Clinical trial NCT03991390: Effectiveness of Balance Exercise Program for Stroke Patients With Pusher Syndrome
Official title: Effectiveness of Visual Feedback Laser and Core Stability Exercises for Balance Impairment in Subacute Stroke Patients With Pusher Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pusher Syndrome
Subacute Stroke
Keywords: Pusher syndrome
Core stability
Visual feedback
Postural control
Balance
Rehabilitation stroke
Lead sponsor: Parc Sanitari Pere Virgili
Sponsor class: OTHER
Collaborators: name: Universitat Internacional de Catalunya
First posted: 2019-06-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change of Contraversive Pushing at 30 days
timeFrame: Baseline (admission), 15 days, 30 days
measure: Change of Lateropulsion at 30 days
timeFrame: Baseline (admission), 15 days, 30 days
measure: Change of Balance at 30 days
timeFrame: Baseline (admission), 30 days
Secondary outcomes:
measure: Change of Quality of Life at 30 days
timeFrame: Baseline (admission), 30 days
measure: Change of Independence in the basic activities of daily life at 30 days
timeFrame: Baseline (admission), 30 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Parc Sanitari Pere Virgili
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Caritat Bagur, PhD
role: STUDY_DIRECTOR
References: