NCT07504640

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
May 2026Nov 2026

First Submitted

Initial submission to the registry

March 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

April 17, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 26, 2026

Last Update Submit

April 14, 2026

Conditions

Cerebral Palsy (CP)

Keywords

Heart rate variabilityspinal manipulationcerebral palsy

Outcome Measures

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: Immediately before and immediately after each intervention session

Secondary Outcomes (3)

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

    Immediately before and immediately after each intervention session

  • Heart Rate (HR)

    Immediately before and immediately after each intervention session

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

    Immediately before and immediately after each intervention session

Study Arms (2)

Spinal manipulation

EXPERIMENTAL

High-velocity, low-amplitude Spinal manipulation applied according to predefined clinical criteria in cervical, thoracic and lumbar regions of the spine .

Procedure: Spinal manipulation

Sham Procedure

SHAM COMPARATOR

Simulated procedure mimicking patient positioning and therapist contact without delivering a therapeutic thrust.

Other: Sham Procedure

Interventions

Spinal manipulationPROCEDURE

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.

Spinal manipulation
Sham ProcedureOTHER

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.

Sham Procedure

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Hyperkinetic forms
  • Use of medications affecting autonomic regulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elita Rehabilitation Center

Lviv, 79019, Ukraine

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitation

Central Study Contacts

Oleh Kachmar, MD, PhD

CONTACT

00380673537927okachmar@ic.reha.lviv.ua

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 26, 2026

First Posted

April 1, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

April 17, 2026

Record last verified: 2026-03

Locations

UA(1)