Augmenting Ankle Plantarflexor Function and Walking Capacity in Children With Cerebral Palsy

Who is this study for? Patients with Cerebral Palsy
Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The first specific aim is to quantify improvement in ankle muscle function and functional mobility following targeted ankle resistance gait training in ambulatory children with cerebral palsy (CP). The primary hypothesis for the first aim is that targeted ankle resistance training will produce larger improvements in lower-extremity motor control, gait mechanics, and clinical measures of mobility assessed four- and twelve-weeks post intervention compared to standard physical therapy and standard gait training. The second specific aim is to determine the efficacy of adaptive ankle assistance to improve capacity and performance during sustained, high-intensity, and challenging tasks in ambulatory children with CP. The primary hypothesis for the second aim is that adaptive ankle assistance will result in significantly greater capacity and performance during the six-minute-walk-test and graded treadmill and stair stepping protocols compared to walking with ankle foot orthoses and walking with just shoes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 21
Healthy Volunteers: f
View:

• Ages between 8 and 21 years old, inclusive. Diagnosis of CP and a pathological gait pattern caused by ankle dysfunction.

• Able to understand and follow simple directions (based on parent report, if needed) and walk at least 30 feet with or without a walking aid (Gross Motor Function Classification System (GMFCS) Level I-III).

• At least 20° of passive plantar-flexion range of motion.

Locations
United States
Minnesota
Gillette Children's Specialty Healthcare
RECRUITING
Minneapolis
Contact Information
Primary
Zach Lerner, PhD
zachary.lerner@nau.edu
928-523-1787
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2026-09-25
Participants
Target number of participants: 36
Treatments
Experimental: Device resisted gait training (treatment)
We will conduct a randomized controlled trial (treatment vs. control) to compare functional outcomes following bilateral targeted ankle resistance training (2 visits/week for 12 weeks) vs. dose-matched standard functional gait training.
Experimental: Standard gait training (control)
We will conduct a randomized controlled trial (treatment vs. control) to compare functional outcomes following bilateral targeted ankle resistance training (2 visits/week for 12 weeks) vs. dose-matched standard functional gait training.
Experimental: Comparison to Standard PT (within subjects control)
We will use a within-subject repeated measures design to compare both gait training groups to matched standard physical therapy.
Experimental: Device assisted ambulation
We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).
Experimental: Passive brace assisted ambulation
We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).
Experimental: No ankle aid ambulation
We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).
Related Therapeutic Areas
Sponsors
Collaborators: University of Washington, Gillette Children's Specialty Healthcare
Leads: Northern Arizona University

This content was sourced from clinicaltrials.gov