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

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ClinicalTrials.gov Identifier: NCT04091594
Recruitment Status : Not yet recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Device: Flexible orthotic Device: Standard orthotic Not Applicable

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 orthoic, 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
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 : October 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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.

  5. 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.



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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of cerebral palsy
  • Ages 6 months to 21 years
  • No prior prescription of sensory input orthotics

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.


Information from the National Library of Medicine

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


Contacts
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Contact: Olivier Rolin 804-310-2644 Olivier.rolin@vcuhealth.org
Contact: James Thomas 804-828-0234 jthomas32@vcu.edu

Locations
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United States, Virginia
Virginia Commonwealth University Not yet recruiting
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Olivier Rolin Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT04091594     History of Changes
Other Study ID Numbers: HM20015260
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases