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Clinical Trials/NCT04249349
NCT04249349
Completed
Not Applicable

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

Corporación de Rehabilitación Club de Leones Cruz del Sur1 site in 1 country10 target enrollmentSeptember 27, 2019
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Corporación de Rehabilitación Club de Leones Cruz del Sur
Enrollment
10
Locations
1
Primary Endpoint
Gait Deviation Index without assistance
Status
Completed
Last Updated
5 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
September 27, 2019
End Date
November 11, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Corporación de Rehabilitación Club de Leones Cruz del Sur
Responsible Party
Sponsor

Eligibility Criteria

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.
  • Previous history or suspected seizures.
  • Patient who does not sign the informed consent.

Outcomes

Primary Outcomes

Gait Deviation Index without assistance

Time Frame: 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

Time Frame: 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

Time Frame: 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

Study Sites (1)

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