Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05729061

Analysis of Human Movement With Assistive Devices

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Limb Loss Central Nervous System Diseases Limb Paralysis Limb Weakness Movement Disorders Nervous System Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthocare Innovations, LLC

Edmonds, Washington, 98020, United States

Location status: Recruiting

Location contact

Adam Arabian, PhD

CONTACT

[email protected]

425-771-0797

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assist-Knee

Device

Investigational prosthetic knee-ankle device

Prosthetic Knee

Device

Commercially available prosthetic knee devices

Prosthetic Ankle

Device

Commercially available prosthetic ankle devices

Prosthetic Foot

Device

Commercially available prosthetic foot devices

Ankle-Foot Orthosis

Device

Commercially available ankle-foot orthosis devices

Primary outcomes

  1. Walking Speed with no intervention

    Time frame: Collection at baseline

    Walking speed determined over 8 meters of walking

  2. Walking Speed with intervention

    Time frame: Collection immediately after acclimation with intervention

    Walking speed calculated over 8 meters of walking

Secondary outcomes

  1. Time to Complete Sit-to-Stand with no intervention

    Time frame: Collection at baseline

    The amount of time, measured in seconds, needed by the subject to complete the sit-to-stand transition. At least three trials of the sit-to-stand maneuver are collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the sit-to-stand transition are calculated for each participant. The start of the transition will be determined by participant initiation; the end of the transition will be determined by the participant reaching full knee extension.

  2. Time to Complete Sit-to-Stand with intervention

    Time frame: Collection immediately after acclimation with intervention

    The amount of time, measured in seconds, needed by the subject to complete the sit-to-stand transition. At least three trials of the sit-to-stand maneuver are collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the sit-to-stand transition are calculated for each participant. The start of the transition will be determined by participant initiation; the end of the transition will be determined by the participant reaching full knee extension.

  3. Timed Up and Go (TUG) Test

    Time frame: Collection at baseline

    The Timed Up and Go (TUG) test is a validated timed functional test that involves standing up from a chair, walking forward for 3 meters, turning around, walking back to the chair for 3 meter, and sitting down. Each participant will complete the TUG test for three trials. Time is measured using a stopwatch. Average and standard deviation of the time to complete the TUG test are calculated for each participant.

  4. Timed Up and Go (TUG) Test with intervention

    Time frame: Collected immediately after acclimation with intervention

    The Timed Up and Go (TUG) test is a validated timed functional test that involves standing up from a chair, walking forward for 3 meters, turning around, walking back to the chair for 3 meter, and sitting down. Each participant will complete the TUG test for three trials. Time is measured using a stopwatch. Average and standard deviation of the time to complete the TUG test are calculated for each participant.

Study contacts

Contact information is provided by the study sponsor or research team.

Adam Arabian, PhD

CONTACT

[email protected]

425-771-0797

Sponsors and collaborators

Lead sponsor

Orthocare Innovations, LLC

Industry

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 15, 2023
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.