Unilateral Cerebral PalsyNCT05355883
Remote Ischemic Conditioning, Bimanual Skill Learning, and Corticospinal Excitability
A study testing Remote Ischemic Conditioning (RIC), Hand Arm Bimanual Intensive Therapy (HABIT) and Bimanual Cup Stacking Training in people with Unilateral Cerebral Palsy and Hemiplegic Cerebral Palsy, run by East Carolina University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Unilateral Cerebral Palsy, Hemiplegic Cerebral Palsy, Remote Ischemic Conditioning
- What is being tested?
- Remote Ischemic Conditioning (RIC), Hand Arm Bimanual Intensive Therapy (HABIT) and Bimanual Cup Stacking Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2021to 30 May 2025
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dept. of Physical Therapy, East Carolina University
Greenville, North Carolina, 27834
About this study
Official title: Effects of Remote Ischemic Conditioning on Bimanual Skill Learning, Bimanual Coordination, and Corticospinal Excitability in Children With Unilateral Cerebral Palsy
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.
Read the detailed description
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 performance, and 2) to determine the effects of RIC + training on corticospinal excitability in children with UCP. In this triple blind, randomized controlled trial, 30 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 and intensive bimanual training using hand arm bimanual intensive therapy (HABIT) with a standard dose of 6 hours/day 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 function (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.
- Being tested
- Remote Ischemic Conditioning (RIC), Sham conditioning, Hand Arm Bimanual Intensive Therapy (HABIT), Bimanual Cup Stacking Training, Balance training
- Keywords
- Cerebral palsy, Bimanual coordination, Corticospinal excitability
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic Conditioning (RIC)Behavioural
Also called Remote limb ischemic conditioning
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.
Sham conditioningBehavioural
Also called Sham
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.
Hand Arm Bimanual Intensive Therapy (HABIT)Behavioural
Also called Bimanual skill training
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.
Bimanual Cup Stacking TrainingBehavioural
Also called Cup stacking task
Children practices bimanual cup stacking, 15 trials/day for 5 consecutive day.
Balance trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischemic Conditioning (RIC) | Experimental | 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
* Hand Arm Bimanual Intensive Therapy (HABIT)
* Bimanual cup stacking training
* Balance training Receives: Behavioral: Remote Ischemic Conditioning (RIC); Behavioral: Hand Arm Bimanual Intensive Therapy (HABIT); Behavioral: Bimanual Cup Stacking Training; Behavioral: Balance training |
| Sham Conditioning | Sham comparator | 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
* Hand Arm Bimanual Intensive Therapy (HABIT)
* Bimanual cup stacking training
* Balance training Receives: Behavioral: Sham conditioning; Behavioral: Hand Arm Bimanual Intensive Therapy (HABIT); Behavioral: Bimanual Cup Stacking Training; Behavioral: Balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 week
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.
Measured: Baseline and 1 week
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.
Measured: Baseline and 1 week
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.
Measured: Baseline and 1 week
Secondary outcomes (8)
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.
Measured: Baseline and 1 week
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.
Measured: Baseline and 1 week
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.
Measured: Baseline and 1 week
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.
Measured: Baseline and 1 week
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.
Measured: Baseline and 1 week
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.
Measured: Baseline and 1 week
Change in Intracortical Facilitation (ICF)
For ICF, the interstimulus interval will increase to 12 milliseconds. Greater ICF indicates greater intracortical facilitation.
Measured: Baseline and 1 week
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.
Measured: Baseline and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start18 Dec 2021
- Primary completion31 Dec 2024
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Unilateral 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded, randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Swati Manoharrao Surkar, East Carolina University
- Investigators
- Swati Surkar, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355883
- Sponsor's protocol ID
- 21-001913
- Status last verified
- Jul 2025
- First submitted
- 15 Jan 2022
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared on NIH figshare network and will be made available on request.
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.
PubMed 29578992Dirnagl 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.
PubMed 19296922Gidday JM. Cerebral preconditioning and ischaemic tolerance. Nat Rev Neurosci. 2006 Jun;7(6):437-48. doi: 10.1038/nrn1927.
PubMed 16715053Stetler 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.
