Analysis of Human Movement With Assistive Devices

Orthocare Innovations, LLC100 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

100

Conditions

Limb Loss Limb Weakness

Interventions

Assist-KneeDEVICE

Investigational prosthetic knee-ankle device

Prosthetic KneeDEVICE

Commercially available prosthetic knee devices

Prosthetic AnkleDEVICE

Commercially available prosthetic ankle devices

Prosthetic FootDEVICE

Commercially available prosthetic foot devices

Ankle-Foot OrthosisDEVICE

Commercially available ankle-foot orthosis devices

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Walking Speed with no intervention

Walking speed determined over 8 meters of walking

Time frame: Collection at baseline

Walking Speed with intervention

Walking speed calculated over 8 meters of walking

Time frame: Collection immediately after acclimation with intervention

Secondary Outcomes

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.

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

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.

Time frame: Collection at baseline

Timed Up and Go (TUG) Test with intervention

Time frame: Collected immediately after acclimation with intervention

Analysis of Human Movement With Assistive Devices

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts