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

Primary Purpose

Stroke, Cerebral Stroke, Cerebrovascular Accident

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Core stability
Standard Physiotherapy Exercises
Sponsored by
Rosa Cabanas Valdés
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Trunk performance, exercise,, "core stability",, sitting balance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Parc Sanitari Pere Virgili
  • Consorci Hospitalari Parc Tauli

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Standard Physiotherapy Exercises

Core stability

Arm Description

Standard Physiotherapy Exercises 5 days a week during 5 weeks

Core stability.5 days a week during 5 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 21, 2013
Last Updated
May 21, 2021
Sponsor
Rosa Cabanas Valdés
Collaborators
Corporacion Parc Tauli, Institut Investigacio Sanitaria Pere Virgili
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1. Study Identification

Unique Protocol Identification Number
NCT01864382
Brief Title
"Core Stability" Exercises to Improve Sitting Balance in Stroke Patients
Acronym
Fisionet
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rosa Cabanas Valdés
Collaborators
Corporacion Parc Tauli, Institut Investigacio Sanitaria Pere Virgili

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebral Stroke, Cerebrovascular Accident
Keywords
Trunk performance, exercise,, "core stability",, sitting balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Physiotherapy Exercises
Arm Type
Other
Arm Description
Standard Physiotherapy Exercises 5 days a week during 5 weeks
Arm Title
Core stability
Arm Type
Experimental
Arm Description
Core stability.5 days a week during 5 weeks
Intervention Type
Other
Intervention Name(s)
Core stability
Other Intervention Name(s)
Trunk exercises
Intervention Description
Core stability 5 days a week during 5 weeks
Intervention Type
Other
Intervention Name(s)
Standard Physiotherapy Exercises
Other Intervention Name(s)
Usual care
Intervention Description
Standard Physiotherapy Exercises is a conventional treatment program 5 days a week during 5 weeks
Primary Outcome Measure Information:
Title
Dynamic sitting balance
Description
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.
Time Frame
Baseline, up to 25 sessions and follow up to 24 weeks
Secondary Outcome Measure Information:
Title
Standing balance
Description
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.
Time Frame
Baseline, up to 25 sessions and follow up to 24 weeks
Other Pre-specified Outcome Measures:
Title
Mobility and degree of disability
Description
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.
Time Frame
Baseline, up to 25 sessions and follow up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa Mª Cabanas-Valdes, Kinesiology
Organizational Affiliation
Universitat Internacional de Catalunya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Caritat Bagur-Calafat
Organizational Affiliation
Universitat Internacional de Catalunya
Official's Role
Study Director
Facility Information:
Facility Name
Parc Sanitari Pere Virgili
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08023
Country
Spain
Facility Name
Consorci Hospitalari Parc Tauli
City
Sabadell Barcelona
State/Province
Catalonia
ZIP/Postal Code
08208
Country
Spain

12. IPD Sharing Statement

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

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