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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04091594
• Other study ID #: HM20015260
• Status: Withdrawn
• Phase: N/A
• Start date: January 2021
• Est. completion date: July 2021

Study information

• Verified date: December 2020
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• Flexible orthotic
Participants will receive the SIAFO to wear
• Standard orthotic
Participants will received the standard AFO to wear

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in perceived psychosocial well-being - parents	Participant's parents will complete the Pediatric Evaluation of Disabilities Inventory (PEDI)	Baseline to 2 months
Primary	Change in perceived psychosocial well-being - children	Children ages 9 and up will be administered the Psychosocial Impact of Assistive Device Survey (PIADS) by a trained clinician	Baseline to 2 months
Primary	Change in gross motor function	A trained physical therapist will administer the global gross motor function (GMFM-88) assessment	Baseline to 2 months
Primary	Change in lower extremity kinematics and posture stability	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
Primary	Change in balance	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