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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01864382
Other study ID # UIC-FIS-2012-04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2012
Est. completion date September 2014

Study information

Verified date May 2021
Source Universitat Internacional de Catalunya
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Core stability
Core stability 5 days a week during 5 weeks
Standard Physiotherapy Exercises
Standard Physiotherapy Exercises is a conventional treatment program 5 days a week during 5 weeks

Locations

Country Name City State
Spain Parc Sanitari Pere Virgili Barcelona Catalonia
Spain Consorci Hospitalari Parc Tauli Sabadell Barcelona Catalonia

Sponsors (3)

Lead Sponsor Collaborator
Rosa Cabanas Valdés Corporacion Parc Tauli, Institut Investigacio Sanitaria Pere Virgili

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Mobility and degree of disability 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. Baseline, up to 25 sessions and follow up to 24 weeks
Primary Dynamic sitting balance 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. Baseline, up to 25 sessions and follow up to 24 weeks
Secondary Standing balance 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. Baseline, up to 25 sessions and follow up to 24 weeks
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