Balance Systems Protocol for Subacute Phase Stroke Patients. (BSPStroke)

Universitat Internacional de Catalunya

Status: Completed

Conditions: Stroke Sequelae

Treatments: Other: Balance System Protocol Stroke; Other: Control Stroke

Study type: Interventional

Funder types: Other

Identifiers

NCT03406026

3669 CEEAH

Details and patient eligibility

About

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.

Full description

In order to respond to the objectives, a randomized clinical trial was proposed on a total N of 70 stroke survivors (N = 35 patients in the control group and N = 35 patients in the intervention group), who Are in the subacute stage of the disease, meet the inclusion and exclusion criteria, and require hospitalization to perform the rehabilitative treatment.

For this, a rehabilitation treatment protocol was designed focusing on the equilibrium systems. The intervention of the study will be carried out during 4 weeks. The control group will receive conventional rehabilitation treatment for stroke patients, consisting of physiotherapy therapy for 60 minutes; While the intervention group will receive conventional rehabilitative treatment during the first 45 minutes and the last 15 minutes therapy will be based on the protocol designed.

The evaluation of the program will be carried out based on the stated objectives. In order to evaluate the improvement of the patients in terms of balance, gait, risk of falls and patient autonomy, these will be assessed at the beginning of the intervention at 15 days and at the end (30 days). After the intervention two more assessments will be made; At 3 months and at 6 months to follow up in time.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 2 patient groups

Balance System Protocol Stroke

Experimental group

Description:

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.

Treatment:

Other: Balance System Protocol Stroke

Control Stroke

Active Comparator group

Description:

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.

Treatment:

Other: Control Stroke