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NCT Number: NCT07504640

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

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.

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Key information

Conditions

Cerebral Palsy (CP) Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elita Rehabilitation Center

Lviv, 79019, Ukraine

Location status: Recruiting

Location contact

Adrian Kuzan, MD

SUB_INVESTIGATOR

Anna Kushnir, MD

PRINCIPAL_INVESTIGATOR

Iryna Ablikova, PhD

SUB_INVESTIGATOR

Oleh O Kachmar, MD, PhD

CONTACT

[email protected]

00380673537927

About this study

Participants with cerebral palsy will undergo four experimental sessions on separate days in a randomized order. Each session will include either spinal manipulation or a sham intervention. Two sessions will involve spinal manipulation and two sessions will involve sham procedures.

Before and after each intervention, heart rate variability (HRV) will be measured under standardized conditions. The primary HRV parameter analyzed will be RMSSD, a time-domain measure reflecting vagal modulation of heart rate.

The crossover design allows each participant to serve as their own control, reducing inter-individual variability. The study focuses on the immediate autonomic effects of spinal manipulation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cerebral palsy
  • Motor function levels I-III according to GMFCS
  • Cooperative behavior

Exclusion criteria

  • Hyperkinetic forms
  • Use of medications affecting autonomic regulation

Treatment and study plan

Spinal manipulation

Procedure

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

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.

Primary outcomes

  1. Root Mean Square of Successive Differences (RMSSD)

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

    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.

Secondary outcomes

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

    Time frame: Immediately before and immediately after each intervention session

    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.

  2. Heart Rate (HR)

    Time frame: Immediately before and immediately after each intervention session

    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.

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

    Time frame: Immediately before and immediately after each intervention session

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Oleh Kachmar, MD, PhD

CONTACT

[email protected]

00380673537927

Sponsors and collaborators

Lead sponsor

International Clinic of Rehabilitation, Ukraine

Other

Collaborators

  • Elita Rehabilitation Center

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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