Cerebral PalsyNCT02456376
Balance Control in Children With Cerebral Palsy
A study testing Sensory Integration Testing and SR stimulation & Sensory integration testing in people with Cerebral Palsy, run by Temple University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Sensory Integration Testing and SR stimulation & Sensory integration testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Diagnosis of spastic diplegia CP (GMFCS I- III)*
- Ability to stand independently for approximately 2 min
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Anastasia Zarkou, PT, MS contact
Samuel CK Lee, PT, PhD contact
United States2 sites, 2 recruiting
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19122
Sung-Jae Hwang, PhD, hwangsungjae@gmail.com
John Jeka, PhD
- Recruiting
Shriners Hospital for Children
Philadelphia, Pennsylvania, 19140
Anastasia Zarkou, PT, MS, 215-430-4000 ext. 5141, azarkou@udel.edu
John Jeka, PhD
About this study
Official title: 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.
- Conditions
- Cerebral Palsy
- Being tested
- Sensory Integration Testing, SR stimulation & Sensory integration testing
- Keywords
- Sensor Fusion, Stochastic Resonance Stimulation, Sensory deficits, Postural Control
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Integration TestingProcedure or surgery
Also called Sensor Fusion paradigm
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 testingProcedure or surgery
Use SR stimulation to improve sensory integration when visual and body senses are challenged in a virtual reality environment
| Study group | Role | What they receive |
|---|---|---|
| Children with Cerebral palsy | Experimental | 1. Sensory integration testing
2. SR stimulation and Sensory integration testing Receives: Procedure: Sensory Integration Testing; Procedure: SR stimulation & Sensory integration testing |
| Children with Typical Development | Active comparator | 1. Sensory integration testing
2. SR stimulation and Sensory integration testing Receives: Procedure: Sensory Integration Testing; Procedure: SR stimulation & Sensory integration testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startMay 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Shriners Hospitals for Children, University of Delaware
- Responsible party
- Principal investigator, John Jeka, Temple University
- Investigators
- John Jeka, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456376
- Sponsor's protocol ID
- 71002-PHI-14
- Other IDs
- 22173
- Status last verified
- May 2015
- First submitted
- 26 May 2015
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30526617
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensor Fusion for Balance Control in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02456376
- Acronym / sponsor ID
- 71002-PHI-14
- Conditions
- Cerebral Palsy
- Keywords
- Sensor Fusion, Stochastic Resonance Stimulation, Sensory deficits, Postural Control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Shriners Hospitals for Children, University of Delaware
- Study start
- May 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Cerebral palsy | Experimental | Procedure: Sensory Integration Testing, Procedure: SR stimulation & Sensory integration testing1. Sensory integration testing 2. SR stimulation and Sensory integration testing |
| Children with Typical Development | Active comparator | Procedure: Sensory Integration Testing, Procedure: SR stimulation & Sensory integration testing1. Sensory integration testing 2. SR stimulation and Sensory integration testing |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosis of spastic diplegia CP (GMFCS I- III)*
- Ability to stand independently for approximately 2 min
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory Integration TestingAlso: Sensor Fusion paradigmInvestigate how sensory information are integrated during upright stance when visual and body senses are challenged in a virtual reality environment | Procedure or surgery | Children with Cerebral palsy, Children with Typical Development |
| SR stimulation & Sensory integration testingUse SR stimulation to improve sensory integration when visual and body senses are challenged in a virtual reality environment | Procedure or surgery | Children with Cerebral palsy, Children with Typical Development |
Primary outcome
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 secondary outcome
Gain response
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Derived from this study: PubMed 30526617Zarkou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anastasia Zarkou, PT, MS contact
Samuel CK Lee, PT, PhD contact
John Jeka, PhD principal investigator
Temple University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Integration Testing and SR stimulation & Sensory integration testing in people with Cerebral Palsy, run by Temple University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anastasia Zarkou, PT, MS (azarkou@udel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gain response (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02456376, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.