Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations

Completed · Not applicable

Conditions studied: Cerebral Palsy (CP)

In brief

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.

Key facts

Study ID: NCT03756571
Run by: Seattle Children's Hospital
People needed: 21
Starts: 2018-12-17
Expected to finish: 2021-09-01
Last updated by the study team: 2021-10-14

Who can join

Age: 4 and older, up to 9. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Seattle Children's Research Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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