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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Assisted gait with a motorized ankle foot orthosis
Sponsored by
Corporación de Rehabilitación Club de Leones Cruz del Sur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Ankle foot orthosis, Gait, Active orthosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Corporación de Rehabilitación Club de Leones Cruz del Sur

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Robot-assisted Gait

Arm 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.

Outcomes

Primary Outcome Measures

Gait Deviation Index without assistance
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
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
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

Secondary Outcome Measures

Full Information

First Posted
January 29, 2020
Last Updated
July 13, 2020
Sponsor
Corporación de Rehabilitación Club de Leones Cruz del Sur
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1. Study Identification

Unique Protocol Identification Number
NCT04249349
Brief Title
Preliminary Biomechanical and Usability Study of an Active Ankle-Foot Orthesis for Stroke Survivors
Official Title
Preliminary Biomechanical and Usability Study of an Active Ankle-Foot Orthesis for Stroke Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 27, 2019 (Actual)
Primary Completion Date
November 4, 2019 (Actual)
Study Completion Date
November 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corporación de Rehabilitación Club de Leones Cruz del Sur

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Ankle foot orthosis, Gait, Active orthosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot-assisted Gait
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Assisted gait with a motorized ankle foot orthosis
Intervention Description
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 Outcome Measure Information:
Title
Gait Deviation Index without assistance
Description
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Time Frame
Baseline
Title
Gait Deviation Index assisted by motorized ankle foot orthosis
Description
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Time Frame
Day 1
Title
Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology
Description
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
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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. Cancer Previous history or suspected seizures. Patient who does not sign the informed consent.
Facility Information:
Facility Name
Corporación de Rehabilitación Club de Leones Cruz del Sur
City
Punta Arenas
State/Province
XII Región
ZIP/Postal Code
6211525
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22953989
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.
Results Reference
background
PubMed Identifier
21763525
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.
Results Reference
background
PubMed Identifier
28157752
Citation
Belagaje SR. Stroke Rehabilitation. Continuum (Minneap Minn). 2017 Feb;23(1, Cerebrovascular Disease):238-253. doi: 10.1212/CON.0000000000000423.
Results Reference
background
PubMed Identifier
31456681
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.
Results Reference
background
PubMed Identifier
26829794
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.
Results Reference
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Preliminary Biomechanical and Usability Study of an Active Ankle-Foot Orthesis for Stroke Survivors

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