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

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ClinicalTrials.gov Identifier: NCT03756571
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Collaborators:
Orthocare Innovations
Hanger Clinics
Cascade DAFO
Information provided by (Responsible Party):
Kristie Bjornson, Seattle Children's Hospital

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 Variable Score (GVS) 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 PROMIS® Pediatric Physical Activity and the Activities Scale for Kids (ASKp); and satisfaction with device by the Orthotic and Prosthetic Users' Survey (OPUS).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover 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 GVS, 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
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in baseline Gait Variable Score at 3 months-individual lower extremity joint kinematics [ Time Frame: 3 months post wearing assigned orthotic intervention ]
    Calculate the Gait Variable Score (GVS) from the GDI. Similar to the GDI, 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 GDI. The GPS is calculated on all gait features via the root mean square difference between the subject's data and the average of the normative data set [13]. GVS, also a single number, can only be derived from the GPS and consists of nine joint/limb gait variables for each side of the body (i.e. sagittal knee flexion midstance with an overall score for the pelvis [52].

  2. Change in 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 100 scale) captures cumulative changes occurring at multiple joints and segments. GDI has been shown to have concurrent validity with gross motor function and functional walking levels in children with CP. The GDI is responsive to the effect of surgical lengthening of the gastrosoleus [44] and AFO use compared to barefoot.

  3. Change in baseline walking speed at 3 months. [ Time Frame: 3 months post wearing assigned orthotic intervention ]
    Gait speed will be captured during the three dimensional gait analysis testing.

  4. Change in baseline community walking activity level at 3 months [ Time Frame: 3 months post wearing assigned orthotic intervention ]
    Community walking activity will be captured by the ankle worn StepWatch Accelerometer capturing average stride/day.

  5. Change in baseline community walking intensity at 3 months. [ Time Frame: 3 months post wearing assigned orthotic intervention ]
    Community walking activity will be captured by the ankle worn StepWatch Accelerometer capturing strides at moderate/high stride rates.


Secondary Outcome Measures :
  1. Change in baseline balance at 3 months. [ 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 persons with neurological impairment. Test-retest reliability has been established with pediatric norms allowing discrimination between functional levels of children with CP. MCID has been published for children with CP

  2. Change in baseline mobility at 3 months. [ Time Frame: 3 months post wearing assigned orthotic intervention ]
    Gait Outcomes Assessment List (GOAL) - The Gait Outcomes Assessment List (GOAL) is a new outcome assessment to evaluate gait priorities and functional mobility for ambulant children with CP 46. 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. Change in baseline activity at 3 months [ Time Frame: 3 months post wearing assigned orthotic intervention ]
    Parental report of selected activity items from the Patient-Reported Outcomes Measurement Information System (PROMIS)pediatric survey.

  4. Change in baseline fatigue at 3 months [ Time Frame: 3 months post wearing assigned orthotic intervention ]
    Parental report of selected fatigue items from the Patient-Reported Outcomes Measurement Information System (PROMIS)pediatric survey.

  5. Change in baseline pain at 3 months [ 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.

  6. Change in baseline satisfaction with orthoses at 3 months [ Time Frame: 3 months post wearing assigned orthotic intervention ]
    Parental report of satisfaction items from the Orthotic and Prosthetic Users' Survey (OPUS).



Information from the National Library of Medicine

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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03756571


Contacts
Contact: Kristie F Bjornson, PhD, PT 206-884-2066 kristie.bjornson@seattlechildrens.org
Contact: Sinear Sadang, BS 206-884-1152 sinear.sadang@seattlechildrens.org

Locations
United States, Washington
Seattle Children's Research Institute Recruiting
Seattle, Washington, United States, 98101
Contact: Kristie Bjornson, PT, PhD    206-884-2066    kristie.bjornson@seattlechildrens.org   
Contact: Sinear Sadang, BS    206-884-1152    sinear.sadang@seattlechildrens.org   
Sponsors and Collaborators
Seattle Children's Hospital
Orthocare Innovations
Hanger Clinics
Cascade DAFO
Investigators
Principal Investigator: Kristie F Bjornson, PhD, PT Seattle Children's Research Institute

Responsible Party: Kristie Bjornson, Associate Professor, Pediatrics, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT03756571     History of Changes
Other Study ID Numbers: R21HD094823 ( U.S. NIH Grant/Contract )
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
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
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases