arechabala Mantuliz MC, Miranda Castillo c. Validación de una escala de apoyo social percibido en un grupo de adultos mayores adscritos a un programa de hipertensión de la región metropolitana. Cienc Enfermería. 2002 Jun;8(1):49-55.


  • Escala de Calidad de Vida para el Ictus [ Time Frame: Baseline; 8; 18 and 28 weeks ] [ Designated as safety issue: Yes ]

    ECVI-38 consist of 38 items grouped in 8 domains. This instrument measure the quiality of life after stroke. Each item is scored from 1 to 5.

    Concepción OF, Pérez ER, Alvarez MA, Zuaznábar MAB. Validación de la escala de calidad de vida para el ictus (ECVI-38). Rev Neurol. 2008;46(3):147-52.


  • Functional Reach test [ Time Frame: Baseline; 8; 18 and 28 weeks ] [ Designated as safety issue: Yes ]

    Assesses a patient's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position. Scores are determined by assessing the difference between the start and end position is the reach distance, usually measured in inches.

    Rehab Measures - Functional Reach Test / Modified Functional... [Internet]. Rehabil. Meas. Database. [cited 2013 Oct 13]. Available from: http://www.rehabmeasures.org/Lists/RehabMeasures/DispForm.aspx?ID=950&Source=http%3A%2F%2Fwww%2Erehabmeasures%2Eorg%2Frehabweb%2Fallmeasures%2Easpx%3FPageView%3DShared


  • Romberg Test [ Time Frame: Baseline; 8; 18 and 28 weeks ] [ Designated as safety issue: Yes ]

    RT measure the balance. Romberg stance with open and closed eyes, and a one-legged stance.

    Juul-Kristensen B, Clausen B, Ris I, Jensen R, Steffensen R, Chreiteh S, et al. Increased neck muscle activity and impaired balance among females with whiplash-related chronic neck pain: A cross-sectional study. J Rehabil Med. 2013;45(4):376-84.


  • Time Up and Go [ Time Frame: Baseline; 8; 18 and 28 weeks ] [ Designated as safety issue: Yes ]

    Assesses mobility, balance, walking ability, and fall risk in older adults. The patient sits in the chair with his/her back against the chair back. On the command "go", the patient rises from the chair, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down.

    Rehab Measures - Timed Up and Go [Internet]. Rehabil. Meas. Database. [cited 2013 Oct 13]. Available from: http://www.rehabmeasures.org/Lists/RehabMeasures/DispForm.aspx?ID=903


  • Strength testing with a portable dynamometer [ Time Frame: Baseline; 8; 18 and 28 weeks ] [ Designated as safety issue: Yes ]
    The portable dynamometer is reliable for testing upper extremity muscle groups. Agre JC, Magness JL, Hull SZ, Wright KC, Baxter TL, Patterson R, et al. Strength testing with a portable dynamometer: reliability for upper and lower extremities. Arch Phys Med Rehabil. 1987 Jul;68(7):454-8.

  • Timed-stands test [ Time Frame: Baseline; 8; 18 and 28 weeks ] [ Designated as safety issue: Yes ]

    TST measures the of lower body strength. The TST provides a reasonably reliable and valid indicator of lower body strength in generally active, community-dwelling older adults.

    Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9.



Enrollment: 40
Study Start Date: July 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control group
Follow up detraining effect of multimodal intervention
Behavioral: Educational intervention
All subjects received an educational intervention consist in an educational advice provides by the therapist to improve the adherence of the treatment.
Experimental: Application smartphone-based group
Smartphone-based application group (SG) sample will have a reminder to do Phisical activity everyday where patients will have to select if they have done or they haven´t done physical activity.
Behavioral: Educational intervention
All subjects received an educational intervention consist in an educational advice provides by the therapist to improve the adherence of the treatment.
Device: Smartphone

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Long-term Stroke (>1 year)
  • A score from 0 to 49 on Barthel Index (moderate/severe stroke)
  • Participant were able to use an Smartphone

Exclusion Criteria:

  • Severe cognitive illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01980641

Locations
Spain
Patronato Municipal de deportes de Torremolinos
Torremolinos, Malaga, Spain, 29620
Sponsors and Collaborators
University of Malaga
Investigators
Principal Investigator: Antonio I Cuesta Vargas, PhD University of Malaga
  More Information

Additional Information:
No publications provided

Responsible Party: University of Malaga
ClinicalTrials.gov Identifier: NCT01980641     History of Changes
Other Study ID Numbers: FCCSS-15-2013
Study First Received: October 14, 2013
Last Updated: November 8, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by University of Malaga:
Stroke
ADL
mHealth
App
Adherence

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 18, 2014