- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06262191
Testing an Adjustable Ankle Orthosis During Walking in Cerebral Palsy
An Adjustable Stiffness Orthosis to Maintain Muscle Engagement and Push-off Power in Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Arizona
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Flagstaff, Arizona, United States, 86011
- Recruiting
- Northern Arizona University
-
Contact:
- Zach Lerner, PhD
- Phone Number: 928-523-1787
- Email: zachary.lerner@nau.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2137249
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Cerebral Palsy
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-
Northwestern UniversityActive, not recruitingCerebral Palsy | Diplegic Cerebral Palsy | Bilateral Cerebral PalsyUnited States
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Centre Médico-Chirurgical de Réadaptation des Massues...RecruitingCerebral Palsy, Dyskinetic | Cerebral Palsy, Spastic | Infantile Hemiplegic Cerebral PalsyFrance
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Hilde FeysHasselt University; ETH Zurich; Curtin UniversityRecruitingHemiplegic Cerebral Palsy | Cerebral Palsy, SpasticBelgium
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University of California, San FranciscoNational Institutes of Health (NIH)RecruitingDystonic Cerebral Palsy | Dyskinetic Cerebral PalsyUnited States
-
MTI UniversityEnrolling by invitationSpastic Diplegic Cerebral PalsyEgypt
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East Carolina UniversityRecruitingHemiplegic Cerebral Palsy | Unilateral Cerebral Palsy | Remote Ischemic ConditioningUnited States
-
October 6 UniversityCompletedSpastic Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyEgypt
-
Marmara UniversityUnknownCerebral Palsy, Spastic | Cerebral Palsy, Spastic, DiplegicTurkey
Clinical Trials on Differential and adjustable stiffness AFO (DAS-AFO)
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Texas Woman's UniversityBaylor Research InstituteCompletedStroke | Hemiplegia | Hemiparesis | Foot Drop | CVAUnited States
-
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-
Jason WilkenMinneapolis Veterans Affairs Medical Center; Johns Hopkins Bloomberg School... and other collaboratorsCompleted
-
Danderyd HospitalKTH Royal Institute of TechnologyRecruitingStroke | Hemiplegia | Ambulation DifficultySweden
-
University of MinnesotaNational Institutes of Health (NIH); National Institute of General Medical...Completed
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Gitte KronborgRigshospitalet, Denmark; Hvidovre University Hospital; Statens Serum Institut; Ministry...Completed
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Statens Serum InstitutEuropean and Developing Countries Clinical Trials Partnership (EDCTP); Ministry...CompletedAids, Cdc Group IGuinea-Bissau
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University of IowaBio-Mechanical CompositesRecruitingHealthy | Lower Limb Injury | Post-Traumatic OsteoarthritisUnited States
-
University of IowaWithdrawnPost-traumatic Osteoarthritis | Ankle Fractures | Osteoarthritis AnkleUnited States
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University of Texas Southwestern Medical CenterAmerican Orthotic and Prosthetic AssociationCompletedParkinson Disease | Gait Disorders, NeurologicUnited States