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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Universitat Internacional de Catalunya
Sponsor:
Collaborators:
Corporacion Parc Tauli
Institut Investigacio Sanitaria Pere Virgili
Information provided by (Responsible Party):
Rosa Cabanas-Valdes, Universitat Internacional de Catalunya
ClinicalTrials.gov Identifier:
NCT01864382
First received: May 21, 2013
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Stroke
Cerebral Stroke
Cerebrovascular Accident
Other: Core stability
Other: Standard Physiotherapy Exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Universitat Internacional de Catalunya:

Primary Outcome Measures:
  • Dynamic sitting balance [ Time Frame: Baseline, up to 25 sessions and follow up to 24 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Standing balance [ Time Frame: Baseline, up to 25 sessions and follow up to 24 weeks ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Mobility and degree of disability [ Time Frame: Baseline, up to 25 sessions and follow up to 24 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 80
Study Start Date: October 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Standard Physiotherapy Exercises
Standard Physiotherapy Exercises 5 days a week during 5 weeks
Other: Standard Physiotherapy Exercises
Standard Physiotherapy Exercises is a conventional treatment program 5 days a week during 5 weeks
Other Name: Usual care
Experimental: Core stability
Core stability.5 days a week during 5 weeks
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

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01864382

Contacts
Contact: Rosa M Cabanas-Valdes, MsC 0034 93 504 20 04 rosacabanas@uic.es

Locations
Spain
Parc Sanitari Pere Virgili Recruiting
Barcelona, Catalonia, Spain, 08023
Contact: Mireia Camó, MsC    0034 93 259 40 52    MCamo@perevirgili.catsalut.net   
Sub-Investigator: Caritat Bagur-Calafat, PhD         
Consorci Hospitalari Parc Tauli Recruiting
Sabadell Barcelona, Catalonia, Spain, 08208
Contact: Xavier Bel, Headman    0034 937 45 84 05    xavierbel@msn.com   
Sub-Investigator: Gerard Urrutia, PhD         
Sponsors and Collaborators
Rosa Cabanas-Valdes
Corporacion Parc Tauli
Institut Investigacio Sanitaria Pere Virgili
Investigators
Principal Investigator: Rosa Mª Cabanas-Valdes, Kinesiology Universitat Internacional de Catalunya
Study Director: Caritat Bagur-Calafat Universitat Internacional de Catalunya
  More Information

No publications provided

Responsible Party: Rosa Cabanas-Valdes, Instructor of the Physical Therapy teaching staff, Universitat Internacional de Catalunya
ClinicalTrials.gov Identifier: NCT01864382     History of Changes
Other Study ID Numbers: UIC-FIS-2012-04
Study First Received: May 21, 2013
Last Updated: May 23, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Universitat Internacional de Catalunya:
Trunk performance
exercise,
"core stability",
sitting balance

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

ClinicalTrials.gov processed this record on July 20, 2014