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

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status

Withdrawn

Conditions

Cerebral Palsy

Treatments

Device: Standard orthotic
Device: Flexible orthotic

Study type

Interventional

Funder types

Other

Identifiers

NCT04091594
HM20015260

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

6 months to 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Flexible orthotic
Experimental group
Description:
Sensory input flexible ankle foot orthotic (SIAFO) with appropriate lycra garments
Treatment:
Device: Flexible orthotic
Standard of care
Active Comparator group
Description:
Standard of care solid ankle foot orthotic (AFO)
Treatment:
Device: Standard orthotic

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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