NCT04091594

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
DEVICE	Flexible orthotic	Participants will receive the SIAFO to wear
DEVICE	Standard orthotic	Participants will received the standard AFO to wear

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-05-01
• Completion: 2021-07-01
• First posted: 2019-09-17
• Last updated: 2020-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study