Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations

NCT03756571 | Completed Results

• 1 other identifier: R21HD094823
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy (CP)

Outcome Measures

Primary Outcomes (6)

• Change in Baseline Gait Profile Score (GPS) at 3 Months-individual Lower Extremity Joint Kinematics

  The Gait Profile Score (GPS) represents the pattern of deviation as a single number and is derived from the same individual joint/limb gait kinematics as Gait Deviation Index (GDI) The GPS minimum value is 0 and maximum value is 20. A higher score is a worse outcome. An minimally clinically important difference is published to be 1.6 for children with CP.

  3 months post wearing assigned orthotic intervention

• Change in Right Baseline Gait Deviation Index (GDI) at 3 Months

  Gait Deviation Index (GDI) as a value representing overall gait deviation from a normal kinematic profile (0 to 120 scale) captures cumulative changes occurring at multiple joints and segments by side left/right. GDI has been shown to have concurrent validity with gross motor function and functional walking levels in children with CP. A score \> 100 is considered in the normal range. A higher score is a better outcome.

  3 months post wearing assigned orthotic intervention

• Change in Baseline Walking Speed in Meters/Second (m/s) at 3 Months.

  Gait speed will be captured during the three dimensional gait analysis testing. Gait speed is measured in meters per second (m/sec) with range from 0 to \~ 3.0 m/sec for walking in children. A higher number of m/sec is considered a better outcome with minimally clinically important difference (MCID) of .10 m/s for persons with CP.

  3 months post wearing assigned orthotic intervention

• Change in Baseline Community Walking Activity Level at 3 Months in Strides/Day.

  Community walking activity will be captured by the ankle worn StepWatch ® accelerometer capturing change in average strides/day. The StepWatch ® is a two dimension accelerometer validated to capture when the foot leaves the ground for a metric of stride counts within the context of daily life. Average strides/day can range from 0 to unlimited strides/day. A higher number of strides/day is considered a better outcome.

  3 months post wearing assigned orthotic intervention

• Change in Baseline Community Walking Intensity at 3 Months in Percent Time in High Stride Rates of > 60 Strides/Minute.

  Community walking activity will be captured by the ankle worn StepWatch Accelerometer capturing % time at high stride rates. Percent time at high stride rates (\> 60 strides/min) can range from 0 to 100% with a higher percent considered a better outcome.

  3 months post wearing assigned orthotic intervention

• Change in Left Baseline Gait Deviation Index (GDI) at 3 Months

  Gait Deviation Index (GDI) as a value representing overall gait deviation from a normal kinematic profile (0 to 120 scale) captures cumulative changes occurring at multiple joints and segments by side LEFT/RIGHT. GDI has been shown to have concurrent validity with gross motor function and functional walking levels in children with CP. A score \> 100 is considered in the 'normal' range. A higher score is a better outcome.

  Change in Right baseline Gait Deviation Index (GDI) at 3 months

Secondary Outcomes (6)

• Change in Balance From Baseline to 3 Months as Measured by Pediatric Balance Scale.

  3 months post wearing assigned orthotic intervention

• Change in Mobility From Baseline to 3 Months Change in Gait Outcome Assessment List (GOAL) Total Standard Score .

  3 months post wearing assigned orthotic intervention

• Difference Between Groups in Physical Function T-scores of Patient-Reported Outcomes Measurement Information System (PROMIS) After 3 Months Wearing Devices/Shoes.

  3 months post wearing assigned orthotic intervention

• Difference Between Groups in Pain/Fatigue Level of the Gait Outcomes Assessment List (GOAL) After Wearing Devices/Shoes for 3 Months

  3 months post wearing assigned orthotic intervention

• Difference Between Groups in Pain Interference After Wearing Devices/Shoes for 3 Months Pain Interference T Scores From PROMIS Pediatric Survey

  3 months post wearing assigned orthotic intervention

Study Arms (2)

Ankle Foot Orthoses-Footwear Combination

EXPERIMENTAL

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.

Other: Ankle Foot Orthoses-Footwear Combination

Traditional Solid Ankle AFO (TSAFO)

ACTIVE COMPARATOR

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)...

Other: Traditional Solid Ankle AFO (TSAFO)

Interventions

Ankle Foot Orthoses-Footwear Combination 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.

Ankle Foot Orthoses-Footwear Combination

Traditional Solid Ankle AFO (TSAFO) OTHER

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

Traditional Solid Ankle AFO (TSAFO)

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Orthocare Innovations: collaborator
• Hanger Clinic: Prosthetics & Orthotics: collaborator
• Cascade Dafo: collaborator

Study Sites (1)

Seattle Children's Research Institute

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

Due to hardware failure in Dec 2020, there was a data loss of the gait outcomes at the OrthoCare Biomechanics Lab (gait lab). Thus the gait lab variables of GPS and GDI have a sample size of 13, where all other outcomes have a sample size of 19.

Results Point of Contact

• Title: Kristie Bjornson, PT, PhD
• Organization: Seattle Children's Research Institute

Kristie.bjornson@seattlechildrens.org

206-884-2066

Study Officials

• Kristie F Bjornson, PhD, PT

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Primary outcomes are Gait Profile Score (GPS), Gait Deviation Index (GDI), gait speed from three dimensional gait analysis and community walking activity are all collected via technology (three dimensional gait lab, accelerometry, thus masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pediatrics

Model Details: Study Design and Randomization. A randomized waitlist trial will be used to compare the AFO-FC to TSAFO in ambulatory children with CP.

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 28, 2018
• Study Start: December 17, 2018
• Primary Completion: February 28, 2020
• Study Completion: September 1, 2021
• Last Updated: October 14, 2021
• Results First Posted: August 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)