Health TrialsbyHealthPanel

Analysis of Human Movement With Assistive Devices

ConditionsLimb LossLimb WeaknessLimb ParalysisMovement Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorOrthocare Innovations, LLC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Age 18 - 90 years

Trial design

Design model

Sequential

Treatments tested in this trial

  • Assist-Knee

    Device

    Investigational prosthetic knee-ankle device

  • Prosthetic Knee

    Device

    Commercially available prosthetic knee devices

  • Prosthetic Ankle

    Device

    Commercially available prosthetic ankle devices

  • Prosthetic Foot

    Device

    Commercially available prosthetic foot devices

  • Ankle-Foot Orthosis

    Device

    Commercially available ankle-foot orthosis devices

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Participant with normal assistive deviceNo intervention 0 interventions
Group B: Participant with interventionOther 5 interventions

Trial outcomes

Primary outcomes

1

Walking Speed with no intervention

Walking speed determined over 8 meters of walking

Time frame
Collection at baseline
2

Walking Speed with intervention

Walking speed calculated over 8 meters of walking

Time frame
Collection immediately after acclimation with intervention

Secondary outcomes

1

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
2

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.

Time frame
Collection immediately after acclimation with intervention
3

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
4

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.

Time frame
Collected immediately after acclimation with intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Orthocare Innovations, LLC

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
Apply now