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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

Tracking Information
First Submitted Date  ICMJE December 21, 2016
First Posted Date  ICMJE December 30, 2016
Last Update Posted Date October 9, 2017
Study Start Date  ICMJE September 2016
Actual Primary Completion Date September 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2016)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Cerebral Palsy.
Official Title  ICMJE Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Children With Cerebral Palsy, Randomized Control Trial.
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Cerebral Palsy, Spastic
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Spinal manipulation
    Spinal manipulation
    Intervention: Procedure: Spinal manipulation
  • Sham Comparator: Imitation of the spinal manipulation
    Imitation of the spinal manipulation
    Intervention: Procedure: Imitation of the spinal manipulation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2017)
85
Original Estimated Enrollment  ICMJE
 (submitted: December 26, 2016)
100
Actual Study Completion Date  ICMJE September 15, 2017
Actual Primary Completion Date September 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03005938
Other Study ID Numbers  ICMJE N-09-2016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Oleh Kachmar, International Clinic of Rehabilitation, Ukraine
Study Sponsor  ICMJE International Clinic of Rehabilitation, Ukraine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Oleh Kachmar, MD, PhD International Clinic of Rehabilitation, Ukraine
PRS Account International Clinic of Rehabilitation, Ukraine
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP