Cerebral Palsy, SpasticSpiManCPNCT03005938
Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Cerebral Palsy.
A study testing Spinal manipulation and Imitation of the spinal manipulation in people with Cerebral Palsy, Spastic, run by International Clinic of Rehabilitation, Ukraine at 1 site in Ukraine.
Trial summary
The aim of the study is to evaluate a short term influence of the Spinal Manipulation (SM) on the wrist muscles spasticity and manual dexterity in children with spastic Cerebral Palsy. Effect of SM and imitation of the SM has to be compared in the double-blinded randomized clinical trial. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Spinal manipulation and Imitation of the spinal manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteUkraine
- Study dates
- Sep 2016to 15 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Spastic uni-, bilateral Cerebral Palsy
- Manual Ability classification level (MACS) - I-III level
- Modified Ashworth scale (MAS) grade 1-3 in wrist or fingers flexors
Who cannot join
- Dyskinetic or ataxic syndrome
- Less than 40 degrees of passive wrist extension with fingers extended
- Botox injections in hand muscles during last year or recent antispastic drugs
- Fracture in hand or forearm less than 6 month prior to examination
- Uncooperative behavior, inability to understand and comply with instructions
- Severe pain preventing the child from being able to complete examinations
Trial locations and contacts
1 site in 1 country.
Ukraine1 site
International Clinic of Rehabilitation
Truskavets, Lviv Oblast, 82200
About this study
Official title: Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Children With Cerebral Palsy, Randomized Control Trial.
The aim of the study is to evaluate a short term influence of the Spinal Manipulation (SM) on the wrist muscles spasticity and manual dexterity in children with spastic Cerebral Palsy.
Effect of SM and imitation of the SM has to be compared in the double-blinded randomized clinical trial.
Read the detailed description
Muscle spasticity is an important clinical syndrome of Cerebral Palsy (CP) resulting from upper motor neuron lesion, and its reduction is a significant therapeutic target for optimizing motor performance.
Investigator's recent study describes decrease in spasticity after SM in a group of children with CP. But that case series has no control group and the sample size was small so it does not prove the influence of the SM on the muscle spasticity.
The purpose of the present study is to evaluate influence of the SM on muscle spasticity and on manual dexterity of the child with CP in a double-blind randomized clinical trial with two arms: SM (experimental group) and imitation of SM (control group).
Children admitted to the International Clinic of Rehabilitation are selected according to inclusion-exclusion criteria and invited to participate. After getting the permission the baseline assessment is performed.
Patients are allocated to the experimental or control group using stratified randomization. Medical doctor certified in Manual Therapy performs the intervention (SM in the experimental group and imitation in the control group) and in 15 minutes the second assessment is performed. Investigators, children and parents are blinded to group allocation.
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- Spinal manipulation, Imitation of the spinal manipulation
- Keywords
- Cerebral Palsy, Spinal Manipulation, Muscle Spasticity, Manual Dexterity
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal manipulationProcedure or surgery
Also called Biomechanical correction of the spine
Spinal manipulation (SM) is a therapeutic intervention performed on spinal articulations in which force is applied to the spine. The selected joint is moved to its end range of motion, followed by application of an rapid impulse or thrust to achieve a gapping of the target joint.
SM is performed by an orthopedic medical doctor certified in Manual Therapy. After manual evaluation, high-velocity low-amplitude SM is carried out in all regions of the spine, including thoracic adjustments in the prone position, lumbar manipulation in lateral recumbent position, and cervical manipulation in sitting position.
Imitation of the spinal manipulationProcedure or surgery
Also called Sham manipulation
Imitation of the SM physically and visually resembles the act of SM. It comprises placing the patient in the same positions and performing the same movements as during SM but without applying the force in the end range of motion.
| Study group | Role | What they receive |
|---|---|---|
| Spinal manipulation | Experimental | Spinal manipulation Receives: Procedure: Spinal manipulation |
| Imitation of the spinal manipulation | Sham comparator | Imitation of the spinal manipulation Receives: Procedure: Imitation of the spinal manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of muscle spasticity after the intervention
Quantitative, instrumental spasticity measurement is preformed using the Neuroflexor device. It is measuring resistance to passive movements of the wrist performed with different speed and calculates components of muscle tone, separating spasticity as reflex phenomenon from resistance due to secondary changes of the muscles and tendons.
Measured: Baseline assesment and 15 min after intervention
Secondary outcomes (1)
Change of manual dexterity after the intervention
Manual dexterity is evaluated using Box and Blocks test. The score is the number of blocks carried by hand from one compartment to the other in one minute.
Measured: Baseline assesment and 15 min after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startSep 2016
- Primary completion15 Sep 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy, SpasticStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Clinic of Rehabilitation, Ukraine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oleh Kachmar, International Clinic of Rehabilitation, Ukraine
- Investigators
- Oleh Kachmar, MD, PhD, Principal investigator, International Clinic of Rehabilitation, Ukraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005938
- Sponsor's protocol ID
- N-09-2016
- Acronym
- SpiManCP
- Status last verified
- Oct 2017
- First submitted
- 21 Dec 2016
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kachmar O, Voloshyn T, Hordiyevych M. Changes in Muscle Spasticity in Patients With Cerebral Palsy After Spinal Manipulation: Case Series. J Chiropr Med. 2016 Dec;15(4):299-304. doi: 10.1016/j.jcm.2016.07.003. Epub 2016 Sep 28.
PubMed 27857638Lindberg PG, Gaverth J, Islam M, Fagergren A, Borg J, Forssberg H. Validation of a new biomechanical model to measure muscle tone in spastic muscles. Neurorehabil Neural Repair. 2011 Sep;25(7):617-25. doi: 10.1177/1545968311403494. Epub 2011 Apr 13.
PubMed 21490269Koziavkin VI, Kachmar OA, Voloshin TB, Gordievich MS. [Components of the muscle tone and quantitative spasticity measurement technique]. The Journal of Neuroscience of B. M. Mankovsky. 2015, vol.3,N1:72-76. in Ukrainian.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Children With Cerebral Palsy, Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT03005938
- Acronym / sponsor ID
- SpiManCP / N-09-2016
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- Cerebral Palsy, Spinal Manipulation, Muscle Spasticity, Manual Dexterity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- International Clinic of Rehabilitation, UkraineUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 30 Dec 2016 (estimated)
- 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.
The aim of the study is to evaluate a short term influence of the Spinal Manipulation (SM) on the wrist muscles spasticity and manual dexterity in children with spastic Cerebral Palsy.
Effect of SM and imitation of the SM has to be compared in the double-blinded randomized clinical trial.
Detailed description
Muscle spasticity is an important clinical syndrome of Cerebral Palsy (CP) resulting from upper motor neuron lesion, and its reduction is a significant therapeutic target for optimizing motor performance.
Investigator's recent study describes decrease in spasticity after SM in a group of children with CP. But that case series has no control group and the sample size was small so it does not prove the influence of the SM on the muscle spasticity.
The purpose of the present study is to evaluate influence of the SM on muscle spasticity and on manual dexterity of the child with CP in a double-blind randomized clinical trial with two arms: SM (experimental group) and imitation of SM (control group).
Children admitted to the International Clinic of Rehabilitation are selected according to inclusion-exclusion criteria and invited to participate. After getting the permission the baseline assessment is performed.
Patients are allocated to the experimental or control group using stratified randomization. Medical doctor certified in Manual Therapy performs the intervention (SM in the experimental group and imitation in the control group) and in 15 minutes the second assessment is performed. Investigators, children and parents are blinded to group allocation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal manipulation | Experimental | Procedure: Spinal manipulationSpinal manipulation |
| Imitation of the spinal manipulation | Sham comparator | Procedure: Imitation of the spinal manipulationImitation of the spinal manipulation |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Spastic uni-, bilateral Cerebral Palsy
- Manual Ability classification level (MACS) - I-III level
- Modified Ashworth scale (MAS) grade 1-3 in wrist or fingers flexors
Key exclusion criteria (6 listed)
- Dyskinetic or ataxic syndrome
- Less than 40 degrees of passive wrist extension with fingers extended
- Botox injections in hand muscles during last year or recent antispastic drugs
- Fracture in hand or forearm less than 6 month prior to examination
- Uncooperative behavior, inability to understand and comply with instructions
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 manipulationAlso: Biomechanical correction of the spineSpinal manipulation (SM) is a therapeutic intervention performed on spinal articulations in which force is applied to the spine. The selected joint is moved to its end range of motion, followed by application of an rapid impulse or thrust to achieve a gapping of the target joint. SM is performed by an orthopedic medical doctor certified in Manual Therapy. After manual evaluation, high-velocity low-amplitude SM is carried out in all regions of the spine, including thoracic adjustments in the prone position, lumbar manipulation in lateral recumbent position, and cervical manipulation in sitting position. | Procedure or surgery | Spinal manipulation |
| Imitation of the spinal manipulationAlso: Sham manipulationImitation of the SM physically and visually resembles the act of SM. It comprises placing the patient in the same positions and performing the same movements as during SM but without applying the force in the end range of motion. | Procedure or surgery | Imitation of the spinal manipulation |
Primary outcome
Change of muscle spasticity after the intervention
Time frame: Baseline assesment and 15 min after intervention
Quantitative, instrumental spasticity measurement is preformed using the Neuroflexor device. It is measuring resistance to passive movements of the wrist performed with different speed and calculates components of muscle tone, separating spasticity as reflex phenomenon from resistance due to secondary changes of the muscles and tendons.
1 secondary outcome
Change of manual dexterity after the intervention
Time frame: Baseline assesment and 15 min after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Background: PubMed 27857638Kachmar O, Voloshyn T, Hordiyevych M. Changes in Muscle Spasticity in Patients With Cerebral Palsy After Spinal Manipulation: Case Series. J Chiropr Med. 2016 Dec;15(4):299-304. doi: 10.1016/j.jcm.2016.07.003. Epub 2016 Sep 28.
- Background: PubMed 21490269Lindberg PG, Gaverth J, Islam M, Fagergren A, Borg J, Forssberg H. Validation of a new biomechanical model to measure muscle tone in spastic muscles. Neurorehabil Neural Repair. 2011 Sep;25(7):617-25. doi: 10.1177/1545968311403494. Epub 2011 Apr 13.
- BackgroundKoziavkin VI, Kachmar OA, Voloshin TB, Gordievich MS. [Components of the muscle tone and quantitative spasticity measurement technique]. The Journal of Neuroscience of B. M. Mankovsky. 2015, vol.3,N1:72-76. in Ukrainian.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Oleh Kachmar, MD, PhD principal investigator
International Clinic of Rehabilitation, Ukraine
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 and Imitation of the spinal manipulation in people with Cerebral Palsy, Spastic, 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 6 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: finished, as of the sponsor's last update on 9 Oct 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of muscle spasticity after the intervention (time frame: Baseline assesment and 15 min after intervention). 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 NCT03005938, which also lists 3 linked publications.
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 9 Oct 2017.