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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-17
SponsorEast Carolina University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: Remote Ischemic Conditioning (RIC)Experimental treatment 2 interventions
Group B: Sham conditioningSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

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
[Time Frame: Baseline, Day 5]
2

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
[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.

Time frame
[Time Frame: Baseline, Day 5]

Other outcomes

Sponsors and contacts

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