Effectiveness of Balance Exercise Program for Stroke Patients With Pusher Syndrome

NCT03991390 | Completed

• 1 other identifier: Pusher Syndrome - PSPV
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Pusher Syndrome; Subacute Stroke

Keywords

Pusher syndrome; Core stability; Visual feedback; Postural control; Balance; Rehabilitation stroke

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline (admission), 30 days

Secondary Outcomes (2)

• Change of Quality of Life at 30 days

  Baseline (admission), 30 days

• Change of Independence in the basic activities of daily life at 30 days

  Baseline (admission), 30 days

Study Arms (2)

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.

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.

Other: Control stroke

Interventions

Visual Feedback and Core Stability exercises protocol 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.

Core stability and feedback visual laser exercises

Control stroke 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.

Control stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parc Sanitari Pere Virgili: lead
• Universitat Internacional de Catalunya: collaborator

Study Sites (1)

Parc Sanitari Pere Virgili

Barcelona, 08022, Spain

Location

MeSH Terms

Interventions

Feedback, Sensory

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Feedback, Physiological; Homeostasis; Physiological Phenomena

Study Officials

• Caritat Bagur, PhD

  Universitat Internacional de Catalunya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 19, 2019
• Study Start: November 20, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)