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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04249349
Enrollment
10
Registered
2020-01-30
Start date
2019-09-27
Completion date
2019-11-11
Last updated
2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Ankle foot orthosis, Gait, Active orthosis

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)

Interventions

DEVICEAssisted gait with a motorized ankle foot orthosis

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.

Sponsors

Corporación de Rehabilitación Club de Leones Cruz del Sur
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Gait Deviation Index without assistanceBaselineGait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Gait Deviation Index assisted by motorized ankle foot orthosisDay 1Gait 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 TechnologyDay 1Measured 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

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026