Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations (CP-AFOFC)

• ClinicalTrials.gov Identifier: NCT03756571
• Recruitment Status: Completed
• First Posted: November 28, 2018
• Results First Posted: August 24, 2021
• Last Update Posted: October 14, 2021
• Sponsor: Seattle Children's Hospital
• Collaborators: Orthocare Innovations; Hanger Clinic: Prosthetics & Orthotics; Cascade DAFO
• Information provided by (Responsible Party): Kristie Bjornson, Seattle Children's Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cerebral Palsy (CP)	Other: Ankle Foot Orthoses-Footwear Combination; Other: Traditional Solid Ankle AFO (TSAFO)	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Study Design and Randomization. A randomized waitlist trial will be used to compare the AFO-FC to TSAFO in ambulatory children with CP.
• Masking: Single (Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Biomechanics and Walking in Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations
• Actual Study Start Date: December 17, 2018
• Actual Primary Completion Date: February 28, 2020
• Actual Study Completion Date: September 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.
Active Comparator: 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)...	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.

Outcome Measures

Primary Outcome Measures :

1. Change in Baseline Gait Profile Score (GPS) at 3 Months-individual Lower Extremity Joint Kinematics [ Time Frame: 3 months post wearing assigned orthotic intervention ]
   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.
2. Change in Right Baseline Gait Deviation Index (GDI) at 3 Months [ Time Frame: 3 months post wearing assigned orthotic intervention ]
   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. Change in Baseline Walking Speed in Meters/Second (m/s) at 3 Months. [ Time Frame: 3 months post wearing assigned orthotic intervention ]
   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.
4. Change in Baseline Community Walking Activity Level at 3 Months in Strides/Day. [ Time Frame: 3 months post wearing assigned orthotic intervention ]
   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.
5. Change in Baseline Community Walking Intensity at 3 Months in Percent Time in High Stride Rates of > 60 Strides/Minute. [ Time Frame: 3 months post wearing assigned orthotic intervention ]
   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.
6. Change in Left Baseline Gait Deviation Index (GDI) at 3 Months [ Time Frame: 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.

Secondary Outcome Measures :

1. Change in Balance From Baseline to 3 Months as Measured by Pediatric Balance Scale. [ Time Frame: 3 months post wearing assigned orthotic intervention ]
   The Pediatric Balance Scale (PBS) is a functional measure intended to assess balance in a clinical setting for children with neurological impairment. The PBS is a scaled scoring with range of 0 to 100 with a higher score a better outcome.
2. Change in Mobility From Baseline to 3 Months Change in Gait Outcome Assessment List (GOAL) Total Standard Score . [ Time Frame: 3 months post wearing assigned orthotic intervention ]
   Gait Outcomes Assessment List (GOAL) - The Gait Outcomes Assessment List (GOAL) is a outcome assessment to evaluate gait priorities and functional mobility for ambulant children with CP. The GOAL range of standard scores is 0 to 100 with a high score a better outcome. The GOAL will allow clinicians to better understand the motor abilities, priorities, and expectations of ambulant children with CP and to improve decision-making about appropriate interventions. The GOAL consists of 48 items grouped into seven domains: 1) activities of daily living and independence; 2) gait function and mobility; 3) pain, discomfort and fatigue; 4) physical activities, sports and recreation; 5) gait pattern and appearance; 6) use of braces and mobility aids; and 7) body image and self-esteem.
3. Difference Between Groups in Physical Function T-scores of Patient-Reported Outcomes Measurement Information System (PROMIS) After 3 Months Wearing Devices/Shoes. [ Time Frame: 3 months post wearing assigned orthotic intervention ]
   Parental report of Physical Function Mobility subscale T-scores from the Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric survey. The PROMIS Physical Function subscale T score range is 0 to 100 with a higher score a better outcome. The mean of the T-score for Physical Function Mobility is 50 with a SD of 10, For parental report a score > or equal to 45 is consider Good, 36 - 44 Fair and < or equal to 35 Poor physical Function
4. Difference Between Groups in Pain/Fatigue Level of the Gait Outcomes Assessment List (GOAL) After Wearing Devices/Shoes for 3 Months [ Time Frame: 3 months post wearing assigned orthotic intervention ]
   Parental report of pain/fatigue domain standard scores on the Gait Outcomes Assessment List (GOAL). The range of the pain/fatigue subscale of the GOAL 0 to 100. A higher score is a better outcome.
5. Difference Between Groups in Pain Interference After Wearing Devices/Shoes for 3 Months Pain Interference T Scores From PROMIS Pediatric Survey [ Time Frame: 3 months post wearing assigned orthotic intervention ]
   Parental report of selected pain and pain interference items from the Patient-Reported Outcomes Measurement Information System (PROMIS)pediatric survey. The Pediatric PROMIS pain interference subscale T score range is 0 to 100 with a lower score a better outcome. The mean is 50 with SD of 10. For the Pain interference a T score < 50 is considered within normal limits.
6. Difference Between Groups in Satisfaction With Orthoses/Shoes After Wearing for 3 Months Per Orthotic and Prosthetic Users Survey (OPUS). [ Time Frame: 3 months post wearing assigned orthotic intervention ]
   Parental report of satisfaction raw score items from the Orthotic and Prosthetic Users' Survey (OPUS). The range of OPUS scores is 11-55 with a higher score a better outcome. The raw scores are employed as the survey validation for Rasch scores is not completed for children.

Eligibility Criteria

• Ages Eligible for Study: 4 Years to 9 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Washington

Seattle Children's Research Institute

Seattle, Washington, United States, 98101

Sponsors and Collaborators

Seattle Children's Hospital

Orthocare Innovations

Hanger Clinic: Prosthetics & Orthotics

Cascade DAFO

Investigators

• Principal Investigator: Kristie F Bjornson, PhD, PT; Seattle Children's Research Institute

  Study Documents (Full-Text)

Documents provided by Kristie Bjornson, Seattle Children's Hospital:

Study Protocol  [PDF] August 7, 2018

Statistical Analysis Plan  [PDF] August 7, 2018

More Information

• Responsible Party: Kristie Bjornson, Associate Professor, Pediatrics, Seattle Children's Hospital
• ClinicalTrials.gov Identifier: NCT03756571
• Other Study ID Numbers: R21HD094823 ( U.S. NIH Grant/Contract )
• First Posted: November 28, 2018
• Results First Posted: August 24, 2021
• Last Update Posted: October 14, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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