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

Study Overview
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Brief Summary
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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)

Detailed Description
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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)

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

Conditions
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Stroke

Intervention / Treatment
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* Device: Assisted gait with a motorized ankle foot orthosis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot-assisted Gait<br>Participants will receive assisted gait with a motorized ankle foot orthosis. Patient´s gait will be analyzed by a photogrammetry system during device assistance. Session will involve 1 hour of supervised training. | Device: Assisted gait with a motorized ankle foot orthosis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Deviation Index without assistance | Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system. | 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. | 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 | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Ankle foot orthosis, Gait, Active orthosis