Effects of Malleo-Lok Stiffness on Lower Limb Mechanics
(MalleoLokStiff Trial)

Recruiting in Palo Alto (17 mi)

Overseen byJason M Wilken, PT, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Iowa

No Placebo Group

Trial Summary

What is the purpose of this trial?The primary purpose of this research study is to determine if the stiffness of a commercially available ankle foot orthosis (Malleo-Lok, Bio-Mechanical Composites, Des Moines IA) impacts gait biomechanics and overall joint level stiffness. Previously published research suggests that AFO stiffness can affect gait biomechanics and patient preference. However, previous studies have focused on traditional posterior strut devices with the strut aligned in the frontal plane to allow sagittal plane deflection. The Malleo-Lok is a novel, low-profile carbon fiber device with two laterally positioned struts aligned in the sagittal plane. The proposed study will provide insight that can be used by certified prosthetists orthotists (CPOs), physical therapists, and physicians to select the device that bests meets their patients' needs.

Eligibility Criteria

Inclusion Criteria

You can jump without feeling any discomfort.

You can do a full squat without feeling any pain.

Between the ages of 18 and 45

+2 more

Exclusion Criteria

You have vision or hearing problems that have not been corrected with glasses or hearing aids.

You have a history of repeatedly spraining your ankle or having a weak and unstable ankle.

You have a physical or mental condition that would prevent you from taking functional tests (for example, heart disease, blood clotting disorder, or lung disease).

+7 more

Participant Groups

6Treatment groups

Experimental Treatment

Group I: Stiff, NoCDO, CompliantExperimental Treatment1 Intervention

Participants will be tested while wearing a stiff device (Stiff), then while wearing no brace (NoCDO), then while wearing a moderate stiffness device (Compliant).

Group II: Stiff, Compliant, NoCDOExperimental Treatment1 Intervention

Participants will be tested while wearing a stiff device (Stiff), then while wearing a moderate stiffness device (Compliant), then while wearing no brace (NoCDO).

Group III: NoCDO, Stiff, CompliantExperimental Treatment1 Intervention

Participants will be tested while wearing no brace (NoCDO), then while wearing a stiff device (Stiff), then while wearing a moderate stiffness device (Compliant).

Group IV: NoCDO, Compliant, StiffExperimental Treatment1 Intervention

Participants will be tested while wearing no brace (NoCDO), then a moderate stiffness device (Compliant), then while wearing a stiff device (Stiff).

Group V: Compliant, Stiff, NoCDOExperimental Treatment1 Intervention

Participants will be tested while wearing a moderate stiffness device (Compliant), then while wearing a stiff device (Stiff), then while wearing no brace (NoCDO).

Group VI: Compliant, NoCDO, StiffExperimental Treatment1 Intervention

Participants will be tested while wearing a moderate stiffness device (Compliant), then while wearing no brace (NoCDO), then while wearing a stiff device (Stiff).