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"Core Stability" Exercises to Improve Sitting Balance in Stroke Patients (Fisionet)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01864382
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : September 16, 2014
Sponsor:
Collaborators:
Corporacion Parc Tauli
Institut Investigacio Sanitaria Pere Virgili
Information provided by (Responsible Party):
Rosa Cabanas-Valdes, Universitat Internacional de Catalunya

Tracking Information
First Submitted Date  ICMJE May 21, 2013
First Posted Date  ICMJE May 29, 2013
Last Update Posted Date September 16, 2014
Study Start Date  ICMJE October 2012
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2013)
Dynamic sitting balance [ Time Frame: Baseline, up to 25 sessions and follow up to 24 weeks ]
Trunk Impairment Scales:Is a tool to measure the motor impairment of the trunk after stroke, This scale evaluates dynamic sitting balance as well as co-ordination of trunk movement.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01864382 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2013)
Standing balance [ Time Frame: Baseline, up to 25 sessions and follow up to 24 weeks ]
Berg Balance Scale (BBS)assesses standing balance. This scale includes 14 common tasks of ability to maintain positions or movements of increasing difficulty by decreasing base of support from sit, to stand, to single-limb support.Each of the 14 tasks is scored on a scale from 0 (worst) to 4 (best) for a total score of 56.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 23, 2013)
Mobility and degree of disability [ Time Frame: Baseline, up to 25 sessions and follow up to 24 weeks ]
The Barthel index is a valid scale for studying function in stroke patients.The initial Barthel score is an important prognostic factor for both recovery of function and for survival. The scale consists 10 items.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE "Core Stability" Exercises to Improve Sitting Balance in Stroke Patients
Official Title  ICMJE Effects of the Inclusion of Exercises "Core Stability" in the Treatment of Inpatient Physiotherapy to Improve Balance in Post-stroke Patients Sitting in Subacute Phase. Randomized Clinical Trial.
Brief Summary The stroke as cerebrovascular disease is the leading cause of permanent neurological disability and the third death in the Western world. Their affected often have motor and sensory disturbances in the form of hemiparesis with a possible influence on the balance be altered trunk muscles, important components of postural control. The treatment of stroke, covers a wide range of different strategies and approaches physiotherapy, including, specific exercises on the trunk called "core stability", performed by the patient with the help and supervision of a physiotherapist specializing in neurology, that are based on coordination, motor and proprioceptive work, especially the lumbar-pelvic. The effectiveness of these last years has been demonstrated empirically, but until now there is no sufficient evidence of the effects of these exercises on sitting balance in respect, and standing up in the subacute phase post-stroke patients. To prove the evidence raises a randomized, multicenter, blinded and where the evaluator will not participate in the analysis and processing is done by intention to treat. Patients will be divided into two groups: control (usual physiotherapy center made ) and experimental (made also 15 minutes workout "core stability"). The intervention will have a frequency of 5 days a week for 5 weeks and up to 12 weeks. The expected effect is that the experimental group patients develop better postural control at the trunk and this influences the balance in sitting, standing and walking.
Detailed Description

The deterioration in the balance sitting and poor sitting ability, clinical problems are common after stroke. These patients show a significant decrease in the performance level of the trunk, compared to healthy individuals of the same age and sex and present asymmetry of the trunk and pelvis.

Sitting involves the ability to achieve a variety of objects that are in and out of arm's length, as personal daily activities, showering, going to the bathroom and dressing. These arm movements, triggering postural adjustments in the muscles of the trunk and lower extremities, which anticipated the movement always precede the active movement. This anticipative control can be altered in subjects with stroke.

The trunk seems particularly important for balance, as stabilizes the pelvis and spine. Dean et al, (1997; 2007) and Ibrahimi (2010) showed a beneficial effect on functional scope of practice tasks, sitting in variables dynamic sitting balance, load weight of the affected side and standing. Also in the studies of Howe (2005); Verheyden (2009); Saeys (2011);Karthikbabu (2011) and Kumar (2011) with specific exercises for the trunk, favorable outcomes were obtained compared with standard treatment. However, these studies with few patients and without any monitoring, it needs to be confirmed (what is this study intended)

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Cerebral Stroke
  • Cerebrovascular Accident
Intervention  ICMJE
  • Other: Core stability
    Core stability 5 days a week during 5 weeks
    Other Name: Trunk exercises
  • Other: Standard Physiotherapy Exercises
    Standard Physiotherapy Exercises is a conventional treatment program 5 days a week during 5 weeks
    Other Name: Usual care
Study Arms  ICMJE
  • Standard Physiotherapy Exercises
    Standard Physiotherapy Exercises 5 days a week during 5 weeks
    Intervention: Other: Standard Physiotherapy Exercises
  • Experimental: Core stability
    Core stability.5 days a week during 5 weeks
    Interventions:
    • Other: Core stability
    • Other: Standard Physiotherapy Exercises
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 23, 2013)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults of either sex
  • > 18 years with a diagnosis of stroke, ischemic or hemorrhagic origin <3 months of evolution
  • Orthopedic problems not present to keep sitting. Ability to understand instructions
  • The Index Barthel ˂ 70 points and Trunk Impairment Scale ˂ 16 points.

Exclusion Criteria:

  • Patients with cognitive problems, Mini mental state examination ˂ 24
  • Patients with a second stroke confirmed by Neurology services or previous motor disability that altered the balance, or a Rankin value not superior to 3
  • The patients with stroke hemorrhagic origin with surgical treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01864382
Other Study ID Numbers  ICMJE UIC-FIS-2012-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rosa Cabanas-Valdes, Universitat Internacional de Catalunya
Study Sponsor  ICMJE Rosa Cabanas-Valdes
Collaborators  ICMJE
  • Corporacion Parc Tauli
  • Institut Investigacio Sanitaria Pere Virgili
Investigators  ICMJE
Principal Investigator: Rosa Mª Cabanas-Valdes, Kinesiology Universitat Internacional de Catalunya
Study Director: Caritat Bagur-Calafat Universitat Internacional de Catalunya
PRS Account Universitat Internacional de Catalunya
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP