Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations

NCT ID: NCT03756571

Last Updated: 2021-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-17
• Study Completion Date: 2021-09-01

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 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.

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-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 Profile Score (GPS) 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 Patient Reported Outcomes Measurement System (PROMIS®) Pediatric Physical Activity and the Gait Outcomes Assessment List (GOAL); and satisfaction with device by the Orthotic and Prosthetic Users' Survey (OPUS).

Conditions

Cerebral Palsy (CP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ankle Foot Orthoses-Footwear Combination

The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.

Group Type: EXPERIMENTAL

Ankle Foot Orthoses-Footwear Combination

Intervention Type: OTHER

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.

Traditional Solid Ankle AFO (TSAFO)

The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the "traditional" SAFO (TSAFO)...

Group Type: ACTIVE_COMPARATOR

Traditional Solid Ankle AFO (TSAFO)

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orthocare Innovations

INDUSTRY

Sponsor Role: collaborator

Hanger Clinic: Prosthetics & Orthotics

OTHER

Sponsor Role: collaborator

Cascade Dafo

INDUSTRY

Sponsor Role: collaborator

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kristie Bjornson

Associate Professor, Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristie F Bjornson, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

Seattle Children's Research Institute

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R21HD094823

Identifier Type: NIH

Identifier Source: org_study_id

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