- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05355883
Remote Ischemic Conditioning, Bimanual Skill Learning, and Corticospinal Excitability
Effects of Remote Ischemic Conditioning on Bimanual Skill Learning, Bimanual Coordination, and Corticospinal Excitability in Children With Unilateral Cerebral Palsy
Study Overview
Status
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Swati Surkar, PT, PhD
- Phone Number: 2527446244
- Email: surkars19@ecu.edu
Study Locations
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-
North Carolina
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Greenville, North Carolina, United States, 27834
- Recruiting
- Dept. of Physical Therapy, East Carolina University
-
Contact:
- Swati Surkar
- Phone Number: 402-714-2640
- Email: surkars19@ecu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Children diagnosed with unilateral cerebral palsy, ages 6-16 years
- Manual Ability Classification System (MACS) levels I-III
- Ability to complete a stack of 3 cups in 2 minutes
- Mainstream in school and has sufficient cognition to follow the experiment instructions
Exclusion Criteria:
Children with other developmental disabilities such as autism, developmental coordination disorders, etc.
- Children with absent active motor threshold
- Children with cognitive deficits or communication problem
- Children with known cardiorespiratory and vascular dysfunctions
- Children with metabolic disorders, neoplasm, hydrocephalus
- Children who are receiving other adjunct therapies such as rTMS and tDCS
- Children with seizures and on anti-seizure medications
- Children with metal implants and incompatible medical devices for MRI scans
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Remote Ischemic Conditioning (RIC)
RIC is achieved via blood pressure cuff inflation to at least 20 mmHg above systolic blood pressure to 250 mmHg on the more involved arm. RIC involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. RIC is performed on visits 2-6. Intervention
|
See descriptions under arm/group descriptions.
RIC is delivered for 5 intervention visits.
Visits 1 is the pre-training assessment visit, visits 2-6 are RIC plus training visits, visit 7 is a post-training assessment visit.
Other Names:
HABIT is a child-friendly, intensive intervention directed at improving bimanual coordination and function of the affected arm.
The intervention employed in this study includes various age-appropriate fine and gross motor bimanual activities that will be delivered in a play context.
Children practice bimanual activities for 6 hours per day, 5 days per week, for 1 week.
Other Names:
Children practices bimanual cup stacking, 15 trials/day for 5 consecutive day.
Other Names:
All children undergo training on a balance board, learning to hold the board level with equal weight on each leg and using various bilateral upper extremity strategies.
Participants perform the balance task for 15, 30-second trials per day at visits 2-6.
|
Sham Comparator: Sham Conditioning
Sham conditioning is achieved via blood pressure cuff inflation to 25 mmHg on the more involved arm. RIC involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. RIC is performed on visits 2-6. Intervention
|
HABIT is a child-friendly, intensive intervention directed at improving bimanual coordination and function of the affected arm.
The intervention employed in this study includes various age-appropriate fine and gross motor bimanual activities that will be delivered in a play context.
Children practice bimanual activities for 6 hours per day, 5 days per week, for 1 week.
Other Names:
Children practices bimanual cup stacking, 15 trials/day for 5 consecutive day.
Other Names:
All children undergo training on a balance board, learning to hold the board level with equal weight on each leg and using various bilateral upper extremity strategies.
Participants perform the balance task for 15, 30-second trials per day at visits 2-6.
See descriptions under arm/group descriptions.
Sham conditioning is delivered for 5 intervention visits.
Visits 1 is the pre-training assessment visit, visits 2-6 are RIC plus training visits, visit 7 is a post-training assessment visit.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Assisting Hand Assessment
Time Frame: Baseline and 1 week
|
Assisting Hand Assessment assesses bimanual coordination and affected hand function.
A 5-point change from pre- to post-intervention is considered a clinically meaningful improvement.
|
Baseline and 1 week
|
Change in Bimanual Task Performance
Time Frame: Baseline and 1 week
|
The time (seconds) to complete each trial of cup stack, which will be averaged across three trials.
This will be measured at visit 1 (pre-) and visit 7 (post-intervention).
Smaller time to complete the task indicates better performance.
|
Baseline and 1 week
|
Change in Resting and Active Motor Thresholds
Time Frame: Baseline and 1 week
|
The minimum intensity of the stimulator output required to produce an MEP of > 50 μV will be determined using maximum-likelihood parameter estimation by a sequential testing (ML-PEST) algorithm from the lesioned and non-lesioned cortex.
Greater reduction in resting and active motor threshold from pre- to post-intervention indicates greater corticospinal excitability.
|
Baseline and 1 week
|
Change in Stimulus-response curves
Time Frame: Baseline and 1 week
|
Suprathreshold intensities of 110%, 120%, 130%, 140%, and 150% of resting motor threshold will be administered randomly on the lesioned and non-lesioned cortex.
Greater motor evoked potential response at each of these intensities indicate greater corticospinal excitability.
|
Baseline and 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Box and Blocks Test (BBT)
Time Frame: Baseline and 1 week
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BBT is a standard test to assess manual speed.
Greater number of blocks transferred indicates greater manual speed.
|
Baseline and 1 week
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Change in Nine Hole Peg Test (NHPT)
Time Frame: Baseline and 1 week
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NHPT is a standard test to assess manual speed and dexterity.
Smaller time to complete NHPT indicates greater speed and dexterity.
|
Baseline and 1 week
|
Change in Jebsen Hand Function Test (JHFT)
Time Frame: Baseline and 1 week
|
JHFT assesses fine and gross hand and arm movements.
Smaller time to complete JHFT indicates better hand function.
|
Baseline and 1 week
|
Change in Balance performance
Time Frame: Baseline and 1 week
|
The average amount of time in seconds that a participant maintains the stability platform within ±5° of horizontal position during 15 trials of 30 seconds each.
The total score will range between 0-30 seconds.
Higher balance score indicates better balance performance.
Greater average balance time indicates better balance performance.
|
Baseline and 1 week
|
Change in Hand grip and pinch strength
Time Frame: Baseline and 1 week
|
Hand grip and pinch strength assesses hand muscle strength.
Greater hand and pinch strength indicates greater strength of hand muscles.
|
Baseline and 1 week
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Change in Short-Interval Intracortical Inhibition (SICI)
Time Frame: Baseline and 1 week
|
For SICI, a subthreshold (80% RMT) conditioning pulse to the motor hotspot will be applied followed by a suprathreshold (120% RMT) test pulse 3 milliseconds later.
Reduction in SICI indicates intracortical facilitation.
|
Baseline and 1 week
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Change in Intracortical Facilitation (ICF)
Time Frame: Baseline and 1 week
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For ICF, the interstimulus interval will increase to 12 milliseconds.
Greater ICF indicates greater intracortical facilitation.
|
Baseline and 1 week
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Change in accelerometry derived variables
Time Frame: Baseline and 1 week
|
Number of movements, use ratio, magnitude ratio, bilateral magnitude, and acceleration variability will be quantified using wrist worn accelerometers.
Greater values indicate better bimanual performance.
|
Baseline and 1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Swati Surkar, East Carolina University
Publications and helpful links
General Publications
- Surkar SM, Hoffman RM, Willett S, Flegle J, Harbourne R, Kurz MJ. Hand-Arm Bimanual Intensive Therapy Improves Prefrontal Cortex Activation in Children With Hemiplegic Cerebral Palsy. Pediatr Phys Ther. 2018 Apr;30(2):93-100. doi: 10.1097/PEP.0000000000000486.
- Dirnagl U, Becker K, Meisel A. Preconditioning and tolerance against cerebral ischaemia: from experimental strategies to clinical use. Lancet Neurol. 2009 Apr;8(4):398-412. doi: 10.1016/S1474-4422(09)70054-7.
- Gidday JM. Cerebral preconditioning and ischaemic tolerance. Nat Rev Neurosci. 2006 Jun;7(6):437-48. doi: 10.1038/nrn1927.
- Stetler RA, Leak RK, Gan Y, Li P, Zhang F, Hu X, Jing Z, Chen J, Zigmond MJ, Gao Y. Preconditioning provides neuroprotection in models of CNS disease: paradigms and clinical significance. Prog Neurobiol. 2014 Mar;114:58-83. doi: 10.1016/j.pneurobio.2013.11.005. Epub 2014 Jan 2.
- Kharbanda RK, Nielsen TT, Redington AN. Translation of remote ischaemic preconditioning into clinical practice. Lancet. 2009 Oct 31;374(9700):1557-65. doi: 10.1016/S0140-6736(09)61421-5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-001913
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ICF
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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