Clinical trial NCT04091594: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in perceived psychosocial well-being - parents
timeFrame: Baseline to 2 months
measure: Change in perceived psychosocial well-being - children
timeFrame: Baseline to 2 months
measure: Change in gross motor function
timeFrame: Baseline to 2 months
measure: Change in lower extremity kinematics and posture stability
timeFrame: Baseline to 2 months
measure: Change in balance
timeFrame: Baseline to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Olivier Rolin
role: PRINCIPAL_INVESTIGATOR
References: