An interventional study of Bimanual Cup Stacking Training in Unilateral Cerebral Palsy, sponsored by East Carolina University. Completed at 1 site in United States. Open to participants aged 8 Years to 16 Years. Per ClinicalTrials.gov, last updated 2025-07-14.
Sponsored by East Carolina University · Not applicable, Interventional, and Treatment
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 bimanual skill training to enhance bimanual skill learning and to augment skill dependent plasticity in children with UCP.
Ischemic conditioning (IC) is a phenomenon of protecting the target organ from ischemia by directly exposing it to brief episodes of sublethal ischemia. RIC is a clinically feasible way of performing IC where episodes of ischemia and reperfusion are delivered with cyclic inflation and deflation of a blood pressure cuff on the arm or leg. Pre-clinical and preliminary clinical trials in humans show neuroprotective effects of RIC. Investigators prior work has shown that when paired with motor training, RIC enhances motor learning in healthy individuals. Based on these diversified benefits of RIC, the central hypothesis is that the multifactorial mechanisms of RIC can be harnessed as a priming agent to enhance motor learning and augment neuroplasticity in children with UCP. The Specific Aims are: 1) to determine the effects of RIC + training on bimanual skill learning and bimanual coordination, and 2) to determine the effects of RIC + training on corticospinal excitability in children with UCP. In this triple blind, randomized controlled trial, 46 children with UCP, ages 6-16 years will first undergo bimanual speed stack performance, functional upper extremity, and Transcranial Magnetic Stimulation assessments. Children will then undergo RIC/Sham conditioning plus training. Investigators will deliver RIC/sham conditioning via cyclic inflation and deflation of a pressure cuff on the paretic arm using a standard protocol. Training will involve 5 days (15 trials/day) of bimanual speed stack training for 5 days. The children will perform the same baseline assessments post-intervention. Investigators hypothesize that compared to sham conditioning + training, RIC + training will significantly enhance: 1) bimanual skill performance (decrease in movement time (sec) to complete bimanual speed stack task), 2) bimanual coordination and bimanual function (improvement in kinematic variables and increase in the Assisting Hand Assessment scores), 3) cortical excitability in the ipsilesional primary motor cortex (M1) (larger amplitude of motor evoked potentials and lower resting or active motor thresholds), and 4) reduce motor cortex inhibition (reduced short-interval intracortical inhibition and increase in intracortical facilitation in ipsilesional M1). The long-term goal is to develop effective interventions to improve function of children with UCP. Outcomes of this project will provide critical ingredients for designing Phase II trials that will determine the effects of RIC combined with different dose of intensive behavioral interventions to improve functional outcomes in children with UCP.
East Carolina University is the lead sponsor of 83 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
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 1-7.
Behavioral: Bimanual Cup Stacking Training
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 1-7.
Behavioral: Bimanual Cup Stacking Training
Children practices bimanual cup stacking, 15 trials/day for 5 consecutive days
Also known as: Remote limb ischemic conditioning, Sham conditioning
Change in Bimanual Learning
The time (seconds) to complete each trial of cup stack, which will be averaged across nine trials. This will be measured at visit 1 (pre-) and visit 7 (post-intervention).
Time frame: Baseline and 1 week
Change in Symmetric performance and tangential velocities
Symmetric performance is characterized as a time-lag between the affected and less affected arm during movement onset and task completion.
Time frame: Baseline and 1 week
Change in Resting Motor Threshold (rMT)
The rMT is the stimulator output required to produce a motor evoked potential (MEP) of \> 50 μV in at least 5/10 trials in FDI muscle.
Time frame: Baseline and 1 week
Change in Active Motor Threshold (aMT)
The aMT is the stimulator output required to produce a motor evoked potential (MEP) of \> 200 μV in FDI muscle during 30% of MVIC of FDI muscle using a pinch grip. aMT is a measure of motor cortex excitability.
Time frame: Baseline and 1 week
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.
Time frame: Baseline and 1 week
Change in Hand Trajectory
Hand trajectory is defined as the resultant 3D path length between the starting position and task completion.
Time frame: Baseline and 1 week
Change in Temporal coupling (normalized movement overlap time)
Normalized movement overlap time is calculated as the percentage of total task completion time that both hands are participating in the stacking sequence during bimanual coordination task
Time frame: Baseline and 1 week
Change in total participation time of each hand
Total participation time is calculated as the total amount of time the affected and the less affected hand participate in bimanual coordination task. A hand will be considered as participating in the task any time the wrist marker tangential velocity remains over 2.0 cm/s for at least 100 ms.
Time frame: Baseline and 1 week
Change in Goal Synchronization
Goal synchronization is defined as a time lag between the initiation of the affected compared to the unaffected arm
Time frame: Baseline and 1 week
Change in total task duration
Total task duration is defined as the duration from movement onset until the criteria for task completion is reached with both hands.
Time frame: Baseline and 1 week
Change in Stimulus response curve
stimulus-response curves will be constructed for the ipsilesional as well as contralesional M1 at intensities of 90%, 100%, 110%, 120%, 130%, 140%, and 150% of rMT (10 stimuli per intensity in random order). The peak-to-peak amplitude of MEPs and area under the curve of resultant MEPs to these intensities will be calculated.
Time frame: Baseline and 1 week
Change in Motor Evoked Potential (MEP) amplitude
The peak-to-peak amplitude of the EMG response from the affected as well as unaffected FDI muscle while stimulating the ipsilesional as well as contralesional motor cortex will be recorded at 100% rMT and averaged across 10 single-pulse trials. MEP amplitude indicates the strength of motor response to TMS.
Time frame: Baseline and 1 week
Change in Short-interval intracortical inhibition (SICI) and intracortical facilitation (ICF)
SICI and ICF will be obtained by applying a conditioning stimulus at 80% rMT intensity or AMT intensity followed by a test stimulus at 120% rMT intensity over the hot spot. The interstimulus interval between the conditioning and test stimulus will be 3 ms for obtaining measures of SICI and 15 ms for obtaining ICF.
Time frame: Baseline and 1 week
Plan to share: Undecided — Data will be shared on NIH figshare network and will be made available on request.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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East Carolina University