Children With Cerebral PalsyNCT07390760
Remote Ischemic Conditioning and Spinal Reflex Modulation in Children With Cerebral Palsy
A study testing Remote Ischemic Condtioning (RIC) and Balance training in people with Children With Cerebral Palsy, run by East Carolina University at 1 site in United States.
Trial summary
Remote ischemic conditioning (RIC) is a clinically feasible intervention involving brief, sublethal periods of ischemia followed by reperfusion that has been shown to enhance motor performance, strength, and balance when combined with training in healthy adults and individuals with neurological conditions. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Children With Cerebral Palsy
- What is being tested?
- Remote Ischemic Condtioning (RIC) and Balance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with cerebral palsy (CP) between the ages 8-17 years
- Gross motor function classification system levels I-III
- Mainstream in school and has sufficient cognition to follow the experiment instructions
Who cannot join
- Children with other developmental disabilities such as autism and developmental coordination disorders
- Children with cognitive deficits such as inability to understand and follow commands, substantially lower performance at grade level in school, and/or communication problems
- Children with balance disorders such as vestibular disorders, posterior fossa tumor etc.
- Children with known cardiorespiratory dysfunctions
- Children with sickle cell disease
- Children who are receiving other adjunct therapies such as transcranial magnetic stimulation, transcranial direct current stimulation, or vagal nerve stimulation
- Presence of lower extremity condition, injury, or surgery within last three months which could compromise conditioning and training.
- Participants who are pregnant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
East Carolina University
Greenville, North Carolina, 27834
Swati M Surkar, PhD, 4027142640, surkars19@ecu.edu
About this study
Official title: Effects of Remote Ischemic Conditioning (RIC) Combined With Balance Training on Spinal Reflex Modulation in Children With Cerebral Palsy
Remote ischemic conditioning (RIC) is a clinically feasible intervention involving brief, sublethal periods of ischemia followed by reperfusion that has been shown to enhance motor performance, strength, and balance when combined with training in healthy adults and individuals with neurological conditions. Although RIC is thought to influence neuroplasticity through neural, metabolic, and humoral pathways, its effects on spinal-level mechanisms remain poorly understood. Emerging evidence indicates that neuroplastic adaptations occur not only at the cortical level but also within the spinal cord. Moreover, altered spinal reflex excitability is associated with spasticity, balance impairments, and functional limitations in children with cerebral palsy (CP), yet the role of spinal reflex modulations in response to RIC and balance training remains under expplored in this population. Therefore, this study aims to investigate the effects of RIC combined with balance training on spinal reflex modulation in children with CP.
Read the detailed description
Remote ischemic conditioning (RIC) is a clinically feasible, non-invasive intervention that involves brief, sublethal periods of ischemia followed by reperfusion and has been shown to improve motor performance, strength, and balance when combined with training in healthy adults and individuals with neurological conditions. Evidence from animal and human studies suggests that RIC exerts neuroprotective effects through multifactorial mechanisms involving neural, metabolic, vascular, and humoral pathways, with emerging data indicating the involvement of peripheral and spinal pathways. Neuroplasticity in response to training is known to occur not only at the cortical level but also within spinal neural circuits, where altered spinal reflex excitability is associated with spasticity, balance impairments, and poor functional outcomes in children with cerebral palsy (CP). While balance and locomotor training have been shown to reduce spinal reflex excitability in this population, the effects of RIC on spinal reflex modulation remain largely unexplored. The specific aims of this study are to determine whether 1) RIC combined with balance training modulates spinal reflex excitability, as reflected by H-reflex measures, and 2) to examine whether RIC combined with balance training leads to greater improvements in balance performance compared to sham conditioning combined with training in children with CP.
In this study, 16 children with cerebral palsy (ages 8-17 years) will be recruited. They will be randomly allocated into two groups: (A) RIC and (B) Sham. The study will consist of five consecutive visits. During Visit 1, participants will undergo baseline testing of the soleus H-reflex using a DS8R stimulator. After baseline testing, they will complete the first training session, which will include one session of conditioning combined with balance training (15 trials per session) on a stability trainer (Lafayette, IN). Visits 2 to 5 will each consist of one session of conditioning and balance training (second to fifth training sessions). During Visit 5, following the training session, post-testing of the H-reflex will be conducted. The average of the first five trials of balance training on Visit 1 will be used as the pre-test balance performance, and the average of the last five trials of balance training on Visit 5 will be used as the post-test balance performance. Conditioning will be administered to the more affected lower extremity (thigh), and a pulse oximeter will be placed on the toe for monitoring.
