Stroke
Conditions
Interventions
Control group: 50 stroke patients referred from the Stroke Unit (Unesp Botucatu), who have an indication for the use of both ankle-foot orthoses (articulated and fixed). The randomization process will
E07.858.442.660.430.750
Sponsors
Faculdade de Medicina Botucatu
Faculdade de Medicina Botucatu
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Individuals who can use both types of orthoses in the treatment; who suffered an ischemic stroke within one year; both genders; who have a previous Rank less than or equal to 3; who are able to walk with or without a walking aid for five uninterrupted minutes; who received the orthosis through the rehabilitation clinic of the Hospital das Clínicas, Faculdade de Medicina de Botucatu
Exclusion criteria
Exclusion criteria: Lower limb amputation; non-ambulatory patients (Rankin 4 and 5); blindness; severe motor aphasia; late phase of stroke (after 12 months) and patients with progressive neuromuscular diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate functional mobility using the Tinetti Mobility and Balance scale. The data before and after the use of the orthosis will be analyzed through statistics, where p < 0.05 will be established for statistical significance.;Evaluate balance using the Timed Up Go Test. The data before and after the use of the orthosis will be analyzed through statistics, where p < 0.05 will be established for statistical significance.;Assess the level of functional ambulation using the scale Functional Ambulation Classification (FAC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the level of functional capacity using the Barthel index (BI). The data before and after the use of the orthosis will be analyzed through statistics, where p < 0.05 will be established for statistical significance.;Evaluate the levels of anxiety and depression using the Hospital Anxiety Depression Scale (HADS). The data before and after the use of the orthosis will be analyzed through statistics, where p < 0.05 will be established for statistical significance.;Evaluate the quality of life using the European (5D) Quality of Life Scale (Euroqol). The data before and after the use of the orthosis will be analyzed through statistics, where p < 0.05 will be established for statistical significance.;Evaluate the degree of severity of the neurological deficit using the NIH Stroke Scale (NIHSS). The data before and after the use of the orthosis will be analyzed through statistics, where p < 0.05 will be established for statistical significance.;Evaluate the level of disability using the modified Rankin scale (ERm). The data before and after the use of the orthosis will be analyzed through statistics, where p < 0.05 will be established for statistical significance.;Evaluate the spasticity level of the affected lower limb using the modified Ashworth scale (ASm). The data before and after the use of the orthosis will be analyzed through statistics, where p < 0.05 will be established for statistical significance.;Evaluate patient satisfaction in relation to the orthosis offered and the team that served them through the Quebec B-Quest scale (2.0), with scores ranging from 5 to 60, with higher scores indicating greater satisfaction with the equipment and with the service team.;Evaluate human functioning using the ICF (The International Classification of Functioning, Disability and Health) checklist. The presence or absence of impairment was rated in terms of the body function and structural domains (0 = none, 1 = mild, 2 = moderate, 3= severe, and 4 = complete). In the | — |
Countries
Brazil
Contacts
Public ContactGabriela de Paula
Faculdade de Medicina Botucatu
Outcome results
None listed