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

May 27, 2026 updated by: Oleh Kachmar, International Clinic of Rehabilitation, Ukraine

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ukraine
      • Lviv, Ukraine, 79019
        • Recruiting
        • Elita Rehabilitation Center
        • Contact:
        • Principal Investigator:
          • Anna Kushnir, MD
        • Sub-Investigator:
          • Iryna Ablikova, PhD
        • Sub-Investigator:
          • Adrian Kuzan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Hyperkinetic forms
  • Use of medications affecting autonomic regulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spinal manipulation
High-velocity, low-amplitude Spinal manipulation applied according to predefined clinical criteria in cervical, thoracic and lumbar regions of the spine .
Procedure: Spinal manipulation
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 Comparator: Sham Procedure
Simulated procedure mimicking patient positioning and therapist contact without delivering a therapeutic thrust.
Other: Sham Procedure
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Immediately before and immediately after each intervention session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately before and immediately after each intervention session
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.
Immediately before and immediately after each intervention session
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.
Immediately before and immediately after each intervention session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Clinic of Rehabilitation, Ukraine

Collaborators

Elita Rehabilitation Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Kachmar, O.O., Kozyavkinа N.V., A.D. Kushnir, O.V. Kozyavkina, D.V. Popovych, N. Zeniou, and A.M. Kuzan. 2025. "The Effect of Spinal Manipulation on Heart Rate Variability in Children With Cerebral Palsy: A Pilot Study". INTERNATIONAL NEUROLOGICAL JOURNAL 21 (6):470-75.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

April 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-10 (Kangdong Sacred Heart Hospital Fund)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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