Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Cerebral Palsy.
NCT ID: NCT03005938
Last Updated: 2017-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
85 participants
INTERVENTIONAL
2016-09-30
2017-09-15
Brief Summary
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Effect of SM and imitation of the SM has to be compared in the double-blinded randomized clinical trial.
Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Spinal manipulation
Spinal manipulation
Spinal manipulation
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 manipulation
Imitation of the spinal manipulation
Imitation of the spinal 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.
Interventions
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Spinal manipulation
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 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Manual Ability classification level (MACS) - I-III level
* Modified Ashworth scale (MAS) grade 1-3 in wrist or fingers flexors
Exclusion Criteria
* 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
8 Years
18 Years
ALL
No
Sponsors
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International Clinic of Rehabilitation, Ukraine
OTHER
Responsible Party
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Oleh Kachmar
Head of Innovative Technologies Department
Principal Investigators
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Oleh Kachmar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
International Clinic of Rehabilitation, Ukraine
Locations
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International Clinic of Rehabilitation
Truskavets, Lviv Oblast, Ukraine
Countries
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References
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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.
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.
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.
Other Identifiers
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N-09-2016
Identifier Type: -
Identifier Source: org_study_id