Investigating the Effects of Sensory Input Orthotics in Disorders of Posture and Movement
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|ClinicalTrials.gov Identifier: NCT04091594|
Recruitment Status : Suspended (PI seeking alternative funding for the study)
First Posted : September 17, 2019
Last Update Posted : September 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Device: Flexible orthotic Device: Standard orthotic||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Investigating the Effects of Sensory Input Orthotics in Disorders of Posture and Movement|
|Estimated Study Start Date :||January 2021|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||July 2021|
Experimental: Flexible orthotic
Sensory input flexible ankle foot orthotic (SIAFO) with appropriate lycra garments
Device: Flexible orthotic
Participants will receive the SIAFO to wear
Active Comparator: Standard of care
Standard of care solid ankle foot orthotic (AFO)
Device: Standard orthotic
Participants will received the standard AFO to wear
- Change in perceived psychosocial well-being - parents [ Time Frame: Baseline to 2 months ]Participant's parents will complete the Pediatric Evaluation of Disabilities Inventory (PEDI)
- Change in perceived psychosocial well-being - children [ Time Frame: Baseline to 2 months ]Children ages 9 and up will be administered the Psychosocial Impact of Assistive Device Survey (PIADS) by a trained clinician
- Change in gross motor function [ Time Frame: Baseline to 2 months ]A trained physical therapist will administer the global gross motor function (GMFM-88) assessment
- Change in lower extremity kinematics and posture stability [ Time Frame: Baseline to 2 months ]Participants will perform a 10 second walk test in the Motor Control Lab while being recorded with a Vicon 3D motion capture system.
- Change in balance [ Time Frame: Baseline to 2 months ]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.
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): NCT04091594
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Olivier Rolin||Virginia Commonwealth University|