- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04091594
Investigating the Effects of Sensory Input Orthotics in Disorders of Posture and Movement
Study Overview
Status
Conditions
Intervention / Treatment
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
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Flexible orthotic
Sensory input flexible ankle foot orthotic (SIAFO) with appropriate lycra garments
|
Participants will receive the SIAFO to wear
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Active Comparator: Standard of care
Standard of care solid ankle foot orthotic (AFO)
|
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
Time Frame: Baseline to 2 months
|
Participant's parents will complete the Pediatric Evaluation of Disabilities Inventory (PEDI)
|
Baseline to 2 months
|
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
|
Baseline to 2 months
|
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
|
Baseline to 2 months
|
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.
|
Baseline to 2 months
|
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.
|
Baseline to 2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olivier Rolin, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20015260
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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