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Recruiting NCT07504640

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

No phase Interventional Cerebral Palsy (CP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spinal manipulation, Sham Procedure.
Who it may be relevant to
Registry conditions: Cerebral Palsy (CP). Basic parameters: 4 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Ukraine
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Root Mean Square of Successive Differences (RMSSD) [Time frame: Time Frame: Immediately before and immediately after each intervention session]
Secondary outcome measures (3)
  • Standard Deviation of Normal-to-Normal Intervals (SDNN) [Time frame: Immediately before and immediately after each intervention session]
  • Heart Rate (HR) [Time frame: 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Hyperkinetic forms
  • Use of medications affecting autonomic regulation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Basic science

Study locations

Ukraine · 1 center
  • Elita Rehabilitation Center — Lviv

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.

Identifiers

NCT: NCT07504640 · 2025-10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