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

Sponsor
Rosa Cabanas Valdés (Other)
Overall Status
Completed
CT.gov ID
NCT01864382
Collaborator
Corporacion Parc Tauli (Other), Institut Investigacio Sanitaria Pere Virgili (Other)
80
2
2
23
40
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Core stability
  • Other: Standard Physiotherapy Exercises
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, 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.
Study Start Date :
Oct 1, 2012
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Sep 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Other: 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 Names:
  • 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 Names:
  • Trunk exercises
  • Other: Standard Physiotherapy Exercises
    Standard Physiotherapy Exercises is a conventional treatment program 5 days a week during 5 weeks
    Other Names:
  • Usual care
  • Outcome Measures

    Primary Outcome Measures

    1. Dynamic sitting balance [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.

    Secondary Outcome Measures

    1. Standing balance [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.

    Other Outcome Measures

    1. Mobility and degree of disability [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Parc Sanitari Pere Virgili Barcelona Catalonia Spain 08023
    2 Consorci Hospitalari Parc Tauli Sabadell Barcelona Catalonia Spain 08208

    Sponsors and Collaborators

    • Rosa Cabanas Valdés
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rosa Cabanas Valdés, Instructor of the Physical Therapy teaching staff, Universitat Internacional de Catalunya
    ClinicalTrials.gov Identifier:
    NCT01864382
    Other Study ID Numbers:
    • UIC-FIS-2012-04
    First Posted:
    May 29, 2013
    Last Update Posted:
    May 24, 2021
    Last Verified:
    May 1, 2021
    Keywords provided by Rosa Cabanas Valdés, Instructor of the Physical Therapy teaching staff, Universitat Internacional de Catalunya
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 24, 2021