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

NCT ID: NCT04091594

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2021-07-31

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Flexible orthotic

Sensory input flexible ankle foot orthotic (SIAFO) with appropriate lycra garments

Group Type EXPERIMENTAL

Flexible orthotic

Intervention Type DEVICE

Participants will receive the SIAFO to wear

Standard of care

Standard of care solid ankle foot orthotic (AFO)

Group Type ACTIVE_COMPARATOR

Standard orthotic

Intervention Type DEVICE

Participants will received the standard AFO to wear

Interventions

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Flexible orthotic

Participants will receive the SIAFO to wear

Intervention Type DEVICE

Standard orthotic

Participants will received the standard AFO to wear

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Rolin

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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HM20015260

Identifier Type: -

Identifier Source: org_study_id