Clinical trial NCT03406026: Balance Systems Protocol for Subacute Phase Stroke Patients.
Official title: Evaluation of the Effect of the Protocol Focused on the Balance Systems in Patients Who Are in the Subacute Phase of the Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Sequelae
Keywords: Stroke
Balance rehabilitation
Physiotherapy
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
Collaborators: name: Institut Investigacio Sanitaria Pere Virgili
First posted: 2018-01-23
Enrollment: 65
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 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Balance
timeFrame: At baseline, 15 days, 1 month
Secondary outcomes:
measure: Gait
timeFrame: At baseline, 15 days, 1 month
measure: Falling risk
timeFrame: At baseline, 15 days, 1 month
measure: Independence in basic activities of daily life
timeFrame: At baseline, 15 days, 1 moth
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Centro Hospitalario Pere Virgili
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Caritat Bagur, Physio
role: STUDY_DIRECTOR
References: