Stroke SequelaeBSPStrokeNCT03406026
Balance Systems Protocol for Subacute Phase Stroke Patients.
A study testing Balance System Protocol Stroke in people with Stroke Sequelae, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
The aim of the study is to evaluate if the application of a protocol focused on the equilibrium systems versus the conventional treatments decreases the time to acquire equilibrium in standing, the risk of falls and favors the early initiation of treatments aimed at recovering the physiological gait. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Sequelae
- What is being tested?
- Balance System Protocol Stroke
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSpain
- Study dates
- 27 Mar 2017to 15 Jul 2018
- 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
- Patients ≥ 18 years, who are admitted to an intermediate care unit after an acute stroke, for functional recovery.
- Diagnosis of ischemic or hemorrhagic stroke confirmed by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan.
- Patients with no alteration on sitting balance: patients should be able to sit on the edge of the bed with the hip and knees on 90º flexion, feet flat on the floor and inclination forward 30º towards the healthy and paretic side and able to return to the vertical balance without any support of the back or upper limbs.
Who cannot join
- Patients with severe prior functional dependence (Barthel Index ≤60)
- Patients diagnosed with dementia or previous cognitive impairment
- Patients diagnosed with delirium.
- Patients diagnosed with Wernicke aphasia.
- Patients with previous visual deficit (retinopathy, cataract, etc.)
- Patient with a history of other causes of balance impairment.
- Patients with orthopedic conditions that difficult the performance of the proposed rehabilitation treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of the Protocol Focused on the Balance Systems in Patients Who Are in the Subacute Phase of the Stroke
The aim of the study is to evaluate if the application of a protocol focused on the equilibrium systems versus the conventional treatments decreases the time to acquire equilibrium in standing, the risk of falls and favors the early initiation of treatments aimed at recovering the physiological gait.
Read the detailed description
In order to respond to the objectives, a randomized clinical trial was proposed on a total N of 70 stroke survivors (N = 35 patients in the control group and N = 35 patients in the intervention group), who Are in the subacute stage of the disease, meet the inclusion and exclusion criteria, and require hospitalization to perform the rehabilitative treatment.
For this, a rehabilitation treatment protocol was designed focusing on the equilibrium systems. The intervention of the study will be carried out during 4 weeks. The control group will receive conventional rehabilitation treatment for stroke patients, consisting of physiotherapy therapy for 60 minutes; While the intervention group will receive conventional rehabilitative treatment during the first 45 minutes and the last 15 minutes therapy will be based on the protocol designed.
The evaluation of the program will be carried out based on the stated objectives. In order to evaluate the improvement of the patients in terms of balance, gait, risk of falls and patient autonomy, these will be assessed at the beginning of the intervention at 15 days and at the end (30 days). After the intervention two more assessments will be made; At 3 months and at 6 months to follow up in time.
- Conditions
- Stroke Sequelae
- Being tested
- Balance System Protocol Stroke, Control Stroke
- Keywords
- Stroke, Balance rehabilitation, Physiotherapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance System Protocol StrokeOther
This arm perform 5 sessions of 1 hour a week. All sessions will be performed by the same physiotherapist. One session consists of 45 minutes of regular physiotherapy and 15 minutes in which exercises will be carried out focused on the balance systems, following the program that is detailed below.
Control StrokeOther
This arm perform 5 sessions of 1 hour a week. All sessions will be performed by the same physiotherapist. The control group will perform, during the 60 minutes that the session lasts, the usual physiotherapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| Balance System Protocol Stroke | Experimental | Balance System Protocol Stroke differentiates 2 levels of difficulty in relation to the patient's condition and progressively according to their evolution. If the patient maintains stability in standing for at least 30 s, he starts in Level 2 and otherwise he will remain in Level 1 until he acquires it. In level 1 the progression of exercises is: 1.Pressure stimulation of the foot support points; 2.Proprioceptive ankle work; 3.Sit-to-stand work and vice versa; 4.Sit-to-stand work with delayed affection. In level 2, the progression of exercises is: 1.Standing unbalances; 2.Standing on Balance-pad; 3.Work to get monopodal support; 4.Balance pad in monopodal support; 5.Monopodal support work with closed eyes. Receives: Other: Balance System Protocol Stroke |
| Control Stroke | Active comparator | The program of Control Stroke arm is based on an integral and rehabilitative approach in which the patient follows a personalized plan of exercises and therapies according to the deficits of each patient, the previous situation, the personal concerns with In order to perform a person-centered approach. Receives: Other: Control Stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Balance
The main aim of the study is to test that evaluates the dynamic balance with Mini Balance Evaluation Systems Test. It is an essay that lasts for about 10 minutes, which makes the patient not find a tiredness. It consists of four sections with a total of 14 elements that evaluate each of the systems elements of the balance: biomechanical limitations, stability limits, postural responses, posterior adjustments anticipatory, sensory orientation, dynamic balance and cognitive effects during gait.
