Balance Control in Children With Cerebral Palsy

NCT ID: NCT02456376

Last Updated: 2015-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Children with Cerebral palsy

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

Group Type EXPERIMENTAL

Sensory Integration Testing

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Children with Typical Development

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

Group Type ACTIVE_COMPARATOR

Sensory Integration Testing

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Interventions

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Sensory Integration Testing

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

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

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Sensor Fusion paradigm

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shriners Hospitals for Children

OTHER

Sponsor Role collaborator

University of Delaware

OTHER

Sponsor Role collaborator

Temple University

OTHER

Sponsor Role lead

Responsible Party

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John Jeka

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Jeka, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

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Temple University

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Shriners Hospital for Children

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anastasia Zarkou, PT, MS

Role: CONTACT

Samuel CK Lee, PT, PhD

Role: CONTACT

Facility Contacts

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Sung-Jae Hwang, PhD

Role: primary

Anastasia Zarkou, PT, MS

Role: primary

215-430-4000 ext. 5141

References

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Zarkou A, Lee SCK, Prosser LA, Hwang S, Jeka J. Stochastic resonance stimulation improves balance in children with cerebral palsy: a case control study. J Neuroeng Rehabil. 2018 Dec 10;15(1):115. doi: 10.1186/s12984-018-0467-7.

Reference Type DERIVED
PMID: 30526617 (View on PubMed)

Other Identifiers

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22173

Identifier Type: OTHER

Identifier Source: secondary_id

71002-PHI-14

Identifier Type: -

Identifier Source: org_study_id

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