Clinical trial NCT03005938: Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Cerebral Palsy.
Official title: Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Children With Cerebral Palsy, Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy, Spastic
Keywords: Cerebral Palsy
Spinal Manipulation
Muscle Spasticity
Manual Dexterity
Lead sponsor: International Clinic of Rehabilitation, Ukraine
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 85
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change of muscle spasticity after the intervention
timeFrame: Baseline assesment and 15 min after intervention
Secondary outcomes:
measure: Change of manual dexterity after the intervention
timeFrame: Baseline assesment and 15 min after intervention
Other outcomes:
Locations:
city: Truskavets
country: Ukraine
facility: International Clinic of Rehabilitation
state: Lviv region
Study officials:
affiliation: International Clinic of Rehabilitation, Ukraine
name: Oleh Kachmar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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.