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Assistive Devices for Movement Disorders

N/A
Recruiting
Led By Adam Arabian, PhD
Research Sponsored by Orthocare Innovations, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has bilateral normal range of motion
Age 18 - 90 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collection immediately after acclimation with intervention
Awards & highlights

Study Summary

This trial is assessing how assistive technology affects people's ability to move in different settings. It looks at how people interact with different assistive technologies, and how these technologies can help people with limb weakness/paralysis/loss & movement disorders.

Who is the study for?
This trial is for adults aged 18-90 with limb weakness, paralysis, amputation, or movement disorders who can safely perform movements and use assistive devices like prosthetics and orthoses. They must be medically stable with good balance, able to walk on a treadmill if needed, communicate in English, and provide consent. Excluded are those with health issues that could affect participation or pregnant individuals.Check my eligibility
What is being tested?
The study evaluates how different assistive devices such as prosthetic ankles/knees/feet and ankle-foot orthoses impact human movement. Participants will engage in various activities including lab-based movement analysis, outdoor testing, usability assessments of the devices/components, and focus groups to discuss their experiences.See study design
What are the potential side effects?
Since this trial involves non-invasive procedures focused on assessing mobility aids rather than medical treatments or drugs, traditional side effects are not applicable. However participants may experience fatigue or discomfort from using the assistive devices during the tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can move all my joints normally.
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I am between 18 and 90 years old.
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I can walk by myself safely on a treadmill.
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I have a condition that affects my ability to move or use my limbs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collection at baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and collection at baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Walking Speed with intervention
Walking Speed with no intervention
Secondary outcome measures
Time to Complete Sit-to-Stand with intervention
Time to Complete Sit-to-Stand with no intervention
Timed Up and Go (TUG) Test
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Participant with interventionExperimental Treatment5 Interventions
Intervention refers to investigational assistive devices or commercially available assistive devices that individuals may use during this study.
Group II: Participant with normal assistive deviceActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Assist-Knee
2019
N/A
~10

Find a Location

Who is running the clinical trial?

Orthocare Innovations, LLCLead Sponsor
8 Previous Clinical Trials
174 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,697 Total Patients Enrolled
6 Trials studying Paralysis
299 Patients Enrolled for Paralysis
Adam Arabian, PhDPrincipal InvestigatorOrthocare Innovations, LLC

Media Library

Participant with intervention Clinical Trial Eligibility Overview. Trial Name: NCT05729061 — N/A
Paralysis Research Study Groups: Participant with intervention, Participant with normal assistive device
Paralysis Clinical Trial 2023: Participant with intervention Highlights & Side Effects. Trial Name: NCT05729061 — N/A
Participant with intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05729061 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of enrollment for this clinical research program?

"Affirmative. The clinical study, which was first posted on November 28th 2022 is still searching for participants according to information found on clinicaltrials.gov. It's presently looking for 100 volunteers at one location and was last updated on February 16th 2023."

Answered by AI

Is the minimum age requirement for participation in this trial 18 years or older?

"This study is open to people aged between 18 and 90, however there are other studies tailored specifically for those under the age of 18 (56 trials) or over 65 (84 trials)."

Answered by AI

What are the projected results of this investigation?

"Orthocare Innovations, LLC., the study sponsor for this research trial has outlined that Walking Speed will be its primary measurable outcome. Secondary metrics to evaluate include Time to Complete Sit-to-Stand with intervention, Timed Up and Go (TUG) Test, as well as a modified version of TUG accounting for participant's interaction with the proposed treatment. All assessments are undertaken using motion analysis systems and stopwatches in order to calculate average completion time with standard deviation."

Answered by AI

Are new participants still being welcomed into the clinical trial?

"Affirmative. Clinicaltrial.gov data suggests that this medical trial is currently seeking volunteers, which was first posted on November 28th 2022 and updated as recently as February 16th 2023. One hundred patients are being recruited from 1 location to participate in the study."

Answered by AI

What are the eligibility requirements to join this research program?

"This research project requires a sample size of 100 adults between 18 and 90 years old with amputations. The minimum eligibility criteria are as follows: age range, bilateral normal range-of-motion, informed consent, independent walking on treadmill (if applicable), capacity to carry out various movements, and proficiency in English for the purpose of expressing individual perceptions."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Analysis of Human Movement With Assistive Devices
2022. "Analysis of Human Movement With Assistive Devices". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05729061.
~29 spots leftby Nov 2024
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