Remote Ischemic Conditioning and Spinal Reflex Modulation in Children With Cerebral Palsy

NCT07390760 | Recruiting DMC

• 1 other identifier: UMCIRB 25-000932
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Children With Cerebral Palsy

Keywords

Remote Ischemic Conditioning; Cerebral Palsy; Spinal Reflex Modulation; H-reflex; Balance Training

Outcome Measures

Primary Outcomes (2)

• 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.

  [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.

  [Time Frame: Baseline, Day 5]

Secondary Outcomes (1)

• Change in Balance Performance

  [Time Frame: Baseline, Day 5]

Study Arms (2)

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.

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.

Behavioral: Sham conditioning; Behavioral: Balance training

Interventions

Remote Ischemic Condtioning (RIC) BEHAVIORAL

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.

Remote Ischemic Conditioning (RIC)

Sham conditioning BEHAVIORAL

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.

Remote Ischemic Conditioning (RIC); Sham conditioning

Balance training BEHAVIORAL

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.

Sham conditioning

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27834, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Swati M Surkar, PhD

  East Carolina University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Swati M Surkar, PhD

CONTACT

2527446244; surkars19@ecu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are masked to group assignment (RLIC vs. Sham conditioning)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: July 28, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: After publishing the results of the study
• Access Criteria: Data will be made available upon request to the principal investigator.

Locations

US (1)