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

NCT04091594 | Withdrawn FDA Device

• 1 other identifier: HM20015260
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (5)

• Change in perceived psychosocial well-being - parents

  Participant's parents will complete the Pediatric Evaluation of Disabilities Inventory (PEDI)

  Baseline to 2 months

• 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

• Change in gross motor function

  A trained physical therapist will administer the global gross motor function (GMFM-88) assessment

  Baseline to 2 months

• 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

• 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

Study Arms (2)

Flexible orthotic

EXPERIMENTAL

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

Device: Flexible orthotic

Standard of care

ACTIVE COMPARATOR

Standard of care solid ankle foot orthotic (AFO)

Device: Standard orthotic

Interventions

Flexible orthotic DEVICE

Participants will receive the SIAFO to wear

Flexible orthotic

Standard orthotic DEVICE

Participants will received the standard AFO to wear

Standard of care

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Olivier Rolin

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 17, 2019
• Study Start: January 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: July 1, 2021
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)