Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Elita Rehabilitation Center | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal manipulation | Experimental | High-velocity, low-amplitude Spinal manipulation applied according to predefined clinical criteria in cervical, thoracic and lumbar regions of the spine . |
|
| Sham Procedure | Sham Comparator | Simulated procedure mimicking patient positioning and therapist contact without delivering a therapeutic thrust. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal manipulation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately before and immediately after each intervention session |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oleh Kachmar, MD, PhD | Contact | 00380673537927 | okachmar@ic.reha.lviv.ua |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elita Rehabilitation Center | Recruiting | Lviv | 79019 | Ukraine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020393 | Manipulation, Spinal |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sham Procedure | Other | 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. |
|
| 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. | 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. | Immediately before and immediately after each intervention session |