Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Cerebral Palsy. (SpiManCP)
Primary Purpose
Cerebral Palsy, Spastic
Status
Completed
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
Spinal manipulation
Imitation of the spinal manipulation
Sponsored by
About this trial
This is an interventional basic science trial for Cerebral Palsy, Spastic focused on measuring Cerebral Palsy, Spinal Manipulation, Muscle Spasticity, Manual Dexterity
Eligibility 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
Sites / Locations
- International Clinic of Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Spinal manipulation
Imitation of the spinal manipulation
Arm Description
Spinal manipulation
Imitation of the spinal manipulation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03005938
First Posted
December 21, 2016
Last Updated
October 6, 2017
Sponsor
International Clinic of Rehabilitation, Ukraine
1. Study Identification
Unique Protocol Identification Number
NCT03005938
Brief Title
Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Cerebral Palsy.
Acronym
SpiManCP
Official Title
Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Children With Cerebral Palsy, Randomized Control Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 15, 2017 (Actual)
Study Completion Date
September 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Clinic of Rehabilitation, Ukraine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic
Keywords
Cerebral Palsy, Spinal Manipulation, Muscle Spasticity, Manual Dexterity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spinal manipulation
Arm Type
Experimental
Arm Description
Spinal manipulation
Arm Title
Imitation of the spinal manipulation
Arm Type
Sham Comparator
Arm Description
Imitation of the spinal manipulation
Intervention Type
Procedure
Intervention Name(s)
Spinal manipulation
Other Intervention Name(s)
Biomechanical correction of the spine
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Imitation of the spinal manipulation
Other Intervention Name(s)
Sham manipulation
Intervention 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.
Primary Outcome Measure Information:
Title
Change of muscle spasticity after the 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.
Time Frame
Baseline assesment and 15 min after intervention
Secondary Outcome Measure Information:
Title
Change of manual dexterity after the 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.
Time Frame
Baseline assesment and 15 min after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oleh Kachmar, MD, PhD
Organizational Affiliation
International Clinic of Rehabilitation, Ukraine
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Clinic of Rehabilitation
City
Truskavets
State/Province
Lviv region
ZIP/Postal Code
82200
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27857638
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.
Results Reference
background
PubMed Identifier
21490269
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.
Results Reference
background
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.
Results Reference
background
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Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Cerebral Palsy.
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