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SSCT for Healthy Subjects (CuffForce Trial)

N/A
Recruiting
Led By Jason Anderson, PT,PhD
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

CuffForce Trial Summary

This trial aims to determine if forces in carbon fiber orthoses can be reliably measured using sensors. Participants will wear these orthoses and have different levels of tightness applied to them while sensors measure the forces

Who is the study for?
This trial is for healthy adults aged 18-65 with no lower extremity or spine pain, open wounds, infections, or disorders affecting work/exercise in the past 6 months. Participants must be able to hop and squat without pain and provide informed consent in English.Check my eligibility
What is being tested?
The study tests if sensors can reliably measure forces inside Carbon Fiber Custom Dynamic Orthoses (CDOs) on the leg. It involves using generic CDOs at different tightness levels while sitting, standing, walking, and completing questionnaires.See study design
What are the potential side effects?
Since this trial involves non-invasive testing with orthotic devices on healthy subjects rather than drug interventions, significant side effects are not anticipated.

CuffForce Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Modified Socket Comfort Score (Comfort)
Numerical Pain Rating Scale
Peak Plantar Force
+2 more
Secondary outcome measures
Modified Socket Comfort Score (Smoothness)

CuffForce Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: TightExperimental Treatment1 Intervention
Participants will complete study activities while wearing a CDO fastened to a tight proximal cuff tightness
Group II: SSCTExperimental Treatment1 Intervention
Participants will complete study activities while wearing a CDO fastened to their self-selected proximal cuff tightness
Group III: ModerateExperimental Treatment1 Intervention
Participants will complete study activities while wearing a CDO fastened to a moderate proximal cuff tightness
Group IV: LooseExperimental Treatment1 Intervention
Participants will complete study activities while wearing a CDO fastened to a loose proximal cuff tightness
Group V: NoCDOActive Control1 Intervention
Participants will complete study activities without wearing a CDO
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carbon Fiber Custom Dynamic Orthosis (CDO)
2021
N/A
~10

Find a Location

Who is running the clinical trial?

University of IowaLead Sponsor
449 Previous Clinical Trials
879,684 Total Patients Enrolled
Jason Anderson, PT,PhDPrincipal InvestigatorUniversity of Iowa

Frequently Asked Questions

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

Which individuals are eligible to participate in this research investigation?

"To be considered for participation in this study, individuals must be deemed healthy and fall within the 18 to 65 age range. The trial aims to enroll approximately 20 participants."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical study?

"Affirmative. Data on clinicaltrials.gov specifies that this research study is actively seeking participants. The trial was initially posted on March 1, 2024, and had its most recent update on April 2, 2024. Enrollment of approximately 20 patients will take place at a single designated site."

Answered by AI

Are patients currently being accepted to participate in this clinical trial?

"Affirmative. Information available on clinicaltrials.gov confirms the ongoing recruitment for this investigation. The trial was first listed on March 1st, 2024 and last revised on April 2nd, 2024. This study is seeking to enroll a total of 20 participants from one designated site."

Answered by AI

Is there an age limit for participation in this study, specifically with regards to individuals over the age of 45?

"Enrollment for this study is open to individuals over 18 years old but under the age of 65."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff
Jason Wilken 2024. "Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06127264.
~13 spots leftby Jan 2025
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