<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03005938</url>
  </required_header>
  <id_info>
    <org_study_id>N-09-2016</org_study_id>
    <nct_id>NCT03005938</nct_id>
  </id_info>
  <brief_title>Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Cerebral Palsy.</brief_title>
  <acronym>SpiManCP</acronym>
  <official_title>Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Children With Cerebral Palsy, Randomized Control Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Clinic of Rehabilitation, Ukraine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>International Clinic of Rehabilitation, Ukraine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate a short term influence of the Spinal Manipulation (SM) on&#xD;
      the wrist muscles spasticity and manual dexterity in children with spastic Cerebral Palsy.&#xD;
&#xD;
      Effect of SM and imitation of the SM has to be compared in the double-blinded randomized&#xD;
      clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Muscle spasticity is an important clinical syndrome of Cerebral Palsy (CP) resulting from&#xD;
      upper motor neuron lesion, and its reduction is a significant therapeutic target for&#xD;
      optimizing motor performance.&#xD;
&#xD;
      Investigator's recent study describes decrease in spasticity after SM in a group of children&#xD;
      with CP. But that case series has no control group and the sample size was small so it does&#xD;
      not prove the influence of the SM on the muscle spasticity.&#xD;
&#xD;
      The purpose of the present study is to evaluate influence of the SM on muscle spasticity and&#xD;
      on manual dexterity of the child with CP in a double-blind randomized clinical trial with two&#xD;
      arms: SM (experimental group) and imitation of SM (control group).&#xD;
&#xD;
      Children admitted to the International Clinic of Rehabilitation are selected according to&#xD;
      inclusion-exclusion criteria and invited to participate. After getting the permission the&#xD;
      baseline assessment is performed.&#xD;
&#xD;
      Patients are allocated to the experimental or control group using stratified randomization.&#xD;
      Medical doctor certified in Manual Therapy performs the intervention (SM in the experimental&#xD;
      group and imitation in the control group) and in 15 minutes the second assessment is&#xD;
      performed. Investigators, children and parents are blinded to group allocation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">September 15, 2017</completion_date>
  <primary_completion_date type="Actual">September 15, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of muscle spasticity after the intervention</measure>
    <time_frame>Baseline assesment and 15 min after intervention</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of manual dexterity after the intervention</measure>
    <time_frame>Baseline assesment and 15 min after intervention</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Cerebral Palsy, Spastic</condition>
  <arm_group>
    <arm_group_label>Spinal manipulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spinal manipulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Imitation of the spinal manipulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Imitation of the spinal manipulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Spinal manipulation</intervention_name>
    <description>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.&#xD;
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.</description>
    <arm_group_label>Spinal manipulation</arm_group_label>
    <other_name>Biomechanical correction of the spine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Imitation of the spinal manipulation</intervention_name>
    <description>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.</description>
    <arm_group_label>Imitation of the spinal manipulation</arm_group_label>
    <other_name>Sham manipulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Spastic uni-, bilateral Cerebral Palsy&#xD;
&#xD;
          -  Manual Ability classification level (MACS) - I-III level&#xD;
&#xD;
          -  Modified Ashworth scale (MAS) grade 1-3 in wrist or fingers flexors&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dyskinetic or ataxic syndrome&#xD;
&#xD;
          -  Less than 40 degrees of passive wrist extension with fingers extended&#xD;
&#xD;
          -  Botox injections in hand muscles during last year or recent antispastic drugs&#xD;
&#xD;
          -  Fracture in hand or forearm less than 6 month prior to examination&#xD;
&#xD;
          -  Uncooperative behavior, inability to understand and comply with instructions&#xD;
&#xD;
          -  Severe pain preventing the child from being able to complete examinations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Oleh Kachmar, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Clinic of Rehabilitation, Ukraine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>International Clinic of Rehabilitation</name>
      <address>
        <city>Truskavets</city>
        <state>Lviv region</state>
        <zip>82200</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ukraine</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>27857638</PMID>
  </reference>
  <reference>
    <citation>Lindberg 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.</citation>
    <PMID>21490269</PMID>
  </reference>
  <reference>
    <citation>Koziavkin 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.</citation>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>October 6, 2017</last_update_submitted>
  <last_update_submitted_qc>October 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>International Clinic of Rehabilitation, Ukraine</investigator_affiliation>
    <investigator_full_name>Oleh Kachmar</investigator_full_name>
    <investigator_title>Head of Innovative Technologies Department</investigator_title>
  </responsible_party>
  <keyword>Cerebral Palsy</keyword>
  <keyword>Spinal Manipulation</keyword>
  <keyword>Muscle Spasticity</keyword>
  <keyword>Manual Dexterity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03005938
org study id: N-09-2016
nct id: NCT03005938
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Investigator)
measure: Change of muscle spasticity after the intervention
time frame: Baseline assesment and 15 min after intervention
description: 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.
measure: Change of manual dexterity after the intervention
time frame: Baseline assesment and 15 min after intervention
description: 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.
arm group label: Spinal manipulation
arm group type: Experimental
description: Spinal manipulation
arm group label: Imitation of the spinal manipulation
arm group type: Sham Comparator
description: Imitation of the spinal manipulation
intervention type: Procedure
intervention name: Spinal manipulation
description: 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.
arm group label: Spinal manipulation
other name: Biomechanical correction of the spine
intervention type: Procedure
intervention name: Imitation of the spinal manipulation
description: 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.
arm group label: Imitation of the spinal manipulation
other name: Sham manipulation
criteria: 
gender: All
minimum age: 8 Years
maximum age: 18 Years
healthy volunteers: No
last name: Oleh Kachmar, MD, PhD
role: Principal Investigator
affiliation: International Clinic of Rehabilitation, Ukraine
facility: 
country: Ukraine
citation: 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.
PMID: 27857638
citation: Lindberg 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.
PMID: 21490269
citation: Koziavkin 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.
responsible party type: Principal Investigator
investigator affiliation: International Clinic of Rehabilitation, Ukraine
investigator full name: Oleh Kachmar
investigator title: Head of Innovative Technologies Department
mesh term: Muscle Spasticity
mesh term: Paralysis
mesh term: Cerebral Palsy
sharing ipd: No