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Analysis of Human Movement With Assistive Devices

Primary Purpose

Limb Loss, Limb Weakness, Limb Paralysis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Assist-Knee
Prosthetic Knee
Prosthetic Ankle
Prosthetic Foot
Ankle-Foot Orthosis
Sponsored by
Orthocare Innovations, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Limb Loss

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Orthocare Innovations, LLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Participant with normal assistive device

Participant with intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Walking Speed with no intervention
Walking speed determined over 8 meters of walking
Walking Speed with intervention
Walking speed calculated over 8 meters of walking

Secondary Outcome Measures

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 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.
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.
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.

Full Information

First Posted
January 5, 2023
Last Updated
October 6, 2023
Sponsor
Orthocare Innovations, LLC
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05729061
Brief Title
Analysis of Human Movement With Assistive Devices
Official Title
Analysis of Human Movement With Assistive Devices
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 28, 2022 (Actual)
Primary Completion Date
November 28, 2024 (Anticipated)
Study Completion Date
November 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orthocare Innovations, LLC
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Limb Loss, Limb Weakness, Limb Paralysis, Movement Disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participant with normal assistive device
Arm Type
No Intervention
Arm Description
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.
Arm Title
Participant with intervention
Arm Type
Other
Arm Description
Intervention refers to investigational assistive devices or commercially available assistive devices that individuals may use during this study.
Intervention Type
Device
Intervention Name(s)
Assist-Knee
Intervention Description
Investigational prosthetic knee-ankle device
Intervention Type
Device
Intervention Name(s)
Prosthetic Knee
Intervention Description
Commercially available prosthetic knee devices
Intervention Type
Device
Intervention Name(s)
Prosthetic Ankle
Intervention Description
Commercially available prosthetic ankle devices
Intervention Type
Device
Intervention Name(s)
Prosthetic Foot
Intervention Description
Commercially available prosthetic foot devices
Intervention Type
Device
Intervention Name(s)
Ankle-Foot Orthosis
Intervention Description
Commercially available ankle-foot orthosis devices
Primary Outcome Measure Information:
Title
Walking Speed with no intervention
Description
Walking speed determined over 8 meters of walking
Time Frame
Collection at baseline
Title
Walking Speed with intervention
Description
Walking speed calculated over 8 meters of walking
Time Frame
Collection immediately after acclimation with intervention
Secondary Outcome Measure Information:
Title
Time to Complete Sit-to-Stand with no intervention
Description
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
Title
Time to Complete Sit-to-Stand with intervention
Description
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 immediately after acclimation with intervention
Title
Timed Up and Go (TUG) Test
Description
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
Title
Timed Up and Go (TUG) Test with intervention
Description
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
Collected immediately after acclimation with intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Arabian, PhD
Phone
425-771-0797
Email
arabian@orthocareinnovations.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Arabian, PhD
Organizational Affiliation
Orthocare Innovations, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthocare Innovations, LLC
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Arabian, PhD
Phone
425-771-0797
Email
arabian@orthocareinnovations.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Analysis of Human Movement With Assistive Devices

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