Testing an Adjustable Ankle Orthosis During Walking in Cerebral Palsy

Early Phase 1CompletedNCT06262191

Northern Arizona University11 enrolled

Overview

This study seeks to determine how an adjustable stiffness ankle braces affects walking performance and biomechanics in cerebral palsy.

Our first aim is to confirm that the differential and adjustable stiffness (DAS) AFO improves plantarflexor push-off power and range of motion compared to standard (physician prescribed) AFOs during walking in CP. Our second aim is to confirm that the differential and adjustable stiffness (DAS) AFO improves plantarflexor muscle activity while maintaining improved posture compared to standard AFOs during walking in CP. Our third aim is to validate the need and usability of real-time stiffness adjustment during play and school activities; obtain feedback from the children, their parents, and orthotists to design the MVP.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cerebral Palsy

Interventions

Differential and adjustable stiffness AFO (DAS-AFO)DEVICE

Walking with a differential and adjustable stiffness AFO (DAS-AFO)

Eligibility

Sex: ALLMin age: 8 YearsMax age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 8-35 years old, inclusive * Diagnosis of cerebral palsy (CP) * Gross motor functional classification score level I, II, or III * Physician-prescribed AFOs of common design (i.e., rigid molded thermoplastic) * Ability to walk for 6 minutes on a treadmill * At least 20° of passive plantar-flexion range of motion * No concurrent treatment other than those assigned during the study * No condition other than CP that would affect safe participation * No surgery within 6 months of participation. Exclusion Criteria: -Excessive knee flexion during walking caused by CP

Locations (1)

Northern Arizona University

Flagstaff, Arizona, United States

Outcomes

Primary Outcomes

Change in Muscle Activity

Change in integrated soleus electromyography (mV/mV) muscle activity during stance phase of walking.

Time frame: day 1

Change in Metabolic Cost of Transport

Change in metabolic cost of transport during walking. To calculate the metabolic cost of transport, the standing baseline metabolic rate for each participant and each trial was subtracted from their walking metabolic rate to estimate the net metabolic rate of walking. Next, we normalized the net metabolic rate of walking by each participant's body mass (m) and walking speed to calculate the metabolic cost of transport (J/kg\*m), averaged over the last two minutes of each condition.

Time frame: day 1

Change in Ankle Power

Change in peak ankle power during stance phase measured in w/kg. Ankle kinematics and kinetics were calculated in OpenSim using the collected three-dimensional motion capture and the ground reaction forces. The joint kinematics and ground reaction forces were filtered using a low pass fourth order recursive Butterworth filter with a cut-off frequency of 6 Hz before being used to calculate joint kinetics. The ground reaction forces were collected using two force places associated with the instrumented treadmill (Bertec Corp, Columbus, USA) collected at 1200 Hz. The resultant joint kinetics were then further filtered using the same filtering parameters. Ankle joint power was calculated as the product of the joint moment and joint angular velocity.

Time frame: 1 day during walking

Data from ClinicalTrials.gov

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