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Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Cerebral Palsy. (SpiManCP)

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ClinicalTrials.gov Identifier: NCT03005938
Recruitment Status : Completed
First Posted : December 30, 2016
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Oleh Kachmar, International Clinic of Rehabilitation, Ukraine

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Cerebral Palsy, Spastic Procedure: Spinal manipulation Procedure: Imitation of the spinal manipulation Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Children With Cerebral Palsy, Randomized Control Trial.
Study Start Date : September 2016
Actual Primary Completion Date : September 15, 2017
Actual Study Completion Date : September 15, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Spinal manipulation
Spinal manipulation
 Procedure: 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.

Other Name: Biomechanical correction of the spine
Sham Comparator: Imitation of the spinal manipulation
Imitation of the spinal manipulation
 Procedure: 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 Name: Sham manipulation


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change of manual dexterity after the intervention [ Time Frame: Baseline assesment and 15 min after 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.


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03005938


Locations
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Ukraine
International Clinic of Rehabilitation
Truskavets, Lviv region, Ukraine, 82200
Sponsors and Collaborators
International Clinic of Rehabilitation, Ukraine
Investigators
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Principal Investigator: Oleh Kachmar, MD, PhD International Clinic of Rehabilitation, Ukraine
More Information
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Publications:
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.

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Responsible Party: Oleh Kachmar, Head of Innovative Technologies Department, International Clinic of Rehabilitation, Ukraine
ClinicalTrials.gov Identifier: NCT03005938    
Other Study ID Numbers: N-09-2016
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Oleh Kachmar, International Clinic of Rehabilitation, Ukraine:
Cerebral Palsy
Spinal Manipulation
Muscle Spasticity
Manual Dexterity
Additional relevant MeSH terms:
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Muscle Spasticity
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
 Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations