Cerebral Palsy (CP)
Conditions
Keywords
Heart rate variability, spinal manipulation, cerebral palsy
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.
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
PROCEDURESpinal 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.
OTHERSham 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.
Sponsors
International Clinic of Rehabilitation, Ukraine
Elita Rehabilitation Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Cerebral palsy * Motor function levels I-III according to GMFCS * Cooperative behavior
Exclusion criteria
* Hyperkinetic forms * Use of medications affecting autonomic regulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Root Mean Square of Successive Differences (RMSSD) | 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
| Measure | Time frame | Description |
|---|---|---|
| Standard Deviation of Normal-to-Normal Intervals (SDNN) | 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. |
| Heart Rate (HR) | 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. |
| Low Frequency/High Frequency Ratio (LF/HF Ratio) | 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. |
Countries
Ukraine
Contacts
CONTACTOleh Kachmar, MD, PhD
Outcome results
None listed