NCT02456376

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

2.6 years

First QC Date

May 26, 2015

Last Update Submit

May 26, 2015

Conditions

Cerebral Palsy

Keywords

Sensor FusionStochastic Resonance StimulationSensory deficitsPostural Control

Outcome Measures

Primary Outcomes (1)

  • Gain response

    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 Outcomes (1)

  • Gain response

    1 day

Study Arms (2)

Children with Cerebral palsy

EXPERIMENTAL

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

Procedure: Sensory Integration TestingProcedure: SR stimulation & Sensory integration testing

Children with Typical Development

ACTIVE COMPARATOR

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

Procedure: Sensory Integration TestingProcedure: SR stimulation & Sensory integration testing

Interventions

Sensory Integration TestingPROCEDURE

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

Also known as: Sensor Fusion paradigm
Children with Cerebral palsyChildren with Typical Development
SR stimulation & Sensory integration testingPROCEDURE

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

Children with Cerebral palsyChildren with Typical Development

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Temple University

Philadelphia, Pennsylvania, 19122, United States

RECRUITING

Shriners Hospital for Children

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30526617DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • John Jeka, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anastasia Zarkou, PT, MS

CONTACT

azarkou@udel.edu

Samuel CK Lee, PT, PhD

CONTACT

slee@udel.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 26, 2015

First Posted

May 28, 2015

Study Start

May 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

US(2)