Back to resultsBalance Control in Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sensory Integration Testing
SR stimulation & Sensory integration testing
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Sensor Fusion, Stochastic Resonance Stimulation, Sensory deficits, Postural Control
Eligibility Criteria
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
Sites / Locations
- Temple UniversityRecruiting
- Shriners Hospital for ChildrenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Children with Cerebral palsy
Children with Typical Development
Arm Description
Sensory integration testing SR stimulation and Sensory integration testing
Sensory integration testing SR stimulation and Sensory integration testing
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Gain response
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.
Full Information
NCT ID
NCT02456376
First Posted
May 26, 2015
Last Updated
May 26, 2015
Sponsor
Temple University
Collaborators
Shriners Hospitals for Children, University of Delaware
1. Study Identification
Unique Protocol Identification Number
NCT02456376
Brief Title
Balance Control in Children With Cerebral Palsy
Official Title
Sensor Fusion for Balance Control in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Temple University
Collaborators
Shriners Hospitals for Children, University of Delaware
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Sensor Fusion, Stochastic Resonance Stimulation, Sensory deficits, Postural Control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Children with Cerebral palsy
Arm Type
Experimental
Arm Description
Sensory integration testing
SR stimulation and Sensory integration testing
Arm Title
Children with Typical Development
Arm Type
Active Comparator
Arm Description
Sensory integration testing
SR stimulation and Sensory integration testing
Intervention Type
Procedure
Intervention Name(s)
Sensory Integration Testing
Other Intervention Name(s)
Sensor Fusion paradigm
Intervention Description
Investigate how sensory information are integrated during upright stance when visual and body senses are challenged in a virtual reality environment
Intervention Type
Procedure
Intervention Name(s)
SR stimulation & Sensory integration testing
Intervention Description
Use SR stimulation to improve sensory integration when visual and body senses are challenged in a virtual reality environment
Primary Outcome Measure Information:
Title
Gain response
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Gain response
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anastasia Zarkou, PT, MS
Email
azarkou@udel.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Samuel CK Lee, PT, PhD
Email
slee@udel.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Jeka, PhD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung-Jae Hwang, PhD
Email
hwangsungjae@gmail.com
First Name & Middle Initial & Last Name & Degree
John Jeka, PhD
Facility Name
Shriners Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anastasia Zarkou, PT, MS
Phone
215-430-4000
Ext
5141
Email
azarkou@udel.edu
First Name & Middle Initial & Last Name & Degree
John Jeka, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
30526617
Citation
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.
Results Reference
derived
Learn more about this trial
Balance Control in Children With Cerebral Palsy
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