Pusher SyndromeNCT03991390
Effectiveness of Balance Exercise Program for Stroke Patients With Pusher Syndrome
A study testing Visual Feedback and Core Stability exercises protocol in people with Pusher Syndrome and Subacute Stroke, run by Parc Sanitari Pere Virgili at 1 site in Spain.
Trial summary
The objective of this study is to evaluate whether the application of two laser visual feedback exercises and core stability exercises can positively influence postural orientation and the perception of postural verticalization compared to conventional treatments, with the final goal of improving the balance in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pusher Syndrome, Subacute Stroke
- What is being tested?
- Visual Feedback and Core Stability exercises protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- 20 Nov 2018to 30 Jun 2020
- 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 admitted to an intermediate care unit after suffering from subacute stroke, for functional recovery.
- Diagnosis of ischemic or hemorrhagic stroke confirmed by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan.
- Pusher syndrome identified by the Scale for Contraversive Pushing (SCP) with a score of ≥2 and by Burke Lateropulsion Scale (BLS) with a value of ≥3.
Who cannot join
- Patients with severe previous functional dependence (Barthel Index ≤60)
- Patients diagnosed with dementia GDS-4 or previous severe cognitive impairment.
- Patients diagnosed with delirium.
- Patients diagnosed with Wernicke's aphasia.
- Patients with a previous severe visual deficit that prevents them from continuing activity (retinopathy, cataracts, etc.)
- Patient with a history of other causes of balance impairment.
- Patients with orthopedic conditions that difficult the performance of the proposed rehabilitation treatment.
- Patients enrolled in other research studies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Visual Feedback Laser and Core Stability Exercises for Balance Impairment in Subacute Stroke Patients With Pusher Syndrome
The objective of this study is to evaluate whether the application of two laser visual feedback exercises and core stability exercises can positively influence postural orientation and the perception of postural verticalization compared to conventional treatments, with the final goal of improving the balance in sitting and standing and the functionality in activities of daily living.
Read the detailed description
Study designed as a randomized clinical trial. The total sample (N=16) will randomized into two groups: treatment vs. control. All of them suffering from subacute stroke and pusher syndrome.
The study intervention will last 4 weeks. The control group will receive usual rehabilitation treatment for patients with stroke and pusher syndrome (60 minutes per day/5 days per week). The intervention group will receive usual rehabilitation treatment for patients with stroke and pusher syndrome (30 minutes per day/5 days per week) plus 30 minutes of therapy based on the specific protocol designed for the study. This protocol will consist of Core Stability exercises and visual feedback with lasers, both procedures will be alternated one day each.
The evaluation of the intervention program will be based on the established objectives, assessing: 1) Pushing Intensity (controversial push scale (SCP)), 2) Laterality (Burke Scale (BLS)), 3) Balance (Postural Assessment Scale for Stroke Patients (S-PASS)), 4) patient functional capacity (Barthel Index), and 5) Quality of Life (Newcastle Stroke-Specific Quality of Life Measure (NEWSQOL)). These variables will be evaluated baseline and post-intervention. Additionally, SCP, BLS and S-PASS will be assessed 15 days after starting treatment.
- Conditions
- Pusher Syndrome, Subacute Stroke
- Being tested
- Visual Feedback and Core Stability exercises protocol, Control stroke
- Keywords
- Pusher syndrome, Core stability, Visual feedback, Postural control, Balance, Rehabilitation stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Feedback and Core Stability exercises protocolOther
This arm consists of 5 sessions per week, 60 minutes each. One session consists of 30 minutes of conventional physiotherapy and 30 minutes of Core Stability exercises and laser visual feedback exercises, on alternate days.
All sessions will be performed by the same physiotherapist.
Control strokeOther
This arm consists of 5 sessions per week, 60 minutes each comprising usual physiotherapy treatment.
