Investigating the Effects of Sensory Input Orthotics in Disorders of Posture and Movement

Study Overview
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Brief Summary
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The purpose of this research study is to use tools for measuring function and movement in pediatric populations to measure the impact of input orthotic interventions in children with cerebral palsy.

Detailed Description
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Sensory processing begets movement. In persons with disorders of posture and movement due to cerebral palsy, an impaired ability to integrate multiple senses including pressure from ground, limb proprioception, and vestibular inputs leads to a movement pattern that is coarse, spastic and inefficient. In the pediatric rehab clinic spastic movement disorders have been treated with flexible, molded orthotics for the foot and ankle (AFO) to enhance sensation of ground reaction forces, and flexible elastomeric compression garments to enhance body and limb proprioception. While the investigators observed substantial improvements in gait quality and postural stability using sensory input orthotics, these clinical observations have not been objectively quantified. The goal is to use validated tools for measuring function and movement in pediatric populations in order to gather data on the value of sensory input orthotic interventions in children with cerebral palsy. Under the term, sensory input orthotic, the following items are included which will be used in this study. 1) A flexible, thin polypropylene shell ankle-foot orthotic designed according to Hylton et al. Journal of P&O 1989. 2) Wearable elastomeric compression garments manufactured by SPIO or from the Boston Brace DMO garment line. 3) A vibrating anklet that provides subsensory vibrational stimulation to the leg, manufactured by Accelera.

Official Title
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Investigating the Effects of Sensory Input Orthotics in Disorders of Posture and Movement

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Device: Flexible orthotic
* Device: Standard orthotic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cerebral palsy Ages 6 months to 21 years No prior prescription of sensory input ankle-foot orthotics Clinical diagnosis of abnormal gait and mobility Exclusion Criteria: • Joint contracture that severely limits function such as ability to passively open the hand, extend the arm at the elbow or to stand with feet flat on the ground or knees in an extended position.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flexible orthotic<br>Sensory input flexible ankle foot orthotic (SIAFO) with appropriate lycra garments | Device: Flexible orthotic<br>* Participants will receive the SIAFO to wear<br>|
| Active Comparator: Standard of care<br>Standard of care solid ankle foot orthotic (AFO) | Device: Standard orthotic<br>* Participants will received the standard AFO to wear<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in perceived psychosocial well-being - parents | Participant's parents will complete the Pediatric Evaluation of Disabilities Inventory (PEDI) | Baseline to 2 months | 
| Change in perceived psychosocial well-being - children | Children ages 9 and up will be administered the Psychosocial Impact of Assistive Device Survey (PIADS) by a trained clinician | Baseline to 2 months | 
| Change in gross motor function | A trained physical therapist will administer the global gross motor function (GMFM-88) assessment | Baseline to 2 months | 
| Change in lower extremity kinematics and posture stability | Participants will perform a 10 second walk test in the Motor Control Lab while being recorded with a Vicon 3D motion capture system. | Baseline to 2 months | 
| Change in balance | Participants will perform the 14-point items of the Pediatric Balance Scale in the Motor Control Lab while being recorded with a Vicon 3D motion capture system. | Baseline to 2 months |