Status:
COMPLETED
Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations
Lead Sponsor:
Seattle Children's Hospital
Collaborating Sponsors:
Orthocare Innovations
Hanger Clinic: Prosthetics & Orthotics
Conditions:
Cerebral Palsy (CP)
Eligibility:
All Genders
4-9 years
Phase:
NA
Brief Summary
Ambulatory children with cerebral palsy (CP) demonstrate altered lower limb biomechanical alignment in walking (e.g. excessive hip/knee flexion or equinus during stance) and experience walking activit...
Detailed Description
The goal of this proposal is to assess the feasibility of using a randomized waitlist study to acquire pilot data on a targeted clinical cohort of children with CP evaluating the effectiveness of AFO-...
Eligibility Criteria
Inclusion
- ambulatory children with spastic diplegia CP,
- spasticity primary movement disorder
- aged 4-9 years
- Gross Motor Function Classification System (GMFCS) levels of II or III
- clinically appropriate for a solid AFO based on physical exam/visual gait analysis criteria of:
- insufficient gastrocnemius length to allow knee extension with ankle dorsiflexion of 10 degrees and an uncompromised foot arch;
- low tone in the calf muscles with inability to control dorsiflexion during stance;
- insufficient calf muscle strength to prevent excessive dorsiflexion in stance and create a 'quasi stiff" ankle in terminal stance that allows the heel to rise from the ground; and
- insufficient triplanar boney stability of the foot during stance phase dorsiflexion
Exclusion
- Participants who have undergone:
- orthopedic or neurological surgery less than 6 months prior to enrollment or injection therapies (phenol, botulinum toxin) less than 3 months prior to enrollment will be excluded.
Key Trial Info
Start Date :
December 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03756571
Start Date
December 17 2018
End Date
September 1 2021
Last Update
October 14 2021
Active Locations (1)
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1
Seattle Children's Research Institute
Seattle, Washington, United States, 98101