Analysis of Human Movement With Assistive Devices

NCT ID: NCT05729061

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-28

Study Completion Date

2024-11-28

Brief Summary

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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.

Detailed Description

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Conditions

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Limb Loss Limb Weakness Limb Paralysis Movement Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Participant with intervention

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

Group Type OTHER

Assist-Knee

Intervention Type DEVICE

Investigational prosthetic knee-ankle device

Prosthetic Knee

Intervention Type DEVICE

Commercially available prosthetic knee devices

Prosthetic Ankle

Intervention Type DEVICE

Commercially available prosthetic ankle devices

Prosthetic Foot

Intervention Type DEVICE

Commercially available prosthetic foot devices

Ankle-Foot Orthosis

Intervention Type DEVICE

Commercially available ankle-foot orthosis devices

Interventions

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Assist-Knee

Investigational prosthetic knee-ankle device

Intervention Type DEVICE

Prosthetic Knee

Commercially available prosthetic knee devices

Intervention Type DEVICE

Prosthetic Ankle

Commercially available prosthetic ankle devices

Intervention Type DEVICE

Prosthetic Foot

Commercially available prosthetic foot devices

Intervention Type DEVICE

Ankle-Foot Orthosis

Commercially available ankle-foot orthosis devices

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

* 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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Orthocare Innovations, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adam Arabian, PhD

Role: PRINCIPAL_INVESTIGATOR

Orthocare Innovations, LLC

Locations

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Orthocare Innovations, LLC

Edmonds, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Adam Arabian, PhD

Role: CONTACT

425-771-0797

Facility Contacts

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Adam Arabian, PhD

Role: primary

425-771-0797

Other Identifiers

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R44HD097826

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AD-001

Identifier Type: -

Identifier Source: org_study_id

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