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.

Study Overview

• Status: Recruiting
• Conditions: Movement Disorders; Limb Loss; Limb Weakness; Limb Paralysis
• Intervention / Treatment: Device: Assist-Knee; Device: Prosthetic Knee; Device: Prosthetic Ankle; Device: Prosthetic Foot; Device: Ankle-Foot Orthosis

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam Arabian, PhD; Phone Number: 425-771-0797; Email: arabian@orthocareinnovations.com

Study Locations

• United States
  • Washington
    • Edmonds, Washington, United States, 98020
      • Recruiting
      • Orthocare Innovations, LLC
      • Contact: Adam Arabian, PhD; Phone Number: 425-771-0797; Email: arabian@orthocareinnovations.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Participant with normal assistive device; Normal assistive device refers to the habitual assistive device that may be prescribed by a provider of care or no assistive device if the individual does not normally use.
Other: Participant with intervention; Intervention refers to investigational assistive devices or commercially available assistive devices that individuals may use during this study.	Device: Assist-Knee; Investigational prosthetic knee-ankle device; Device: Prosthetic Knee; Commercially available prosthetic knee devices; Device: Prosthetic Ankle; Commercially available prosthetic ankle devices; Device: Prosthetic Foot; Commercially available prosthetic foot devices; Device: Ankle-Foot Orthosis; Commercially available ankle-foot orthosis devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking Speed with no intervention	Walking speed determined over 8 meters of walking	Collection at baseline
Walking Speed with intervention	Walking speed calculated over 8 meters of walking	Collection immediately after acclimation with intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Complete Sit-to-Stand with no 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.	Collection at baseline
Timed Up and Go (TUG) Test	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.	Collection at baseline
Timed Up and Go (TUG) Test 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.	Collected immediately after acclimation with intervention
Time to Complete Sit-to-Stand 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.	Collection immediately after acclimation with intervention

Collaborators and Investigators

• Sponsor: Orthocare Innovations, LLC
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Adam Arabian, PhD, Orthocare Innovations, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2022
• Primary Completion (Estimated): November 28, 2024
• Study Completion (Estimated): November 28, 2024

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Paralysis; Movement Disorders
• Other Study ID Numbers: AD-001; R44HD097826 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes