Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:4 - 9
Updated:4/6/2019
Start Date:December 17, 2018
End Date:July 31, 2020
Contact:Kristie F Bjornson, PhD, PT
Email:kristie.bjornson@seattlechildrens.org
Phone:206-884-2066

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Biomechanics and Walking in Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations

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.

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-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 spastic diplegia CP, ages 4-9 years, with bilateral crouch or equinus gait
pattern, comparing gait in TSAFO to the AFO-FCs.

Aim 1: Examine the effect of AFO-FC on individual joint kinematics, overall gait deviations
and walking speed as compared to the TSAFO in children with CP. Multiple gait deviations
(e.g. crouch or equinus) in CP result in slow, inefficient walking [14]. We hypothesize that
the individualized ankle angle, leg segment alignment, and footwear profiles of the AFO-FCs
will optimize lower limb joint kinematics, decrease overall gait deviations facilitating
longer step lengths (improved stance stability), with resultant increased gait speed as
compared to TSAFO. Instrumented gait analysis will assess gait speed and calculate changes in
joint specific kinematics with the Gait Variable Score (GVS) and overall combined gait
kinematics with the GDI.

Aim 2: Examine the effect of AFO-FC on daily walking activity, balance, mobility, and
satisfaction as compared to the TSAFO in children with CP. We hypothesize that the AFO-FC
will positively affect community walking activity levels, balance, physical activity and
satisfaction as compared to the TSAFO. Walking activity will be captured by the StepWatch
accelerometer; balance by the Pediatric Balance Scale; physical activity by the PROMIS®
Pediatric Physical Activity and the Activities Scale for Kids (ASKp); and satisfaction with
device by the Orthotic and Prosthetic Users' Survey (OPUS).

Inclusion Criteria:

- 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:

1. insufficient gastrocnemius length to allow knee extension with ankle dorsiflexion
of 10 degrees and an uncompromised foot arch;

2. low tone in the calf muscles with inability to control dorsiflexion during
stance;

3. 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

4. insufficient triplanar boney stability of the foot during stance phase
dorsiflexion

Exclusion Criteria:

- 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.
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