Clinical trial NCT04249349: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Ankle foot orthosis
Gait
Active orthosis
Lead sponsor: Corporación de Rehabilitación Club de Leones Cruz del Sur
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: Gait Deviation Index without assistance
timeFrame: Baseline
measure: Gait Deviation Index assisted by motorized ankle foot orthosis
timeFrame: Day 1
measure: Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Punta Arenas
country: Chile
facility: Corporación de Rehabilitación Club de Leones Cruz del Sur
state: XII Región
Study officials:
References:
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.
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.
citation: Belagaje SR. Stroke Rehabilitation. Continuum (Minneap Minn). 2017 Feb;23(1, Cerebrovascular Disease):238-253. doi: 10.1212/CON.0000000000000423.
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.
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.