Testing an Adjustable Ankle Orthosis During Walking in Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06262191
• Other study ID #: 2137249
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: May 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2024
• Source: Northern Arizona University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• Differential and adjustable stiffness AFO (DAS-AFO)
Walking with a differential and adjustable stiffness AFO (DAS-AFO)

Locations

Country	Name	City	State
United States	Northern Arizona University	Flagstaff	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Northern Arizona University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle activity	Mean plantar flexor muscle activity during stance phase	day 1
Primary	Metabolic cost of transport	Metabolic cost of transport during walking	day 1
Secondary	Pictorial Children's Effort Rating Table (PCERT)	Pictorial Children's Effort Rating Table (PCERT) score (Range: 0:10; higher score means higher exertion)	day 1
Secondary	System Usability Score (SUS) questionnaire	System Usability Scale Score (Range: 0:100; higher score means better usability)	day 1