Balance Control in Children With Cerebral Palsy

May 26, 2015 updated by: John Jeka, Temple University

Sensor Fusion for Balance Control in Children With Cerebral Palsy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19122
        • Recruiting
        • Temple University
        • Contact:
        • Principal Investigator:
          • John Jeka, PhD
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Shriners Hospital for Children
        • Principal Investigator:
          • John Jeka, PhD
        • Contact:
          • Anastasia Zarkou, PT, MS
          • Phone Number: 5141 215-430-4000
          • Email: azarkou@udel.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Children with Cerebral palsy
  1. Sensory integration testing
  2. SR stimulation and Sensory integration testing
Procedure: Sensory Integration Testing
Investigate how sensory information are integrated during upright stance when visual and body senses are challenged in a virtual reality environment
Other Names:
  • Sensor Fusion paradigm
Procedure: SR stimulation & Sensory integration testing
Use SR stimulation to improve sensory integration when visual and body senses are challenged in a virtual reality environment
Active Comparator: Children with Typical Development
  1. Sensory integration testing
  2. SR stimulation and Sensory integration testing
Procedure: Sensory Integration Testing
Investigate how sensory information are integrated during upright stance when visual and body senses are challenged in a virtual reality environment
Other Names:
  • Sensor Fusion paradigm
Procedure: SR stimulation & Sensory integration testing
Use SR stimulation to improve sensory integration when visual and body senses are challenged in a virtual reality environment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gain response
Time Frame: 1 day
For both the sensory reweighting testing, the visual signal will be displayed as a visual flow with translation in anterior-posterior (AP) direction (i.e., sagittal plane) and presented at different amplitudes (0.25 and 0.5 cm) at 0.2 Hz to measure: the change in gain (weighting) to vision (intramodal effect); and a change in gain to vibration and galvanic stimulation (intermodal effects). Gain for each modality relative to both the leg segment AP translation and trunk segment AP translation will be measured.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gain response
Time Frame: 1 day
For the sensory reweighting with the addition of SR stimulation testing, the visual signal will be displayed as a visual flow with translation in anterior-posterior (AP) direction (i.e., sagittal plane) and presented at different amplitudes (0.25 and 0.5 cm) at 0.2 Hz to measure: the change in gain (weighting) to vision (intramodal effect); and a change in gain to vibration and galvanic stimulation (intermodal effects). Gain for each modality relative to both the leg segment AP translation and trunk segment AP translation will be measured.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Collaborators

Shriners Hospitals for Children
University of Delaware

Investigators

  • Principal Investigator: John Jeka, PhD, Temple University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 26, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 28, 2015

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 71002-PHI-14
  • 22173 (Other Identifier: Temple IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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