Testing an Adjustable Ankle Orthosis During Walking in Cerebral Palsy

NCT06262191 | Completed Early Phase 1 Results FDA Device

• 1 other identifier: 2137249
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (3)

• Change in Muscle Activity

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

  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.

  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.

  1 day during walking

Study Arms (1)

Study group

EXPERIMENTAL

Participants will walk with the new AFO, their own AFOs, and no AFOs.

Device: Differential and adjustable stiffness AFO (DAS-AFO)

Interventions

Differential and adjustable stiffness AFO (DAS-AFO) DEVICE

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

Study group

Eligibility Criteria

• Age: 8 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Excessive knee flexion during walking caused by CP

Sponsors & Collaborators

• Northern Arizona University: lead

Study Sites (1)

Northern Arizona University

Flagstaff, Arizona, 86011, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: PI
• Organization: Northern Arizona University

zachary.lerner@nau.edu

928-523-1787

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 15, 2024
• Study Start: May 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 25, 2025
• Results First Posted: May 25, 2025

Record last verified: 2025-05

Locations

US (1)