Cerebral Palsy (CP)NCT07504640
The Effect of Spinal Manipulation on Heart Rate Variability in Children With Cerebral Palsy.
A study testing Spinal manipulation in people with Cerebral Palsy (CP), run by International Clinic of Rehabilitation, Ukraine at 1 site in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Spinal manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUkraine
- Study dates
- 1 May 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Cerebral palsy
- Motor function levels I-III according to GMFCS
- Cooperative behavior
Who cannot join
- Hyperkinetic forms
- Use of medications affecting autonomic regulation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ukraine1 site, 1 recruiting
- Recruiting
Elita Rehabilitation Center
Lviv, 79019
Oleh O Kachmar, MD, PhD, 00380673537927, okachmar@ic.reha.lviv.ua
Anna Kushnir, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Spinal manipulation, Sham Procedure
- Keywords
- Heart rate variability, spinal manipulation, cerebral palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal manipulationProcedure or surgery
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Spinal manipulation | Experimental | High-velocity, low-amplitude Spinal manipulation applied according to predefined clinical criteria in cervical, thoracic and lumbar regions of the spine . Receives: Procedure: Spinal manipulation |
| Sham Procedure | Sham comparator | Simulated procedure mimicking patient positioning and therapist contact without delivering a therapeutic thrust. Receives: Other: Sham Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time Frame: Immediately before and immediately after each intervention session
Secondary outcomes (3)
Standard Deviation of Normal-to-Normal Intervals (SDNN)
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.
Measured: Immediately before and immediately after each intervention session
Heart Rate (HR)
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.
Measured: Immediately before and immediately after each intervention session
Low Frequency/High Frequency Ratio (LF/HF Ratio)
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.
Measured: Immediately before and immediately after each intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 May 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Clinic of Rehabilitation, Ukraine
- Sponsor type
- University, hospital or other
- Collaborators
- Elita Rehabilitation Center
- Responsible party
- Principal investigator, Oleh Kachmar, International Clinic of Rehabilitation, Ukraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504640
- Sponsor's protocol ID
- 2025-10
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Spinal Manipulation on Heart Rate Variability in Children With Cerebral Palsy. Randomised Comtrolled Trial
- ClinicalTrials.gov ID
- NCT07504640
- Acronym / sponsor ID
- 2025-10
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Heart rate variability, spinal manipulation, cerebral palsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- International Clinic of Rehabilitation, UkraineUniversity, hospital or other
- Collaborators
- Elita Rehabilitation Center
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal manipulation | Experimental | Procedure: Spinal manipulationHigh-velocity, low-amplitude Spinal manipulation applied according to predefined clinical criteria in cervical, thoracic and lumbar regions of the spine . |
| Sham Procedure | Sham comparator | Other: Sham ProcedureSimulated procedure mimicking patient positioning and therapist contact without delivering a therapeutic thrust. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Cerebral palsy
- Motor function levels I-III according to GMFCS
- Cooperative behavior
Key exclusion criteria (2 listed)
- Hyperkinetic forms
- Use of medications affecting autonomic regulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal manipulationA 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. | Procedure or surgery | Spinal manipulation |
| Sham ProcedureThe 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. | Other | Sham Procedure |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- BackgroundKachmar, 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal manipulation in people with Cerebral Palsy (CP), run by International Clinic of Rehabilitation, Ukraine at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oleh Kachmar, MD, PhD (00380673537927, okachmar@ic.reha.lviv.ua), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root Mean Square of Successive Differences (RMSSD) (time frame: Time Frame: Immediately before and immediately after each intervention session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07504640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.