PubMed 24389580Kharbanda 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.
PubMed 19880021
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remote Ischemic Conditioning on Bimanual Skill Learning, Bimanual Coordination, and Corticospinal Excitability in Children With Unilateral Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05355883
- Acronym / sponsor ID
- 21-001913
- Keywords
- Cerebral palsy, Bimanual coordination, Corticospinal excitability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 18 Dec 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 2 May 2022 (actual)
- 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.
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.
Detailed description
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 performance, and 2) to determine the effects of RIC + training on corticospinal excitability in children with UCP. In this triple blind, randomized controlled trial, 30 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 and intensive bimanual training using hand arm bimanual intensive therapy (HABIT) with a standard dose of 6 hours/day 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 function (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic Conditioning (RIC) | Experimental | Behavioral: Remote Ischemic Conditioning (RIC), Behavioral: Hand Arm Bimanual Intensive Therapy (HABIT), Behavioral: Bimanual Cup Stacking Training, Behavioral: Balance trainingRIC 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 * Hand Arm Bimanual Intensive Therapy (HABIT) * Bimanual cup stacking training * Balance training |
| Sham Conditioning | Sham comparator | Behavioral: Sham conditioning, Behavioral: Hand Arm Bimanual Intensive Therapy (HABIT), Behavioral: Bimanual Cup Stacking Training, Behavioral: Balance trainingSham 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 * Hand Arm Bimanual Intensive Therapy (HABIT) * Bimanual cup stacking training * Balance training |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Children with other developmental disabilities such as autism, developmental coordination disorders, etc.
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 |
|---|---|---|
| Remote Ischemic Conditioning (RIC)Also: Remote limb ischemic conditioningSee 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. | Behavioural | Remote Ischemic Conditioning (RIC) |
| Sham conditioningAlso: ShamSee 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. | Behavioural | Sham Conditioning |
| Hand Arm Bimanual Intensive Therapy (HABIT)Also: Bimanual skill trainingHABIT 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. | Behavioural | Remote Ischemic Conditioning (RIC), Sham Conditioning |
| Bimanual Cup Stacking TrainingAlso: Cup stacking taskChildren practices bimanual cup stacking, 15 trials/day for 5 consecutive day. | Behavioural | Remote Ischemic Conditioning (RIC), Sham Conditioning |
| Balance trainingAll 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. | Behavioural | Remote Ischemic Conditioning (RIC), Sham Conditioning |
Primary outcome
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.
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.
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.
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.
8 secondary outcomes
Change in Box and Blocks Test (BBT)
Time frame: Baseline and 1 week
Change in Nine Hole Peg Test (NHPT)
Time frame: Baseline and 1 week
Change in Jebsen Hand Function Test (JHFT)
Time frame: Baseline and 1 week
Change in Balance performance
Time frame: Baseline and 1 week
Change in Hand grip and pinch strength
Time frame: Baseline and 1 week
Change in Short-Interval Intracortical Inhibition (SICI)
Time frame: Baseline and 1 week
Change in Intracortical Facilitation (ICF)
Time frame: Baseline and 1 week
Change in accelerometry derived variables
Time frame: Baseline and 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Background: PubMed 29578992Surkar 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.
- Background: PubMed 19296922Dirnagl 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.
- Background: PubMed 16715053Gidday JM. Cerebral preconditioning and ischaemic tolerance. Nat Rev Neurosci. 2006 Jun;7(6):437-48. doi: 10.1038/nrn1927.
- Background: PubMed 24389580Stetler 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.
- Background: PubMed 19880021Kharbanda 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.
- Individual participant dataSharing planned: Yes. Data will be shared on NIH figshare network and will be made available on request.
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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.
Swati Surkar principal investigator
East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic Conditioning (RIC), Hand Arm Bimanual Intensive Therapy (HABIT) and Bimanual Cup Stacking Training in people with Unilateral Cerebral Palsy and Hemiplegic Cerebral Palsy, run by East Carolina University at 1 site 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Assisting Hand Assessment (time frame: Baseline and 1 week). The study lists 4 primary outcomes in all. 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 NCT05355883, which also lists 5 linked publications.
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 16 Jul 2025.