Skip to main content
Clinical Trials/NCT04091594
NCT04091594
Withdrawn
Not Applicable

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

Virginia Commonwealth University1 site in 1 countryJanuary 2021
ConditionsCerebral Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Virginia Commonwealth University
Locations
1
Primary Endpoint
Change in lower extremity kinematics and posture stability
Status
Withdrawn
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2021
End Date
July 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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.

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

Study Sites (1)

Loading locations...

Similar Trials