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NCT Number: NCT03005938

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

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.

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Key information

Conditions

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

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Clinic of Rehabilitation

Truskavets, Lviv Oblast, 82200, Ukraine

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Biomechanical correction of the spine

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.

Other names: Sham manipulation

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

International Clinic of Rehabilitation, Ukraine

Other

Registry information

Official study title

Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Children With Cerebral Palsy, Randomized Control Trial.

Acronym: SpiManCP

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 30, 2016
Registry last updated
Oct 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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