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Recruiting NCT05729061

Analysis of Human Movement With Assistive Devices

No phase Interventional Limb Loss Limb Weakness Limb Paralysis Movement Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Assist-Knee, Prosthetic Knee, Prosthetic Ankle, Prosthetic Foot.
Who it may be relevant to
Registry conditions: Limb Loss, Limb Weakness, Limb Paralysis, Movement Disorders. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Walking Speed with no intervention [Time frame: Collection at baseline]
  • Walking Speed with intervention [Time frame: Collection immediately after acclimation with intervention]
Secondary outcome measures (4)
  • Time to Complete Sit-to-Stand with no intervention [Time frame: Collection at baseline]
  • Time to Complete Sit-to-Stand with intervention [Time frame: Collection immediately after acclimation with intervention]
  • Timed Up and Go (TUG) Test [Time frame: Collection at baseline]
  • Timed Up and Go (TUG) Test with intervention [Time frame: Collected immediately after acclimation with intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Orthocare Innovations, LLC — Edmonds

Identifiers

NCT: NCT05729061 · AD-001 · R44HD097826

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