It is score by assigning 2 points if the performance is normal, 1 point if the deficit is moderate and 0 points if the deficit is severe. In the case that the patient needs external support, on point will be subtracted from the score obtained on the category evaluated. Finally, if the patient need help from the physiotherapist, the category will be scored as 0 points. The paretic and the non-paretic side will be assessed, and the worse scored will be recorded.
Measured: At baseline, 15 days, 1 month
Secondary outcomes (3)
Gait
It will also be evaluated through the Mini Balance Evaluation Systems Test (Mini BESTest)
Measured: At baseline, 15 days, 1 month
Falling risk
Measured by the Berg Balance Scale (BBS) The Berg is a widely used test for assessing balance and to predict falls risk in the elderly. It has been validated with post-stroke patients. The Berg consists of 14 items, each scored from 0-4. Thus a score for the Berg could in theory range from a minimum of 0 to a maximum of 56. A score below 45 is indicative of balance impairment; thus the lower the score the greater the falls risk. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effect ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.
Measured: At baseline, 15 days, 1 month
Independence in basic activities of daily life
Measured by the Barthel Index. The Barthel index is a questionnaire with 10 items that values independence for the development of basic activities of daily living (eating, washing, dressing, arranging, stool, urination, going to the retete, moving chair, walking and climbing And down stairs). The score goes from 0-100, total dependence, maximum independence. More specifically, the results are categorized as follows: <20 total dependence, 21-60 severe dependence, 61-90 moderate dependence, 91-99 mild dependence, 100 independence.
Measured: At baseline, 15 days, 1 moth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start27 Mar 2017
- Primary completion30 Jun 2018
- Study completion15 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SequelaeStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Investigacio Sanitaria Pere Virgili
- Responsible party
- Principal investigator, Almudena Medina Rincón, Universitat Internacional de Catalunya
- Investigators
- Caritat Bagur, Physio, Study director, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406026
- Sponsor's protocol ID
- 3669 CEEAH
- Acronym
- BSPStroke
- Status last verified
- Nov 2018
- First submitted
- 18 Dec 2017
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of the Protocol Focused on the Balance Systems in Patients Who Are in the Subacute Phase of the Stroke
- ClinicalTrials.gov ID
- NCT03406026
- Acronym / sponsor ID
- BSPStroke / 3669 CEEAH
- Conditions
- Stroke Sequelae
- Keywords
- Stroke, Balance rehabilitation, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Collaborators
- Institut Investigacio Sanitaria Pere Virgili
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 15 Jul 2018 (actual)
- First posted
- 23 Jan 2018 (actual)
- 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 aim of the study is to evaluate if the application of a protocol focused on the equilibrium systems versus the conventional treatments decreases the time to acquire equilibrium in standing, the risk of falls and favors the early initiation of treatments aimed at recovering the physiological gait.
Detailed description
In order to respond to the objectives, a randomized clinical trial was proposed on a total N of 70 stroke survivors (N = 35 patients in the control group and N = 35 patients in the intervention group), who Are in the subacute stage of the disease, meet the inclusion and exclusion criteria, and require hospitalization to perform the rehabilitative treatment.
For this, a rehabilitation treatment protocol was designed focusing on the equilibrium systems. The intervention of the study will be carried out during 4 weeks. The control group will receive conventional rehabilitation treatment for stroke patients, consisting of physiotherapy therapy for 60 minutes; While the intervention group will receive conventional rehabilitative treatment during the first 45 minutes and the last 15 minutes therapy will be based on the protocol designed.
The evaluation of the program will be carried out based on the stated objectives. In order to evaluate the improvement of the patients in terms of balance, gait, risk of falls and patient autonomy, these will be assessed at the beginning of the intervention at 15 days and at the end (30 days). After the intervention two more assessments will be made; At 3 months and at 6 months to follow up in time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance System Protocol Stroke | Experimental | Other: Balance System Protocol StrokeBalance System Protocol Stroke differentiates 2 levels of difficulty in relation to the patient's condition and progressively according to their evolution. If the patient maintains stability in standing for at least 30 s, he starts in Level 2 and otherwise he will remain in Level 1 until he acquires it. In level 1 the progression of exercises is: 1.Pressure stimulation of the foot support points; 2.Proprioceptive ankle work; 3.Sit-to-stand work and vice versa; 4.Sit-to-stand work with delayed affection. In level 2, the progression of exercises is: 1.Standing unbalances; 2.Standing on Balance-pad; 3.Work to get monopodal support; 4.Balance pad in monopodal support; 5.Monopodal support work with closed eyes. |
| Control Stroke | Active comparator | Other: Control StrokeThe program of Control Stroke arm is based on an integral and rehabilitative approach in which the patient follows a personalized plan of exercises and therapies according to the deficits of each patient, the previous situation, the personal concerns with In order to perform a person-centered approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥ 18 years, who are admitted to an intermediate care unit after an acute stroke, for functional recovery.
- Diagnosis of ischemic or hemorrhagic stroke confirmed by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan.
- Patients with no alteration on sitting balance: patients should be able to sit on the edge of the bed with the hip and knees on 90º flexion, feet flat on the floor and inclination forward 30º towards the healthy and paretic side and able to return to the vertical balance without any support of the back or upper limbs.
Key exclusion criteria (7 listed)
- Patients with severe prior functional dependence (Barthel Index ≤60)
- Patients diagnosed with dementia or previous cognitive impairment
- Patients diagnosed with delirium.
- Patients diagnosed with Wernicke aphasia.
- Patients with previous visual deficit (retinopathy, cataract, etc.)
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 |
|---|---|---|
| Balance System Protocol StrokeThis arm perform 5 sessions of 1 hour a week. All sessions will be performed by the same physiotherapist. One session consists of 45 minutes of regular physiotherapy and 15 minutes in which exercises will be carried out focused on the balance systems, following the program that is detailed below. | Other | Balance System Protocol Stroke |
| Control StrokeThis arm perform 5 sessions of 1 hour a week. All sessions will be performed by the same physiotherapist. The control group will perform, during the 60 minutes that the session lasts, the usual physiotherapy treatment. | Other | Control Stroke |
Primary outcome
Change from baseline Balance
Time frame: At baseline, 15 days, 1 month
The main aim of the study is to test that evaluates the dynamic balance with Mini Balance Evaluation Systems Test. It is an essay that lasts for about 10 minutes, which makes the patient not find a tiredness. It consists of four sections with a total of 14 elements that evaluate each of the systems elements of the balance: biomechanical limitations, stability limits, postural responses, posterior adjustments anticipatory, sensory orientation, dynamic balance and cognitive effects during gait. It is score by assigning 2 points if the performance is normal, 1 point if the deficit is moderate and 0 points if the deficit is severe. In the case that the patient needs external support, on point will be subtracted from the score obtained on the category evaluated. Finally, if the patient need help from the physiotherapist, the category will be scored as 0 points. The paretic and the non-paretic side will be assessed, and the worse scored will be recorded.
3 secondary outcomes
Gait
Time frame: At baseline, 15 days, 1 month
Falling risk
Time frame: At baseline, 15 days, 1 month
Independence in basic activities of daily life
Time frame: At baseline, 15 days, 1 moth
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 6 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Caritat Bagur, Physio study director
Universitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance System Protocol Stroke in people with Stroke Sequelae, run by Universitat Internacional de Catalunya at 1 site 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 3 inclusion and 7 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 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change from baseline Balance (time frame: At baseline, 15 days, 1 month). 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 6 Nov 2018.