Testing an Adjustable Ankle Orthosis During Walking in Cerebral Palsy

March 21, 2024 updated by: Northern Arizona University

An Adjustable Stiffness Orthosis to Maintain Muscle Engagement and Push-off Power in Cerebral Palsy

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

Study Overview

Status

Recruiting

Conditions

Detailed Description

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

Enrollment (Estimated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Flagstaff, Arizona, United States, 86011
        • Recruiting
        • Northern Arizona University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Participants will walk with the new AFO, their own AFOs, and no AFOs.
Walking with a differential and adjustable stiffness AFO (DAS-AFO)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle activity
Time Frame: day 1
Mean plantar flexor muscle activity during stance phase
day 1
Metabolic cost of transport
Time Frame: day 1
Metabolic cost of transport during walking
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pictorial Children's Effort Rating Table (PCERT)
Time Frame: day 1
Pictorial Children's Effort Rating Table (PCERT) score (Range: 0:10; higher score means higher exertion)
day 1
System Usability Score (SUS) questionnaire
Time Frame: day 1
System Usability Scale Score (Range: 0:100; higher score means better usability)
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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