It is hypothesized that, compared to sham conditioning, remote ischemic conditioning combined with balance training will result in greater reductions in H-reflex excitability and greater improvements in balance performance in children with cerebral palsy. This study will help clarify whether RIC induces spinal reflex modulations when paired with balance training, reflecting spinal-level neuroplasticity in children with CP. These findings may advance understanding of the spinal mechanisms underlying the therapeutic benefits of RIC and support its translation as an adjunct intervention in pediatric neurorehabilitation.
- Conditions
- Children With Cerebral Palsy
- Being tested
- Remote Ischemic Condtioning (RIC), Sham conditioning, Balance training
- Keywords
- Remote Ischemic Conditioning, Cerebral Palsy, Spinal Reflex Modulation, H-reflex, Balance Training
- 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 Condtioning (RIC)Behavioural
See descriptions under arm/group descriptions. RIC is delivered for 5 intervention visits. Visits 1 is the baseline assessment and training visit, and visits 2-4 are RIC plus training visits, Visit 5 is training and post assessment visit.
Sham conditioningBehavioural
See descriptions under arm/group descriptions. Sham conditioning is delivered for 5 intervention visits. Visits 1 is the baseline assessment visit, visits 2-5 are training visits, and visit 5 is training and post assessment visit.
Balance trainingBehavioural
All participants will undergo training on a balance board, learning to hold the board level within the 5- degree horizontal range. Participants perform the balance task for 15, 30-second trials per day at visits 1-5.
| 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 200 mmHg on the thigh of more affected lower extremity. 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 - 5. Receives: Behavioral: Remote Ischemic Condtioning (RIC); Behavioral: Sham conditioning |
| Sham conditioning | Sham comparator | Sham conditioning is achieved via blood pressure cuff inflation to 25 mm Hg on the thigh of the more affected LE. Sham involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. Sham conditioning is performed on visits 1-5. Receives: Behavioral: Sham conditioning; Behavioral: Balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal H-reflex amplitude (Hmax)
The maximal (peak) H-reflex amplitude will be determined from the recruitment (stimulus-response) curve. The Hmax amplitude provides an estimate of the number or proportion of motor neurons (MNs) activated from the total MN pool, reflecting spinal reflex modulations and spinal neuroplasticity.
Measured: [Time Frame: Baseline, Day 5]
Change in Hmax/ Mmax Ratio
The maximal H-reflex and maximal M-wave amplitudes will be determined from the recruitment curve procedure. Calculating the Hmax/Mmax ratio is a standardization method used to reduce variability in H-reflex amplitude across participants. This provides a better basis for comparison and a more reliable estimate of changes in spinal reflex modulations between participants.
Measured: [Time Frame: Baseline, Day 5]
Secondary outcomes (1)
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: [Time Frame: Baseline, Day 5]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start28 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
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 M Surkar, PhD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390760
- Sponsor's protocol ID
- UMCIRB 25-000932
- Status last verified
- Mar 2026
- First submitted
- 29 Jan 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remote Ischemic Conditioning (RIC) Combined With Balance Training on Spinal Reflex Modulation in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07390760
- Acronym / sponsor ID
- UMCIRB 25-000932
- Conditions
- Children With Cerebral Palsy
- Keywords
- Remote Ischemic Conditioning, Cerebral Palsy, Spinal Reflex Modulation, H-reflex, Balance Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Feb 2026 (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.
Remote ischemic conditioning (RIC) is a clinically feasible intervention involving brief, sublethal periods of ischemia followed by reperfusion that has been shown to enhance motor performance, strength, and balance when combined with training in healthy adults and individuals with neurological conditions. Although RIC is thought to influence neuroplasticity through neural, metabolic, and humoral pathways, its effects on spinal-level mechanisms remain poorly understood. Emerging evidence indicates that neuroplastic adaptations occur not only at the cortical level but also within the spinal cord. Moreover, altered spinal reflex excitability is associated with spasticity, balance impairments, and functional limitations in children with cerebral palsy (CP), yet the role of spinal reflex modulations in response to RIC and balance training remains under expplored in this population. Therefore, this study aims to investigate the effects of RIC combined with balance training on spinal reflex modulation in children with CP.
Detailed description
Remote ischemic conditioning (RIC) is a clinically feasible, non-invasive intervention that involves brief, sublethal periods of ischemia followed by reperfusion and has been shown to improve motor performance, strength, and balance when combined with training in healthy adults and individuals with neurological conditions. Evidence from animal and human studies suggests that RIC exerts neuroprotective effects through multifactorial mechanisms involving neural, metabolic, vascular, and humoral pathways, with emerging data indicating the involvement of peripheral and spinal pathways. Neuroplasticity in response to training is known to occur not only at the cortical level but also within spinal neural circuits, where altered spinal reflex excitability is associated with spasticity, balance impairments, and poor functional outcomes in children with cerebral palsy (CP). While balance and locomotor training have been shown to reduce spinal reflex excitability in this population, the effects of RIC on spinal reflex modulation remain largely unexplored. The specific aims of this study are to determine whether 1) RIC combined with balance training modulates spinal reflex excitability, as reflected by H-reflex measures, and 2) to examine whether RIC combined with balance training leads to greater improvements in balance performance compared to sham conditioning combined with training in children with CP.
