Analysis of Human Movement With Assistive Devices

NCT05729061 | Recruiting FDA Device

• 2 other identifiers: AD-001R44HD097826
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Limb Loss; Limb Weakness; Limb Paralysis; Movement Disorders

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Time to Complete Sit-to-Stand with no intervention

  Collection at baseline

• Time to Complete Sit-to-Stand with intervention

  Collection immediately after acclimation with intervention

• Timed Up and Go (TUG) Test

  Collection at baseline

• Timed Up and Go (TUG) Test with intervention

  Collected immediately after acclimation with intervention

Study Arms (2)

Participant with normal assistive device

NO INTERVENTION

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.

Participant with intervention

OTHER

Intervention refers to investigational assistive devices or commercially available assistive devices that individuals may use during this study.

Device: Assist-Knee; Device: Prosthetic Knee; Device: Prosthetic Ankle; Device: Prosthetic Foot; Device: Ankle-Foot Orthosis

Interventions

Assist-Knee DEVICE

Investigational prosthetic knee-ankle device

Participant with intervention

Prosthetic Knee DEVICE

Commercially available prosthetic knee devices

Participant with intervention

Prosthetic Ankle DEVICE

Commercially available prosthetic ankle devices

Participant with intervention

Prosthetic Foot DEVICE

Commercially available prosthetic foot devices

Participant with intervention

Ankle-Foot Orthosis DEVICE

Commercially available ankle-foot orthosis devices

Participant with intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Orthocare Innovations, LLC: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Orthocare Innovations, LLC

Edmonds, Washington, 98020, United States

RECRUITING

MeSH Terms

Conditions

Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Adam Arabian, PhD

  Orthocare Innovations, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Arabian, PhD

CONTACT

425-771-0797; arabian@orthocareinnovations.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: February 15, 2023
• Study Start: November 28, 2022
• Primary Completion: November 28, 2024
• Study Completion: November 28, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)