All sessions will be performed by the same physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Core stability and feedback visual laser exercises | Experimental | Two complementary protocols for the treatment of balance after stroke in patients with pusher syndrome were designed, including multidimensional physiotherapy exercises. Both protocols differentiate 3 levels of difficulty: Second level requires maintenance of balance sitting 5", if the patient does not succeed, stays in level 1. To move to L3 patients must stay seated 10''. Each exercise is repeated 5 times, always considering patients' levels of fatigue and safety.
Visual feedback with laser (Motion Guidance Clinical Kit, approved for therapeutic use): Through visual aid, patients' verticality is achieved by encouraging their active participation in correcting the imbalance while performing the exercises.
Core stability: The exercises have to be adapted for the pusher patient avoiding overuse of the less affected side of the body, and strengthening the muscles that stabilize the trunk. Receives: Other: Visual Feedback and Core Stability exercises protocol |
| Control stroke | Active comparator | Rehabilitation program is based on a comprehensive approach, where the patient follows a personalized plan of exercises according to the deficits, the previous situation and personal concerns. Receives: Other: Control stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Contraversive Pushing at 30 days
The Scale for Contraversive Pushing (SCP) allows to diagnose and quantify the pushing behavior of the post-stroke patient. This scale is based on the three main signs of pusher behavior:
- Symmetry of the spontaneous posture,
- Push of the upper or lower non-affected limb towards the affected side,
- Resistance to a passive correction of posture,
Assigning up to 1 point in each subscale and in each position. The maximum score is 6, this being the maximum expression of the pusher behavior.
Measured: Baseline (admission), 15 days, 30 days
Change of Lateropulsion at 30 days
The Burke Lateropulsion Scale (BLS) is a complementary scale appropriate to the "Contraversive Pushing" scale in the follow-up of patients with pusher behavior in relation to the resistance to passive correction shown by the patient in supine, turning, sitting, standing, walking and transfers scoring up to 17 points.
The scale evaluates the patient in sitting and standing position. The patient will be tilted 30º to the affected side and will be asked to return to the vertical position, according to the degrees where resistance appears will be given a score (0 there is no resistance, 1 resistance that begins at 5º, 2 the resistance begins at 10º, 3 the resistance begins above 10º) and the examiner will score if it is (0-null,1-light, 2-moderate, 3-severe) and the same will be evaluated when standing.
Interobserver reliability has been shown to be effective for therapy.
Measured: Baseline (admission), 15 days, 30 days
Change of Balance at 30 days
The S-PASS scale has been validated for post-stroke patients in Spanish. It consists of 12 items and is subdivided into two: mobility (7 items) and balance (5 items). The total score of the scale is 36 points and the score goes from 0 to 3 on each item. The scale also quantifies the help the patient needs to perform each action.
In items 1 to 4 and 8, control of the trunk is evaluated, both on the affected side and on the non-affected side. Items 5 to 7 report anticipatory postural adjustments, in transfers. Items 9 and 10 assess the balance in standing with and without help, respectively, and finally, on items 11 and 12, the one-leg support in affected and not affected leg without help.
Measured: Baseline (admission), 30 days
Secondary outcomes (2)
Change of Quality of Life at 30 days
The Newcastle Stroke-Specific Quality of Life Measure (NEWSQOL) assesses quality of life in patients suffering from ischemic or hemorrhagic stroke.
The questionnaire consists of 56 items distributed in 11 domains: mobility, activities of daily living, pain, vision, cognition, communication, feelings, interpersonal relationships, emotions, sleep and fatigue. In each item the commentary 'due to stroke' is added to differentiate the specific impact of the stroke from other health or social problems, or from natural aging process.
Each item is scored on 4 points (0 to 3). The domain scores are obtained by adding the results of the items included in that domain and then adding each domain to achieve a final score. Higher scores indicate a greater impact on the quality of life of the individual.
The time is difficult to calculate according to the patient's condition can range between 30 and 45 minutes
Measured: Baseline (admission), 30 days
Change of Independence in the basic activities of daily life at 30 days
Measured by the Barthel Index. The Barthel index is a questionnaire with 10 items that assesses the independence of the development of basic activities of daily life (eating, washing, dressing, arranging, evacuating, urinating, going to the toilet, mobile chair, walking and climbing and going down stairs) . The score ranges from 0-100, total dependence, Maximum independence. More specifically, the results are classified as follows: <20 total dependence, 21-60 severe dependence, 61-90 moderate dependence, 91-99 slight dependence, 100 independence.
Measured: Baseline (admission), 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start20 Nov 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pusher SyndromeStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc Sanitari Pere Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Internacional de Catalunya
- Responsible party
- Sponsor
- Investigators
- Caritat Bagur, PhD, Study director, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991390
- Sponsor's protocol ID
- Pusher Syndrome - PSPV
- Status last verified
- Mar 2021
- First submitted
- 12 Jun 2019
- Last updated
- 10 Mar 2021
- 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 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Visual Feedback Laser and Core Stability Exercises for Balance Impairment in Subacute Stroke Patients With Pusher Syndrome
- ClinicalTrials.gov ID
- NCT03991390
- Acronym / sponsor ID
- Pusher Syndrome - PSPV
- Conditions
- Pusher Syndrome, Subacute Stroke
- Keywords
- Pusher syndrome, Core stability, Visual feedback, Postural control, Balance, Rehabilitation stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Parc Sanitari Pere VirgiliUniversity, hospital or other
- Collaborators
- Universitat Internacional de Catalunya
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 19 Jun 2019 (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 objective of this study is to evaluate whether the application of two laser visual feedback exercises and core stability exercises can positively influence postural orientation and the perception of postural verticalization compared to conventional treatments, with the final goal of improving the balance in sitting and standing and the functionality in activities of daily living.
Detailed description
Study designed as a randomized clinical trial. The total sample (N=16) will randomized into two groups: treatment vs. control. All of them suffering from subacute stroke and pusher syndrome.
The study intervention will last 4 weeks. The control group will receive usual rehabilitation treatment for patients with stroke and pusher syndrome (60 minutes per day/5 days per week). The intervention group will receive usual rehabilitation treatment for patients with stroke and pusher syndrome (30 minutes per day/5 days per week) plus 30 minutes of therapy based on the specific protocol designed for the study. This protocol will consist of Core Stability exercises and visual feedback with lasers, both procedures will be alternated one day each.
The evaluation of the intervention program will be based on the established objectives, assessing: 1) Pushing Intensity (controversial push scale (SCP)), 2) Laterality (Burke Scale (BLS)), 3) Balance (Postural Assessment Scale for Stroke Patients (S-PASS)), 4) patient functional capacity (Barthel Index), and 5) Quality of Life (Newcastle Stroke-Specific Quality of Life Measure (NEWSQOL)). These variables will be evaluated baseline and post-intervention. Additionally, SCP, BLS and S-PASS will be assessed 15 days after starting treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core stability and feedback visual laser exercises | Experimental | Other: Visual Feedback and Core Stability exercises protocolTwo complementary protocols for the treatment of balance after stroke in patients with pusher syndrome were designed, including multidimensional physiotherapy exercises. Both protocols differentiate 3 levels of difficulty: Second level requires maintenance of balance sitting 5", if the patient does not succeed, stays in level 1. To move to L3 patients must stay seated 10''. Each exercise is repeated 5 times, always considering patients' levels of fatigue and safety. Visual feedback with laser (Motion Guidance Clinical Kit, approved for therapeutic use): Through visual aid, patients' verticality is achieved by encouraging their active participation in correcting the imbalance while performing the exercises. Core stability: The exercises have to be adapted for the pusher patient avoiding overuse of the less affected side of the body, and strengthening the muscles that stabilize the trunk. |
| Control stroke | Active comparator | Other: Control strokeRehabilitation program is based on a comprehensive approach, where the patient follows a personalized plan of exercises according to the deficits, the previous situation and personal concerns. |
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 admitted to an intermediate care unit after suffering from subacute stroke, for functional recovery.
- Diagnosis of ischemic or hemorrhagic stroke confirmed by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan.
- Pusher syndrome identified by the Scale for Contraversive Pushing (SCP) with a score of ≥2 and by Burke Lateropulsion Scale (BLS) with a value of ≥3.
Key exclusion criteria (8 listed)
- Patients with severe previous functional dependence (Barthel Index ≤60)
- Patients diagnosed with dementia GDS-4 or previous severe cognitive impairment.
- Patients diagnosed with delirium.
- Patients diagnosed with Wernicke's aphasia.
- Patients with a previous severe visual deficit that prevents them from continuing activity (retinopathy, cataracts, 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 |
|---|---|---|
| Visual Feedback and Core Stability exercises protocolThis arm consists of 5 sessions per week, 60 minutes each. One session consists of 30 minutes of conventional physiotherapy and 30 minutes of Core Stability exercises and laser visual feedback exercises, on alternate days. All sessions will be performed by the same physiotherapist. | Other | Core stability and feedback visual laser exercises |
| Control strokeThis arm consists of 5 sessions per week, 60 minutes each comprising usual physiotherapy treatment. All sessions will be performed by the same physiotherapist. | Other | Control stroke |
Primary outcome
Change of Contraversive Pushing at 30 days
Time frame: Baseline (admission), 15 days, 30 days
The Scale for Contraversive Pushing (SCP) allows to diagnose and quantify the pushing behavior of the post-stroke patient. This scale is based on the three main signs of pusher behavior: * Symmetry of the spontaneous posture, * Push of the upper or lower non-affected limb towards the affected side, * Resistance to a passive correction of posture, Assigning up to 1 point in each subscale and in each position. The maximum score is 6, this being the maximum expression of the pusher behavior.
Change of Lateropulsion at 30 days
Time frame: Baseline (admission), 15 days, 30 days
The Burke Lateropulsion Scale (BLS) is a complementary scale appropriate to the "Contraversive Pushing" scale in the follow-up of patients with pusher behavior in relation to the resistance to passive correction shown by the patient in supine, turning, sitting, standing, walking and transfers scoring up to 17 points. The scale evaluates the patient in sitting and standing position. The patient will be tilted 30º to the affected side and will be asked to return to the vertical position, according to the degrees where resistance appears will be given a score (0 there is no resistance, 1 resistance that begins at 5º, 2 the resistance begins at 10º, 3 the resistance begins above 10º) and the examiner will score if it is (0-null,1-light, 2-moderate, 3-severe) and the same will be evaluated when standing. Interobserver reliability has been shown to be effective for therapy.
Change of Balance at 30 days
Time frame: Baseline (admission), 30 days
The S-PASS scale has been validated for post-stroke patients in Spanish. It consists of 12 items and is subdivided into two: mobility (7 items) and balance (5 items). The total score of the scale is 36 points and the score goes from 0 to 3 on each item. The scale also quantifies the help the patient needs to perform each action. In items 1 to 4 and 8, control of the trunk is evaluated, both on the affected side and on the non-affected side. Items 5 to 7 report anticipatory postural adjustments, in transfers. Items 9 and 10 assess the balance in standing with and without help, respectively, and finally, on items 11 and 12, the one-leg support in affected and not affected leg without help.
2 secondary outcomes
Change of Quality of Life at 30 days
Time frame: Baseline (admission), 30 days
Change of Independence in the basic activities of daily life at 30 days
Time frame: Baseline (admission), 30 days
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 10 Mar 2021.
- Individual participant dataSharing planned: No
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, PhD 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 Visual Feedback and Core Stability exercises protocol in people with Pusher Syndrome and Subacute Stroke, run by Parc Sanitari Pere Virgili 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 8 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 10 Mar 2021. 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 of Contraversive Pushing at 30 days (time frame: Baseline (admission), 15 days, 30 days). The study lists 3 primary outcomes in all. 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 10 Mar 2021.