Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-08 @ 11:00 PM
Study NCT ID:
NCT04091594
Status:
WITHDRAWN
Last Update Posted:
2020-12-08
First Post:
2019-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Effects of Sensory Input Orthotics in Disorders of Posture and Movement
Sponsor:
Virginia Commonwealth University
Organization:
Study Overview
Official Title:
Investigating the Effects of Sensory Input Orthotics in Disorders of Posture and Movement
Status:
WITHDRAWN
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient funding was available and the study could not be started.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: