Effectiveness of Balance Exercise Program for Stroke Patients With Pusher Syndrome

NCT ID: NCT03991390

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-20
• Study Completion Date: 2020-06-30

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.

Conditions

Pusher Syndrome; Subacute Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Core stability and feedback visual laser exercises

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.

Group Type: EXPERIMENTAL

Visual Feedback and Core Stability exercises protocol

Intervention Type: OTHER

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 stroke

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.

Group Type: ACTIVE_COMPARATOR

Control stroke

Intervention Type: OTHER

This arm consists of 5 sessions per week, 60 minutes each comprising usual physiotherapy treatment.

All sessions will be performed by the same physiotherapist.

Interventions

Visual Feedback and Core Stability exercises protocol

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.

Intervention Type: OTHER

Control stroke

This arm consists of 5 sessions per week, 60 minutes each comprising usual physiotherapy treatment.

All sessions will be performed by the same physiotherapist.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat Internacional de Catalunya

OTHER

Sponsor Role: collaborator

Parc Sanitari Pere Virgili

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caritat Bagur, PhD

Role: STUDY_DIRECTOR

Universitat Internacional de Catalunya

Locations

Parc Sanitari Pere Virgili

Barcelona, , Spain

Countries

Spain

Other Identifiers

Pusher Syndrome - PSPV

Identifier Type: -

Identifier Source: org_study_id