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

International Clinic of Rehabilitation, Ukraine

Status: Completed

Conditions: Cerebral Palsy, Spastic

Treatments: Procedure: Spinal manipulation; Procedure: Imitation of the spinal manipulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03005938

N-09-2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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85 participants in 2 patient groups

Spinal manipulation

Experimental group

Description:

Spinal manipulation

Treatment:

Procedure: Spinal manipulation

Imitation of the spinal manipulation

Sham Comparator group

Description:

Imitation of the spinal manipulation

Treatment:

Procedure: Imitation of the spinal manipulation