Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Iowa

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Diagnosed with a moderate or severe brain injury

Lower extremity injury resulting in surgery or limiting function for greater than 6 weeks

Injuries that would limit performance in this study

Diagnosed with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Carbon Fiber Custom Dynamic Orthosis (CDO)

    Device

    The carbon fiber custom dynamic orthosis (CDO) will consist of a semi-rigid carbon fiber footplate, a carbon fiber posterior strut, and a proximal cuff that wraps around the leg below the knee that is fastened to different tightness's

Treatment groups

60 Participants
are divided into 5 treatment groups
Group A: NoCDONo intervention 0 interventions
Group B: SSCTExperimental treatment 1 intervention
Group C: LooseExperimental treatment 1 intervention
Group D: ModerateExperimental treatment 1 intervention
Group E: TightExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proximal Cuff Force

Proximal cuff forces (N) will be measured as participants sit, stand, and walk without a CDO and in each CDO condition.

Time frame
Baseline
2

Peak Plantar Force

Plantar forces (N) will be measured across the total foot, the hindfoot, midfoot, and forefoot as participants sit, stand, and walk without a CDO and in each CDO condition.

Time frame
Baseline
3

Plantar Force Impulse

Plantar force impulse (Ns) across the total foot, the hindfoot, midfoot, and forefoot will be calculated using the integral of the force over the stance phase as participants sit, stand, and walk without a CDO and in each CDO condition.

Time frame
Baseline
4

Numerical Pain Rating Scale

Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable

Time frame
Baseline

Secondary outcomes

1

Modified Socket Comfort Score (Smoothness)

Smoothness scores range from 0 = least smooth to 10 = most smooth

Time frame
Baseline

Other outcomes

Sponsors and contacts

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