NCT04806100: MalleoLokStiff

Effects of Malleo-Lok Stiffness on Lower Limb Mechanics

Completed NA Results posted Last updated 15 June 2023

What this trial tests

NA trial testing Malleo-Lok in Adult ALL in 20 participants. Completed in 20 October 2021.

Timeline

11 March 2021

Primary endpoint
20 October 2021

20 October 2021

Quick facts

Lead sponsor	University of Iowa
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	20
Start date	11 March 2021
Primary completion	20 October 2021
Estimated completion	20 October 2021
Sites	1 location across United States

Drugs / interventions tested

• Malleo-Lok

Conditions studied

• Adult ALL — all drugs for Adult ALL →
• Healthy — all drugs for Healthy →

Sponsor

University of Iowa

Who can join

Adults 18 to 45, any sex, with Adult ALL or Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Ankle Joint Stiffness Primary · In-vivo ankle joint stiffness was measured for each condition before and after short bouts of walking (~15-20 minutes).

Ground reaction force and ankle motion data were collected simultaneously using the force measurement and motion capture systems as participants wore no brace (NoCDO), a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order. The ankle motion data was plotted against the ankle moment data and the slope of the corresponding line was the resulting ankle joint stiffness (Nm/degree).

Group	Value	95% CI
NoCDO	0.62	± 0.32
Compliant	0.97	± 0.34
Stiff	0.98	± 0.34

Ankle Joint Power Primary · Ankle joint power was measured for each condition during short bouts of walking (~15-20 minutes).

Peak ankle joint push-off power (W/kg) was calculated during gait and normalized to participant body weight as participants wore no brace (NoCDO), a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order.

Group	Value	95% CI
NoCDO	2.8	± 0.5
Compliant	2.2	± 0.4
Stiff	2.1	± 0.3

Ankle Joint Moment Primary · Ankle joint moment was measured for each condition during short bouts of walking (~15-20 minutes).

Peak ankle plantarflexion moment (Nm/kg) was calculated during gait and normalized to participant body weight as participants wore no brace (NoCDO), a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order.

Group	Value	95% CI
NoCDO	1.4	± 0.1
Compliant	1.3	± 0.1
Stiff	1.3	± 0.1

Numerical Pain Rating Scale Secondary · Participants were asked to rate their pain after completing in-vivo ankle stiffness testing and walking trials in all conditions.

Participants were asked to rate their pain on a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. Participants were asked to rate their pain after completing testing in no brace (NoCDO), a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order.

Group	Value	95% CI
NoCDO	0.1	± 0.2
Compliant	0.2	± 0.5
Stiff	0.2	± 0.5

Modified Socket Comfort Score: Comfort Secondary · Participants were asked to rate their comfort after completing in-vivo ankle stiffness testing and walking trials in Compliant and Stiff conditions.

Study participants were asked to rank the smoothness of each orthosis on a scale from 0-10 where 0 = least smooth and 10 = most smooth orthosis. Participants were asked to rate the comfort of each orthosis after completing testing in a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order.

Group	Value	95% CI
Compliant	7.5	± 1.7
Stiff	8.0	± 1.6

Modified Socket Comfort Score: Smoothness Secondary · Participants were asked to rate the orthosis smoothness after completing in-vivo ankle stiffness testing and walking trials in Compliant and Stiff conditions.

Study participants were asked to rank the smoothness of each orthosis on a scale from 0-10 where 0 = least smooth and 10 = most smooth orthosis. Participants were asked to rate the smoothness of each orthosis after completing testing in a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order.

Group	Value	95% CI
Compliant	7.8	± 1.7
Stiff	7.7	± 2.0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.