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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Assisted gait with a motorized ankle foot orthosis

• Registration Number: NCT04249349
• Lead Sponsor: Corporación de Rehabilitación Club de Leones Cruz del Sur

Brief Summary

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

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 Timeline

• Study Start: 2019-09-27
• Primary Completion: 2019-11-04
• Study Completion: 2019-11-11
• Study First Submitted: 2020-01-29
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robot-assisted Gait	Assisted gait with a motorized ankle foot orthosis	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.

Primary Outcome Measures

Name	Time	Method
Gait Deviation Index without assistance	Baseline	Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Gait Deviation Index assisted by motorized ankle foot orthosis	Day 1	Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology	Day 1	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

Trial Locations

Locations (1)

Corporación de Rehabilitación Club de Leones Cruz del Sur; 🇨🇱 Punta Arenas, XII Región, Chile