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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04249349
• Other study ID #: CorporacionRCLCS0003
• Status: Completed
• Phase: N/A
• Start date: September 27, 2019
• Est. completion date: November 11, 2019

Study information

• Verified date: July 2020
• Source: Corporación de Rehabilitación Club de Leones Cruz del Sur
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 11, 2019
• Est. primary completion date: November 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Assisted 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.

Locations

Country	Name	City	State
Chile	Corporación de Rehabilitación Club de Leones Cruz del Sur	Punta Arenas	XII Región

Sponsors (1)

Lead Sponsor	Collaborator
Corporación de Rehabilitación Club de Leones Cruz del Sur

Country where clinical trial is conducted

Chile, 

References & Publications (5)

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

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait Deviation Index without assistance	Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.	Baseline
Primary	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
Primary	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