Clinical trial NCT03756571: Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations
Official title: Biomechanics and Walking in Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy (CP)
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Orthocare Innovations
name: Hanger Clinic: Prosthetics & Orthotics
name: Cascade Dafo
First posted: 2018-11-28
Enrollment: 21
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change in Baseline Gait Profile Score (GPS) at 3 Months-individual Lower Extremity Joint Kinematics
timeFrame: 3 months post wearing assigned orthotic intervention
measure: Change in Right Baseline Gait Deviation Index (GDI) at 3 Months
timeFrame: 3 months post wearing assigned orthotic intervention
measure: Change in Baseline Walking Speed in Meters/Second (m/s) at 3 Months.
timeFrame: 3 months post wearing assigned orthotic intervention
measure: Change in Baseline Community Walking Activity Level at 3 Months in Strides/Day.
timeFrame: 3 months post wearing assigned orthotic intervention
measure: Change in Baseline Community Walking Intensity at 3 Months in Percent Time in High Stride Rates of > 60 Strides/Minute.
timeFrame: 3 months post wearing assigned orthotic intervention
measure: Change in Left Baseline Gait Deviation Index (GDI) at 3 Months
timeFrame: Change in Right baseline Gait Deviation Index (GDI) at 3 months
Secondary outcomes:
measure: Change in Balance From Baseline to 3 Months as Measured by Pediatric Balance Scale.
timeFrame: 3 months post wearing assigned orthotic intervention
measure: Change in Mobility From Baseline to 3 Months Change in Gait Outcome Assessment List (GOAL) Total Standard Score .
timeFrame: 3 months post wearing assigned orthotic intervention
measure: Difference Between Groups in Physical Function T-scores of Patient-Reported Outcomes Measurement Information System (PROMIS) After 3 Months Wearing Devices/Shoes.
timeFrame: 3 months post wearing assigned orthotic intervention
measure: Difference Between Groups in Pain/Fatigue Level of the Gait Outcomes Assessment List (GOAL) After Wearing Devices/Shoes for 3 Months
timeFrame: 3 months post wearing assigned orthotic intervention
measure: Difference Between Groups in Pain Interference After Wearing Devices/Shoes for 3 Months Pain Interference T Scores From PROMIS Pediatric Survey
timeFrame: 3 months post wearing assigned orthotic intervention
measure: Difference Between Groups in Satisfaction With Orthoses/Shoes After Wearing for 3 Months Per Orthotic and Prosthetic Users Survey (OPUS).
timeFrame: 3 months post wearing assigned orthotic intervention
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Research Institute
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Kristie F Bjornson, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: