Custom-made articulated ankle-foot Orthoses associated with home-based mobility tasks improve functional mobility and autonomy compared with fixed Orthoses in patients with Stroke: A Randomized Clinical Trial

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2018
INTERVENTION: Control group: 50 patients with stroke referred from the stroke unit (Unesp Botucatu), who have indication for use of both ankle‐foot orthotic (articulated and fixed), will be randomized to receive one of the two types of orthoses . Experimental group: the same 50 patients will be reassessed after 30 days of using the orthosis. The orthoses were distributed to these 50 patients in a randomized way, they will be used by the patients for 30 days, with this we will check if either one shows superior performance in the motor function or in the balance through specific tests. Device E07.858.442.660.430.750 E07.858.442.743 CONDITION: C10.228.140.300.775 C10.597.636 Nervous system disorders; Stroke; Cerebrovascular diseases; Paresis. ; I67.8 ; C10.228.140.300.775 ; C10.597.636 PRIMARY OUTCOME: Improvement of motor function in gait and balance after orthosis use can be detected by improving the results (indices) in the Tinetti Mobility and Equilibrium (EMET) scale and the time up go (TUG) test for balance, speed and risk of falls, the data before and after the use of the orthosis will be analyzed through statistics, where it will be established p <0.05 for statistical significance. SECONDARY OUTCOME: Functional capacity, quality of life, anxiety and depression levels, and patients' muscle tone will also be analyzed again after 30 days of ankle‐foot orthosis, to verify if there was improvement in the results (indexes) with orthosis use in the (ANM), the modified scaleim (ERm), NIH Stroke Scale (NIHSS), European (5D) Quality of Life Scale (Euroqol), Hospital Anxiety Depression Scale (HADS) and modified Ashworth scale (EAm) use of the orthosis will be analyzed through statistics, where it will be established p <0.05 for statistical significance. INCLUSION CRITERIA: Patients who may use both types of orthoses in treatment; who have suffered a stroke within a year; both sex; who have a previous Rankim of less than or equal to 3, who receive the AFO orthosis through the rehabilitation outpatient clinic of the Hospital das Clínicas of the Faculty of Medicine of Botucatu; have an indication for use of an AFO orthosis.
Epistemonikos ID: 96a0338d2ac0cdf0bc8a59e0c8b0602762793988
First added on: Aug 24, 2024