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

Corporación de Rehabilitación Club de Leones Cruz del Sur

Status: Completed

Conditions: Stroke

Treatments: Device: Assisted gait with a motorized ankle foot orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT04249349

CorporacionRCLCS0003

Details and patient eligibility

About

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)

Full 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)

Enrollment: 10 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Robot-assisted Gait

Experimental group

Description:

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.

Treatment:

Device: Assisted gait with a motorized ankle foot orthosis