Health TrialsbyHealthPanel

The Effect of Spinal Manipulation on Heart Rate Variability in Children With Cerebral Palsy.

ConditionCerebral Palsy (CP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-18
SponsorInternational Clinic of Rehabilitation, Ukraine

About this trial

This randomized, sham-controlled crossover trial aims to evaluate the immediate effects of spinal manipulation on heart rate variability in children with cerebral palsy. Each participant will attend four experimental sessions conducted on separate days. In two sessions, spinal manipulation will be performed, and in two sessions, a sham procedure will be applied. The order of interventions will be randomized for each participant. Heart rate variability will be recorded before and after each intervention.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cerebral palsy

Motor function levels I-III according to GMFCS

Cooperative behavior

Disqualifiers

Hyperkinetic forms

Use of medications affecting autonomic regulation

Trial design

Design model

Crossover

Treatments tested in this trial

  • Spinal manipulation

    Procedure/Surgery

    A high-velocity, low-amplitude (HVLA) spinal manipulation will be delivered to the cervical, thoracic and lumbar regions of the spine with the participant in a standardized position. The procedure will be performed by a licensed practitioner experienced in pediatric care. Each session will last approximately the same duration as the sham procedure.

  • Sham Procedure

    Other intervention

    The sham procedure will involve light manual contact and positioning similar to spinal manipulation but without the application of high-velocity, low-amplitude thrust or joint cavitation. This procedure is designed to control for tactile and contextual effects of the intervention while minimizing physiological impact. The duration and environment will match those of the active intervention sessions.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Spinal manipulationExperimental treatment 1 intervention
Group B: Sham ProcedureSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Root Mean Square of Successive Differences (RMSSD)

RMSSD will be calculated from short-term heart rate variability recordings obtained under standardized resting conditions. It reflects parasympathetic (vagal) modulation of heart rate. The primary outcome is the change in RMSSD from pre- to post-intervention within each session, comparing spinal manipulation and sham conditions.

Time frame
Time Frame: Immediately before and immediately after each intervention session

Secondary outcomes

1

Standard Deviation of Normal-to-Normal Intervals (SDNN)

SDNN will be derived from heart rate variability recordings and represents overall variability in heart rate, reflecting combined sympathetic and parasympathetic influences. The outcome will be the change in SDNN from pre- to post-intervention within each session.

Time frame
Immediately before and immediately after each intervention session
2

Heart Rate (HR)

Heart rate will be measured concurrently with heart rate variability recordings under standardized conditions. The outcome will be the change in heart rate from pre- to post-intervention within each session.

Time frame
Immediately before and immediately after each intervention session
3

Low Frequency/High Frequency Ratio (LF/HF Ratio)

The LF/HF ratio will be calculated from frequency-domain analysis of heart rate variability. It is commonly used as an index of sympathovagal balance. The outcome will be the change in LF/HF ratio from pre- to post-intervention within each session.

Time frame
Immediately before and immediately after each intervention session

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

International Clinic of Rehabilitation, Ukraine

Lead sponsor

Elita Rehabilitation Center

Collaborator

Source ClinicalTrials.gov
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