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Clinical Trials in the USA / NCT05729061
Recruiting Not applicable

Analysis of Human Movement With Assistive Devices

NCT05729061 · tracked via the Priya Life Science USA tracker
Sponsor
Orthocare Innovations, LLC
Phase
Not applicable
Started
2022-11-28
Last updated
2023-10-10

Condition(s) studied

Limb LossLimb WeaknessLimb ParalysisMovement Disorders

Investigational drug(s) / intervention(s)

Assist-KneeProsthetic KneeProsthetic AnkleProsthetic FootAnkle-Foot Orthosis

Assist-Knee: Investigational prosthetic knee-ankle device

Prosthetic Knee: Commercially available prosthetic knee devices

Prosthetic Ankle: Commercially available prosthetic ankle devices

Prosthetic Foot: Commercially available prosthetic foot devices

Ankle-Foot Orthosis: Commercially available ankle-foot orthosis devices

Study summary

The purpose of this research is to evaluate how people move about in different settings with different assistive devices or components, and to understand how people interact with different assistive technologies. Individuals that have limb weakness, limb paralysis, limb loss, and movement disorders are often provided assistive devices such as prostheses and orthoses to assist with mobility or use assistive technologies for purposes such as to regain muscle strength or retrain movements. It is important to understand the impact of these different assistive technologies on human movement for technology improvement and in preparation for commercialization.

Because this research focuses on evaluating how different people move about in different settings with different assistive devices/components, there are different activities that may take place. These activities have been classified as (1) Movement Analysis in the Laboratory, (2) Movement Analysis Outside the Laboratory, (3) Usability Testing, and (4) Focus Groups. Each participant may or may not complete the same activities as the other participants. Each participant may or may not complete all of the activities. Participants may complete the activities more than once.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
Accepted
Inclusion Criteria for Nondisabled Participants: * Age 18 - 90 years * Has bilateral normal range of motion * Able to perform a variety of movement activities * Able to communicate and write individual perceptions in English * Able to provide written informed consent * Participants that will use a treadmill during data collection must also be able to walk independently and safely on a treadmill Exclusion Criteria for Nondisabled Participants: * Health issues (e.g., confounding injury, musculoskeletal, or cognitive) or other issues (e.g., transportation or schedule issues) that limit effective participation and/or may not represent a nondisabled condition * Pregnancy * Not able to read and understand English Inclusion Criteria for Participants with a Disability: * Age 18 - 90 years * Has a condition or diagnosis that results in limb weakness, limb paralysis, limb loss, or movement disorders * Medically stable * Has stable balance * Able to perform a variety of movement activities * Able to communicate and write individual perceptions in English * Able to provide written informed consent * Participants that will use a treadmill during data collection must also be able to walk independently and safely on a treadmill * Able to safely complete the movements being tested and/or safely use the assistive devices being tested Exclusion Criteria for Participants with a Disability: * Health issues (e.g., confounding injury, musculoskeletal, or cognitive) or other issues (e.g., transportation or schedule issues) that limit effective participation and/or may result in mixed effects of multiple sources of disability * Pregnancy * Not able to read and understand English

Primary outcome measure(s)

  • Walking Speed with no intervention — Collection at baseline
    Walking speed determined over 8 meters of walking
  • Walking Speed with intervention — Collection immediately after acclimation with intervention
    Walking speed calculated over 8 meters of walking

Trial sites (1)

FacilityCityRegionStatus
Orthocare Innovations, LLC Edmonds Washington Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05729061 on ClinicalTrials.gov ↗ ← All trials in the USA