StrokeFisionetNCT01864382
"Core Stability" Exercises to Improve Sitting Balance in Stroke Patients
A study testing Core stability and Standard Physiotherapy Exercises in people with Stroke and Cerebral Stroke, run by Rosa Cabanas Valdés at 2 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebral Stroke, Cerebrovascular Accident
- What is being tested?
- Core stability and Standard Physiotherapy Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesSpain
- Study dates
- Oct 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Parc Sanitari Pere Virgili
Barcelona, Catalonia, 08023
Consorci Hospitalari Parc Tauli
Sabadell Barcelona, Catalonia, 08208
About this study
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.
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.
Read the 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)
- Conditions
- Stroke, Cerebral Stroke, Cerebrovascular Accident
- Being tested
- Core stability, Standard Physiotherapy Exercises
- Keywords
- Trunk performance, exercise,, "core stability",, sitting balance
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stabilityOther
Also called Trunk exercises
Core stability 5 days a week during 5 weeks
Standard Physiotherapy ExercisesOther
Also called Usual care
Standard Physiotherapy Exercises is a conventional treatment program 5 days a week during 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Standard Physiotherapy Exercises | Other | Standard Physiotherapy Exercises 5 days a week during 5 weeks Receives: Other: Standard Physiotherapy Exercises |
| Core stability | Experimental | Core stability.5 days a week during 5 weeks Receives: Other: Core stability; Other: Standard Physiotherapy Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, up to 25 sessions and follow up to 24 weeks
Secondary outcomes (1)
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.
Measured: Baseline, up to 25 sessions and follow up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startOct 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rosa Cabanas Valdés
- Sponsor type
- University, hospital or other
- Collaborators
- Corporacion Parc Tauli, Institut Investigacio Sanitaria Pere Virgili
- Responsible party
- Sponsor-investigator, Rosa Cabanas Valdés, Universitat Internacional de Catalunya
- Investigators
- Rosa Mª Cabanas-Valdes, Kinesiology, Principal investigator, Universitat Internacional de CatalunyaCaritat Bagur-Calafat, Study director, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864382
- Sponsor's protocol ID
- UIC-FIS-2012-04
- Acronym
- Fisionet
- Status last verified
- May 2021
- First submitted
- 21 May 2013
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01864382
- Acronym / sponsor ID
- Fisionet / UIC-FIS-2012-04
- Conditions
- Stroke, Cerebral Stroke, Cerebrovascular Accident
- Keywords
- Trunk performance, exercise,, "core stability",, sitting balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Rosa Cabanas ValdésUniversity, hospital or other
- Collaborators
- Corporacion Parc Tauli, Institut Investigacio Sanitaria Pere Virgili
- Study start
- Oct 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Physiotherapy Exercises | Other | Other: Standard Physiotherapy ExercisesStandard Physiotherapy Exercises 5 days a week during 5 weeks |
| Core stability | Experimental | Other: Core stability, Other: Standard Physiotherapy ExercisesCore stability.5 days a week during 5 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core stabilityAlso: Trunk exercisesCore stability 5 days a week during 5 weeks | Other | Core stability |
| Standard Physiotherapy ExercisesAlso: Usual careStandard Physiotherapy Exercises is a conventional treatment program 5 days a week during 5 weeks | Other | Core stability, Standard Physiotherapy Exercises |
Primary outcome
Dynamic sitting balance
Time frame: 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.
1 secondary outcome
Standing balance
Time frame: Baseline, up to 25 sessions and follow up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Mª Cabanas-Valdes, Kinesiology principal investigator
Universitat Internacional de Catalunya
Caritat Bagur-Calafat study director
Universitat Internacional de Catalunya
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stability and Standard Physiotherapy Exercises in people with Stroke and Cerebral Stroke, run by Rosa Cabanas Valdés at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic sitting balance (time frame: Baseline, up to 25 sessions and follow up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.