Investigating the Effects of Sensory Input Orthotics in Disorders of Posture and Movement
Primary Purpose
Cerebral Palsy
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flexible orthotic
Standard orthotic
Sponsored by
About this trial
This is an interventional supportive care trial for Cerebral Palsy
Eligibility Criteria
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.
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Flexible orthotic
Standard of care
Arm Description
Sensory input flexible ankle foot orthotic (SIAFO) with appropriate lycra garments
Standard of care solid ankle foot orthotic (AFO)
Outcomes
Primary Outcome Measures
Change in perceived psychosocial well-being - parents
Participant's parents will complete the Pediatric Evaluation of Disabilities Inventory (PEDI)
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
Change in gross motor function
A trained physical therapist will administer the global gross motor function (GMFM-88) assessment
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04091594
First Posted
September 13, 2019
Last Updated
December 4, 2020
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT04091594
Brief Title
Investigating the Effects of Sensory Input Orthotics in Disorders of Posture and Movement
Official Title
Investigating the Effects of Sensory Input Orthotics in Disorders of Posture and Movement
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient funding was available and the study could not be started.
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flexible orthotic
Arm Type
Experimental
Arm Description
Sensory input flexible ankle foot orthotic (SIAFO) with appropriate lycra garments
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Standard of care solid ankle foot orthotic (AFO)
Intervention Type
Device
Intervention Name(s)
Flexible orthotic
Intervention Description
Participants will receive the SIAFO to wear
Intervention Type
Device
Intervention Name(s)
Standard orthotic
Intervention Description
Participants will received the standard AFO to wear
Primary Outcome Measure Information:
Title
Change in perceived psychosocial well-being - parents
Description
Participant's parents will complete the Pediatric Evaluation of Disabilities Inventory (PEDI)
Time Frame
Baseline to 2 months
Title
Change in perceived psychosocial well-being - children
Description
Children ages 9 and up will be administered the Psychosocial Impact of Assistive Device Survey (PIADS) by a trained clinician
Time Frame
Baseline to 2 months
Title
Change in gross motor function
Description
A trained physical therapist will administer the global gross motor function (GMFM-88) assessment
Time Frame
Baseline to 2 months
Title
Change in lower extremity kinematics and posture stability
Description
Participants will perform a 10 second walk test in the Motor Control Lab while being recorded with a Vicon 3D motion capture system.
Time Frame
Baseline to 2 months
Title
Change in balance
Description
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.
Time Frame
Baseline to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Rolin
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigating the Effects of Sensory Input Orthotics in Disorders of Posture and Movement
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