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OpenTrials
Completed

NCT Number: NCT04249349

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

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)

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Corporación de Rehabilitación Club de Leones Cruz del Sur

Punta Arenas, Region of Magallanes, 6211525, Chile

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Assisted gait with a motorized ankle foot orthosis

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Corporación de Rehabilitación Club de Leones Cruz del Sur

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2020
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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