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

Not Applicable

Terminated

• Conditions: Stroke; Paresis

• Registration Number: RBR-6sf2vv
• Lead Sponsor: Faculdade de Medicina Botucatu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-05
• Study Completion: 2023-09-30
• Last Update Posted: 5 March 2024

Recruitment & Eligibility

• Status: Terminated
• Sex: Not specified
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)