Recruiting

Balance Control

Sponsor:

Temple University

Code:

NCT02456376

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Accepted

Interventions

Sensory Integration Testing

SR stimulation & Sensory integration testing

Study Details

Brief summary:

The purpose of this study is to investigate how sensory information processing affects balance ability in children with cerebral palsy (CP). An additional goal is to determine if a subsensory electrical stimulation called Stochastic Resonance (SR) Stimulation, can improve balance in children with CP. Children with CP and children with typical development will participate and complete a series of clinical and balance assessments. They will also be tested in a sensor fusion paradigm to investigate potential deficits in the dynamic integration of visual, vestibular and proprioceptive information during upright stance. SR stimulation will then be used to potentially improve these deficits and subsequently their balance ability.

Conditions

Cerebral Palsy

Study ID

NCT02456376

Start date

May, 2014

Status verified date

May, 2015

Completion date

Dec, 2016

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Diagnosis of spastic diplegia CP (GMFCS I- III)\*
  • Ability to stand independently for approximately 2 min

Exclusion Criteria:

  • Lower extremity surgery or fractures in the year prior testing
  • Joint instability or dislocation in the lower extremities
  • Botulinum toxin injections in the lower extremities within the past 6 months\*
  • Marked visual or hearing deficits
  • Uncontrolled seizure disorder
  • Implanted medical device that may be contraindicated with application of SR stimulation

  • Asterisk indicates the eligibility criteria that should be met only by children with CP

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Children with Cerebral palsy

1. Sensory integration testing
2. SR stimulation and Sensory integration testing

active comparator: Children with Typical Development

1. Sensory integration testing
2. SR stimulation and Sensory integration testing

Interventions

Sensory Integration Testing

Investigate how sensory information are integrated during upright stance when visual and body senses are challenged in a virtual reality environment

SR stimulation & Sensory integration testing

Use SR stimulation to improve sensory integration when visual and body senses are challenged in a virtual reality environment

Primary outcome measure

  • Gain response [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Anastasia Zarkou, PT, MS

azarkou@udel.edu

Samuel CK Lee, PT, PhD

slee@udel.edu

Locations

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19122

Contacts

Sung-Jae Hwang, PhD

hwangsungjae@gmail.com

Principal Investigator:

John Jeka, PhD

Shriners Hospital for Children

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Anastasia Zarkou, PT, MS

215-430-4000azarkou@udel.edu

Principal Investigator:

John Jeka, PhD

More Information

Sponsor

Temple University

Last update posted

May 28, 2015

Last verified

May, 2015

Keywords

  • Sensor Fusion
  • Stochastic Resonance Stimulation
  • Sensory deficits
  • Postural Control

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Temple University on 2015-05-28.