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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Flexible orthotic; Device: Standard orthotic

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Olivier Rolin, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: September 13, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 4, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: HM20015260

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes