Clinical trial NCT05729061: Analysis of Human Movement With Assistive Devices
Official title: Analysis of Human Movement With Assistive Devices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Limb Loss
Limb Weakness
Limb Paralysis
Movement Disorders
Lead sponsor: Orthocare Innovations, LLC
Sponsor class: INDUSTRY
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief 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 criteria: 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 outcomes:
measure: Walking Speed with no intervention
timeFrame: Collection at baseline
measure: Walking Speed with intervention
timeFrame: Collection immediately after acclimation with intervention
Secondary outcomes:
measure: Time to Complete Sit-to-Stand with no intervention
timeFrame: Collection at baseline
measure: Time to Complete Sit-to-Stand with intervention
timeFrame: Collection immediately after acclimation with intervention
measure: Timed Up and Go (TUG) Test
timeFrame: Collection at baseline
measure: Timed Up and Go (TUG) Test with intervention
timeFrame: Collected immediately after acclimation with intervention
Other outcomes:
Locations:
city: Edmonds
country: United States
facility: Orthocare Innovations, LLC
state: Washington
Study officials:
affiliation: Orthocare Innovations, LLC
name: Adam Arabian, PhD
role: PRINCIPAL_INVESTIGATOR
References: