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Not yet recruiting Not applicable NCT07504640

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

No applicable phase (e.g. observational)
Conditions: Cerebral Palsy (CP)

Sponsor: International Clinic of Rehabilitation, Ukraine

trial.available_in: БГ
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.
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.
Who can participate
Inclusion Criteria: * Cerebral palsy * Motor function levels I-III according to GMFCS * Cooperative behavior Exclusion Criteria: * Hyperkinetic forms * Use of medications affecting autonomic regulation
Interventions
Spinal manipulation
PROCEDURE
Sham Procedure
OTHER
Locations 1
Ukraine (1)
Elita Rehabilitation Center
Lviv
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
4 Years
Maximum age
18 Years
Healthy volunteers
No
Start date
01.05.2026
Completion date
01.11.2026
Registry ID
NCT07504640
Source
clinicaltrials.gov
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