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

NCT03005938 | Completed DMC

• 1 other identifier: N-09-2016
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy, Spastic

Keywords

Cerebral Palsy; Spinal Manipulation; Muscle Spasticity; Manual Dexterity

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline assesment and 15 min after intervention

Secondary Outcomes (1)

• Change of manual dexterity after the intervention

  Baseline assesment and 15 min after intervention

Study Arms (2)

Spinal manipulation

EXPERIMENTAL

Spinal manipulation

Procedure: Spinal manipulation

Imitation of the spinal manipulation

SHAM COMPARATOR

Imitation of the spinal manipulation

Procedure: Imitation of the spinal manipulation

Interventions

Spinal manipulation PROCEDURE

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.

Also known as: Biomechanical correction of the spine

Spinal manipulation

Imitation of the spinal manipulation PROCEDURE

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.

Also known as: Sham manipulation

Imitation of the spinal manipulation

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Clinic of Rehabilitation, Ukraine: lead

Study Sites (1)

International Clinic of Rehabilitation

Truskavets, Lviv Oblast, 82200, Ukraine

Location

Related Publications (3)

• 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.

  PMID: 27857638 BACKGROUND

• 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.

  PMID: 21490269 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Oleh Kachmar, MD, PhD

  International Clinic of Rehabilitation, Ukraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Innovative Technologies Department

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 30, 2016
• Study Start: September 1, 2016
• Primary Completion: September 15, 2017
• Study Completion: September 15, 2017
• Last Updated: October 9, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)