Clinical trial NCT01864382: "Core Stability" Exercises to Improve Sitting Balance in Stroke Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Cerebral Stroke
Cerebrovascular Accident
Keywords: Trunk performance
exercise,
"core stability",
sitting balance
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
Collaborators: name: Corporacion Parc Tauli
name: Institut Investigacio Sanitaria Pere Virgili
First posted: 2013-05-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility 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.

Primary outcomes:
measure: Dynamic sitting balance
timeFrame: Baseline, up to 25 sessions and follow up to 24 weeks
Secondary outcomes:
measure: Standing balance
timeFrame: Baseline, up to 25 sessions and follow up to 24 weeks
Other outcomes:
measure: Mobility and degree of disability
timeFrame: Baseline, up to 25 sessions and follow up to 24 weeks
Locations:
city: Barcelona
country: Spain
facility: Parc Sanitari Pere Virgili
state: Catalonia
city: Sabadell Barcelona
country: Spain
facility: Consorci Hospitalari Parc Tauli
state: Catalonia
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Rosa Mª Cabanas-Valdes, Kinesiology
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat Internacional de Catalunya
name: Caritat Bagur-Calafat
role: STUDY_DIRECTOR
References: