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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05355883
Other study ID # 21-001913
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 18, 2021
Est. completion date December 31, 2024

Study information

Verified date April 2022
Source East Carolina University
Contact Swati Surkar, PT, PhD
Phone 2527446244
Email surkars19@ecu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Unilateral cerebral palsy (UCP) is a leading cause of childhood disability. An early brain injury impairs the upper extremity function, bimanual coordination, and impacts the child's independence. The existing therapeutic interventions have higher training doses and modest effect sizes. Thus, there is a critical need to find an effective priming agent to enhance bimanual skill learning in children with UCP. This study aims to determine the effects of a novel priming agent, remote ischemic conditioning (RIC), when paired with intensive bimanual skill training to enhance bimanual skill learning and to augment skill dependent plasticity in children with UCP.


Description:

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Study Design


Intervention

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Locations

Country Name City State
United States Dept. of Physical Therapy, East Carolina University Greenville North Carolina

Sponsors (1)

Lead Sponsor Collaborator
East Carolina University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Review. — View Citation

Gidday JM. Cerebral preconditioning and ischaemic tolerance. Nat Rev Neurosci. 2006 Jun;7(6):437-48. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Assisting Hand Assessment 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
Primary Change in Bimanual Task Performance 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
Primary Change in Resting and Active Motor Thresholds 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
Primary Change in Stimulus-response curves 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 Change in Box and Blocks Test (BBT) BBT is a standard test to assess manual speed. Greater number of blocks transferred indicates greater manual speed. Baseline and 1 week
Secondary Change in Nine Hole Peg Test (NHPT) 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
Secondary Change in Jebsen Hand Function Test (JHFT) JHFT assesses fine and gross hand and arm movements. Smaller time to complete JHFT indicates better hand function. Baseline and 1 week
Secondary Change in Balance performance 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
Secondary Change in Hand grip and pinch strength Hand grip and pinch strength assesses hand muscle strength. Greater hand and pinch strength indicates greater strength of hand muscles. Baseline and 1 week
Secondary Change in Short-Interval Intracortical Inhibition (SICI) 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
Secondary Change in Intracortical Facilitation (ICF) For ICF, the interstimulus interval will increase to 12 milliseconds. Greater ICF indicates greater intracortical facilitation. Baseline and 1 week
Secondary Change in accelerometry derived variables 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
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