Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations

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 activity limitations that negatively influence their ability to participate in day to day life. Ankle Foot Orthoses (AFO) are a fundamental rehabilitation strategy to facilitate walking in children with CP; yet, a review suggests that efficacy of the "traditional" solid AFO (TSAFO) in this population remains equivocal. A novel decision tree to guide orthotic prescription proposes a patient-specific method for adjusting AFO alignment and integrating footwear modifications (Ankle Foot Orthoses-Footwear Combinations, AFO-FC). This approach is based on visualizing the sagittal plane orientation of the ground reaction force vector with respect to lower limb segments during gait. The AFO-FC represents a paradigm shift in orthotic management as it accommodates ankle equinus contractures in a rigid AFO, reorients the tibial segment with a heel wedge under the AFO, and applies different heel, midsole and forefoot shoe modifications to restore lost ankle-foot rockers. The primary goal of AFO-FCs are to improve stability by facilitating more normal segment kinematics in single limb stance, decreasing hip/knee flexion. Despite their promise, evidence of an immediate positive effect on midstance alignment is limited, with no evidence of clinical effectiveness.

This proposal assesses 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-FCs as compared to TSAFO during daily life. Individual joint and combined kinematics and kinetics will be examined for potential mechanisms of action as well as daily walking performance, balance and satisfaction with the AFO-FC in 30 ambulatory children with CP, ages 4-9 years, with bilateral crouch or equinus gait pattern, comparing gait in TSAFO to the AFO-FCs.

Conditions

• Cerebral Palsy (CP)

Interventions

OTHER

Ankle Foot Orthoses-Footwear Combination

This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.

OTHER

Traditional Solid Ankle AFO (TSAFO)

This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.

Sponsors & Collaborators

• Orthocare Innovations

  collaborator INDUSTRY

• Hanger Clinic: Prosthetics & Orthotics

  collaborator OTHER

• Cascade Dafo

  collaborator INDUSTRY

• Seattle Children's Hospital

  lead OTHER

Principal Investigators

• Kristie F Bjornson, PhD, PT · Seattle Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

9 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-17

Primary Completion

2020-02-28

Completion

2021-09-01

Countries

• United States

Study Locations