Recruiting

RIC & Balance Training

Sponsor:

East Carolina University

Code:

NCT07390760

Conditions

Children With Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Interventions

Remote Ischemic Condtioning (RIC)

Sham conditioning

Balance training

Study Details

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

Study ID

NCT07390760

Start date

Jul 28, 2025

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Remote Ischemic Conditioning (RIC)

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.

sham comparator: Sham conditioning

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.

Interventions

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.

Sham conditioning

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 training

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.

Primary outcome measure

  • Change in maximal H-reflex amplitude (Hmax) [ Time Frame: [Time Frame: Baseline, Day 5] ]
  • Change in Hmax/ Mmax Ratio [ Time Frame: [Time Frame: Baseline, Day 5] ]

Central Contacts and Locations

Central contacts

Swati M Surkar, PhD

2527446244surkars19@ecu.edu

Locations

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Swati M Surkar, PhD

4027142640surkars19@ecu.edu

More Information

Sponsor

East Carolina University

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by East Carolina University on 2026-03-24.