N/A
N=21
Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations
Cerebral Palsy (CP)
Bottom Line
View on ClinicalTrials.gov: NCT03756571 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Change in Baseline Gait Profile Score (GPS) at 3 Months-individual Lower Extremity Joint Kinematics — 0.41; -0.48 units on a scale — p=0.36
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ankle Foot Orthoses-Footwear Combination (Other); Traditional Solid Ankle AFO (TSAFO) (Other)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Seattle Children's Hospital
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Baseline Gait Profile Score (GPS) at 3 Months-individual Lower Extremity Joint Kinematics |
0.41; -0.48 | 0.36 |
| PRIMARY Change in Right Baseline Gait Deviation Index (GDI) at 3 Months |
.07; 3.2 | 0.50 |
| PRIMARY Change in Baseline Walking Speed in Meters/Second (m/s) at 3 Months. |
-.03; .13 | 0.15 |
| PRIMARY Change in Baseline Community Walking Activity Level at 3 Months in Strides/Day. |
-804; -182 | 0.23 |
| PRIMARY Change in Baseline Community Walking Intensity at 3 Months in Percent Time in High Stride Rates of > 60 Strides/Minute. |
-.03; -.15 | 0.70 |
| PRIMARY Change in Left Baseline Gait Deviation Index (GDI) at 3 Months |
-1.5; 1.3 | 0.33 |
| SECONDARY Change in Balance From Baseline to 3 Months as Measured by Pediatric Balance Scale. |
12.8; 3.5 | 0.03 sig |
| SECONDARY Change in Mobility From Baseline to 3 Months Change in Gait Outcome Assessment List (GOAL) Total Standard Score . |
7.91; -0.44 | 0.03 sig |
| SECONDARY Difference Between Groups in Physical Function T-scores of Patient-Reported Outcomes Measurement Information System (PROMIS) After 3 Months Wearing Devices/Shoes. |
36.2; 32.9 | 0.08 |
| SECONDARY Difference Between Groups in Pain/Fatigue Level of the Gait Outcomes Assessment List (GOAL) After Wearing Devices/Shoes for 3 Months |
88.3; 78.2 | 0.18 |
| SECONDARY Difference Between Groups in Pain Interference After Wearing Devices/Shoes for 3 Months Pain Interference T Scores From PROMIS Pediatric Survey |
45.6; 53.4 | 0.15 |
| SECONDARY Difference Between Groups in Satisfaction With Orthoses/Shoes After Wearing for 3 Months Per Orthotic and Prosthetic Users Survey (OPUS). |
42.1; 42.8 | 0.80 |
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.
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:
- 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
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.
Data sourced from ClinicalTrials.gov (NCT03756571). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.