Balance Systems Protocol for Subacute Phase Stroke Patients.

NCT03406026 | Completed

• 1 other identifier: 3669 CEEAH
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke Sequelae

Keywords

Stroke; Balance rehabilitation; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline, 15 days, 1 month

Secondary Outcomes (3)

• Gait

  At baseline, 15 days, 1 month

• Falling risk

  At baseline, 15 days, 1 month

• Independence in basic activities of daily life

  At baseline, 15 days, 1 moth

Study Arms (2)

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.

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.

Other: Control Stroke

Interventions

Balance System Protocol Stroke OTHER

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.

Balance System Protocol Stroke

Control Stroke OTHER

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.

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, 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead
• Institut Investigacio Sanitaria Pere Virgili: collaborator

Study Sites (1)

Centro Hospitalario Pere Virgili

Barcelona, 08022, Spain

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Caritat Bagur, Physio

  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: PRINCIPAL INVESTIGATOR
• PI Title: Msc

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: January 23, 2018
• Study Start: March 27, 2017
• Primary Completion: June 30, 2018
• Study Completion: July 15, 2018
• Last Updated: November 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)