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

NCT04249349 | Completed

• 1 other identifier: CorporacionRCLCS0003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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)

Conditions

Stroke

Keywords

Stroke; Ankle foot orthosis; Gait; Active orthosis

Outcome Measures

Primary Outcomes (3)

• Gait Deviation Index without assistance

  Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.

  Baseline

• Gait Deviation Index assisted by motorized ankle foot orthosis

  Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.

  Day 1

• Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology

  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

  Day 1

Study Arms (1)

Robot-assisted Gait

EXPERIMENTAL

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.

Device: Assisted gait with a motorized ankle foot orthosis

Interventions

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.

Robot-assisted Gait

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corporación de Rehabilitación Club de Leones Cruz del Sur: lead

Study Sites (1)

Corporación de Rehabilitación Club de Leones Cruz del Sur

Punta Arenas, Region of Magallanes, 6211525, Chile

Location

Related Publications (5)

• Pennycott A, Wyss D, Vallery H, Klamroth-Marganska V, Riener R. Towards more effective robotic gait training for stroke rehabilitation: a review. J Neuroeng Rehabil. 2012 Sep 7;9:65. doi: 10.1186/1743-0003-9-65.

  PMID: 22953989 BACKGROUND

• Nadeau S, Duclos C, Bouyer L, Richards CL. Guiding task-oriented gait training after stroke or spinal cord injury by means of a biomechanical gait analysis. Prog Brain Res. 2011;192:161-80. doi: 10.1016/B978-0-444-53355-5.00011-7.

  PMID: 21763525 BACKGROUND

• Belagaje SR. Stroke Rehabilitation. Continuum (Minneap Minn). 2017 Feb;23(1, Cerebrovascular Disease):238-253. doi: 10.1212/CON.0000000000000423.

  PMID: 28157752 BACKGROUND

• Shi B, Chen X, Yue Z, Yin S, Weng Q, Zhang X, Wang J, Wen W. Wearable Ankle Robots in Post-stroke Rehabilitation of Gait: A Systematic Review. Front Neurorobot. 2019 Aug 13;13:63. doi: 10.3389/fnbot.2019.00063. eCollection 2019.

  PMID: 31456681 BACKGROUND

• Young AJ, Ferris DP. State of the Art and Future Directions for Lower Limb Robotic Exoskeletons. IEEE Trans Neural Syst Rehabil Eng. 2017 Feb;25(2):171-182. doi: 10.1109/TNSRE.2016.2521160. Epub 2016 Jan 27.

  PMID: 26829794 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 30, 2020
• Study Start: September 27, 2019
• Primary Completion: November 4, 2019
• Study Completion: November 11, 2019
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)