Preliminary Biomechanical and Usability Study of an Active Ankle-Foot Orthesis for Stroke Survivors

Corporación de Rehabilitación Club de Leones Cruz del Sur10 enrolled

Overview

This research will present the biomechanical assessment of a robotic device for ankle assistance during gait on stroke's survivors with hemiparesis. Gait pattern through an optoelectronic motion capture system will be analyzed. Additionally, ergonomic and comfort aspects will be measured by an adapted spanish version of Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)

This research will present the biomechanical assessment of a robotic device for ankle assistance during gait on stroke's survivors with hemiparesis. The device is composed by a passive orthosis structure which allows one degree of freedom (DOF) among the sagittal plane and it includes two servomotors attached to the user's foot through velcro strips. Gait pattern through an optoelectronic motion capture system will be analyzed. Additionally, ergonomic and comfort aspects will be measured by an adapted spanish version of Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke

Interventions

Assisted gait with a motorized ankle foot orthosisDEVICE

The motorized ankle foot orthosis is a powered lower extremity assistance device with an actuated ankle joint. A novel control software has been design and implemented in this device, which allows precise joint movement and recording of data from training session.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hemiparesis caused by a stroke. * Age between 18 and 65 years old. * Post-stroke time more than 6 months. * Independent walking. * Minimum 90 degrees of dorsiflexion. * Muscle tone in plantar flexors less than of equal to 3 on the Modified Ashworth scale. * Ability to follow instructions. * Voluntary participation. Exclusion Criteria: * Skin alterations in the lower limb. * Peripherical vascular alterations. * Alterations in sensitivity in the lower limb. * Pain of musculoskeletal origin in lower extremities or spine. * History of frequent falls. * Cancer * Previous history or suspected seizures. * Patient who does not sign the informed consent.

Locations (1)

Corporación de Rehabilitación Club de Leones Cruz del Sur

Punta Arenas, Region of Magallanes, Chile

Outcomes

Primary Outcomes

Gait Deviation Index without assistance

Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.

Time frame: Baseline

Gait Deviation Index assisted by motorized ankle foot orthosis

Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.

Time frame: Day 1

Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology

Measured with QUEST scale. The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) is a 12-item outcome measure that assesses user satisfaction with two components, Device and Services. Scores of 1 indicate dissatisfaction and scores of 5 indicate high satisfaction

Time frame: Day 1

Data from ClinicalTrials.gov

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