Analysis of Human Movement With Assistive Devices

Orthocare Innovations

Status

Enrolling

Conditions

Limb Paralysis

Limb Loss

Movement Disorders

Limb Weakness

Treatments

Device: Ankle-Foot Orthosis

Device: Prosthetic Ankle

Device: Prosthetic Knee

Device: Assist-Knee

Device: Prosthetic Foot

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT05729061

R44HD097826 (U.S. NIH Grant/Contract)

AD-001

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Participant with normal assistive device

No Intervention group

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.

Participant with intervention

Other group