Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The primary purpose of this research study is to determine if forces within carbon fiber custom dynamic orthoses (CDOs) can be reliability assessed using Loadpad and Loadsol force measuring sensors (Novel GMBH, St. Paul, MN). An improved understanding of the forces acting within orthoses may help to guide future orthosis related research studies, provision methods, and patient education. Study participants will consist of three groups; 1) healthy, able-bodied adult participants using generic sized CDOs, which consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that runs the length of the leg and bends to store and return energy, and a semi-rigid footplate that acts as a lever arm to bend the posterior strut, 2) individuals without peripheral neuropathy who use AFO(s) regularly, and 3) individuals with peripheral neuropathy who use AFO(s) regularly. . Group 1 participants will be asked to fasten the proximal cuff to a self-selected cuff tightness 'SSCT', as well as three different predefined force levels; 'Loose' where the proximal cuff is loosely fastened around the participants leg, 'Moderate' where the proximal cuff is fastened with moderate tightness, and 'Tight' where the proximal cuff is tightly fastened around the participants leg. Testing in the predetermined force levels (Loose, Moderate, Tight) will occur in a randomized order. Group 2 and Group 3 participants will be asked to fasten their AFO(s) to a self-selected 'SSCT' tightness. For all groups, forces acting on the leg, within the proximal cuff, will be measured using wireless Loadpad sensors and forces acting on the foot will be measured using wireless Loadsol insoles. Testing will include collection of force data as participants sit quietly, stand quietly, and walk and completion of questionnaires.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:

• Between the ages of 18 and 65

• Healthy without current complaint of lower extremity pain, spine pain, open wounds or active infections, or medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last 6 months

• Able to hop without pain

• Able to perform a full squat without pain

• Ability to read and write in English and provide written informed consent

• Ability to fit in a generic sized CDO

• Between the ages of 18 and 90

• Use an AFO(s) for daily activities

• The AFO(s) proximal cuff is compatible with loadpad sensors

• Have used their AFO(s) for a minimum of 2 weeks

• Ability to walk 50 feet without use of an assistive device (e.g. cane, crutch, etc.)

• Ability to read and write in English and provide written informed consent

• Between the ages of 18 and 90

• Use an AFO(s) for daily activities

• The AFO(s) proximal cuff is compatible with loadpad sensors

• Have used their AFO(s) for a minimum of 2 weeks

• Ability to walk 50 feet without use of an assistive device (e.g. cane, crutch, etc.)

• Diagnosis or indication of peripheral neuropathy determined using Semmes Weinstein Filaments

• Ability to read and write in English and provide written informed consent

Locations
United States
Iowa
University of Iowa
RECRUITING
Iowa City
Contact Information
Primary
Jason M Wilken, PT, PhD
jason-wilken@uiowa.edu
3193356857
Backup
Kirsten M Anderson, BSE
kirsten-m-anderson@uiowa.edu
3193530431
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 60
Treatments
No_intervention: NoCDO
Participants will complete study activities without wearing a CDO
Experimental: SSCT
Participants will complete study activities while wearing a CDO fastened to their self-selected proximal cuff tightness
Experimental: Loose
Participants will complete study activities while wearing a CDO fastened to a loose proximal cuff tightness
Experimental: Moderate
Participants will complete study activities while wearing a CDO fastened to a moderate proximal cuff tightness
Experimental: Tight
Participants will complete study activities while wearing a CDO fastened to a tight proximal cuff tightness
Related Therapeutic Areas
Sponsors
Leads: University of Iowa

This content was sourced from clinicaltrials.gov

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