In this study, 16 children with cerebral palsy (ages 8-17 years) will be recruited. They will be randomly allocated into two groups: (A) RIC and (B) Sham. The study will consist of five consecutive visits. During Visit 1, participants will undergo baseline testing of the soleus H-reflex using a DS8R stimulator. After baseline testing, they will complete the first training session, which will include one session of conditioning combined with balance training (15 trials per session) on a stability trainer (Lafayette, IN). Visits 2 to 5 will each consist of one session of conditioning and balance training (second to fifth training sessions). During Visit 5, following the training session, post-testing of the H-reflex will be conducted. The average of the first five trials of balance training on Visit 1 will be used as the pre-test balance performance, and the average of the last five trials of balance training on Visit 5 will be used as the post-test balance performance. Conditioning will be administered to the more affected lower extremity (thigh), and a pulse oximeter will be placed on the toe for monitoring.
It is hypothesized that, compared to sham conditioning, remote ischemic conditioning combined with balance training will result in greater reductions in H-reflex excitability and greater improvements in balance performance in children with cerebral palsy. This study will help clarify whether RIC induces spinal reflex modulations when paired with balance training, reflecting spinal-level neuroplasticity in children with CP. These findings may advance understanding of the spinal mechanisms underlying the therapeutic benefits of RIC and support its translation as an adjunct intervention in pediatric neurorehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic Conditioning (RIC) | Experimental | Behavioral: Remote Ischemic Condtioning (RIC), Behavioral: Sham conditioningRIC is achieved via blood pressure cuff inflation to at least 20 mmHg above systolic blood pressure to 200 mmHg on the thigh of more affected lower extremity. 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 - 5. |
| Sham conditioning | Sham comparator | Behavioral: Sham conditioning, Behavioral: Balance trainingSham conditioning is achieved via blood pressure cuff inflation to 25 mm Hg on the thigh of the more affected LE. Sham involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. Sham conditioning is performed on visits 1-5. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children diagnosed with cerebral palsy (CP) between the ages 8-17 years
- Gross motor function classification system levels I-III
- 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 and developmental coordination disorders
- Children with cognitive deficits such as inability to understand and follow commands, substantially lower performance at grade level in school, and/or communication problems
- Children with balance disorders such as vestibular disorders, posterior fossa tumor etc.
- Children with known cardiorespiratory dysfunctions
- Children with sickle cell disease
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 Condtioning (RIC)See descriptions under arm/group descriptions. RIC is delivered for 5 intervention visits. Visits 1 is the baseline assessment and training visit, and visits 2-4 are RIC plus training visits, Visit 5 is training and post assessment visit. | Behavioural | Remote Ischemic Conditioning (RIC) |
| Sham conditioningSee descriptions under arm/group descriptions. Sham conditioning is delivered for 5 intervention visits. Visits 1 is the baseline assessment visit, visits 2-5 are training visits, and visit 5 is training and post assessment visit. | Behavioural | Remote Ischemic Conditioning (RIC), Sham conditioning |
| Balance trainingAll participants will undergo training on a balance board, learning to hold the board level within the 5- degree horizontal range. Participants perform the balance task for 15, 30-second trials per day at visits 1-5. | Behavioural | Sham conditioning |
Primary outcome
Change in maximal H-reflex amplitude (Hmax)
Time frame: [Time Frame: Baseline, Day 5]
The maximal (peak) H-reflex amplitude will be determined from the recruitment (stimulus-response) curve. The Hmax amplitude provides an estimate of the number or proportion of motor neurons (MNs) activated from the total MN pool, reflecting spinal reflex modulations and spinal neuroplasticity.
Change in Hmax/ Mmax Ratio
Time frame: [Time Frame: Baseline, Day 5]
The maximal H-reflex and maximal M-wave amplitudes will be determined from the recruitment curve procedure. Calculating the Hmax/Mmax ratio is a standardization method used to reduce variability in H-reflex amplitude across participants. This provides a better basis for comparison and a more reliable estimate of changes in spinal reflex modulations between participants.
1 secondary outcome
Change in Balance Performance
Time frame: [Time Frame: Baseline, Day 5]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- 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.
Swati M Surkar, PhD 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 Condtioning (RIC) and Balance training in people with Children With 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 3 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: looking for participants now, as of the sponsor's last update on 24 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Swati M Surkar, PhD (2527446244, surkars19@ecu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximal H-reflex amplitude (Hmax) (time frame: [Time Frame: Baseline, Day 5]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.