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A Pilot Study of Hand Function in Children With Cerebral Palsy Undergoing Intensive Neurophysiological Rehabilitation

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ClinicalTrials.gov Identifier: NCT03454412
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Oleh Kachmar, International Clinic of Rehabilitation, Ukraine

Brief Summary:
The aim of the study is to observe the effects of Intensive Neurophysiological Rehabilitation System on hand function in children with spastic cerebral palsy.

Condition or disease Intervention/treatment
Cerebral Palsy Procedure: Intensive Neurophysiological rehabilitation

Detailed Description:

Intensive Neurophysiological Rehabilitation System is a novel multimodal rehabilitation approach that combines different treatment modalities. The treatment course lasts for 2 weeks with daily therapy up to 4 hours. Main treatment programs include biomechanical correction of the spine, extremity joint mobilization, physical and occupational therapy, reflexotherapy, special massage system, rhythmical group exercises, mechanotherapy and computer games therapy and some other.

Preliminary observational studies indicate an improvement of gross and fine motor functions in children with Cerebral Palsy after the treatment course.

The aim of the study is to observe the effects of Intensive Neurophysiological Rehabilitation System on hand function in children with spastic cerebral palsy.

About 50 patients with spastic forms of cerebral palsy with mild to moderate impairment of hand function (Level I to III according to Manual Abilities Classification System) would be evaluated before and after the two-week treatment course.

This study may help to generate the hypothesis of the effects of the Intensive treatment course on hand function abilities and to prepare a future randomized controlled trial.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study of Hand Function in Children With Cerebral Palsy Undergoing Intensive Neurophysiological Rehabilitation
Actual Study Start Date : March 19, 2018
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Intensive Neurophysiological rehabilitation
    Intensive Neurophysiological rehabilitation system (INRS) is a combination of different treatment modalities that complement and reinforce each other. It includes spinal manipulative therapy, physical therapy, occupational therapy, joints mobilization techniques, special massage therapy, mechanotherapy, computer games therapy and other treatments with daily duration up to 4 hours.


Primary Outcome Measures :
  1. Changes in Jebsen Taylor Hand Functions Test score [ Time Frame: Baseline and after 2 weeks treatment course ]
    The Jebsen Hand Function Test assesses hand function activities during performance of activities of daily living. Test quantifies the time it takes for the subject to do the following standardized functional tasks with one hand: turning over cards, picking up small items, simulating feeding, stacking checkers, picking up light cans, and picking up heavy cans.


Secondary Outcome Measures :
  1. Changes in manual dexterity [ Time Frame: Baseline and after 2 weeks treatment course ]
    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.

  2. Changes in maximum grip force [ Time Frame: Baseline and after 2 weeks treatment course ]
    Maximum grip force is measured by Jamar hand dynamometer

  3. Changes in the ABILHAND-Kids score [ Time Frame: Baseline and after 2 weeks treatment course ]
    ABILHAND-Kids is a measure of manual ability for children with upper limb impairments. The scale measures a person's ability to manage daily activities that require the use of the upper limbs. The Parent is asked to fill in the questionnaire by estimating their child's performance of 21 manual activities on a 3-level scale (impossible, difficult, easy).



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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with spastic cerebral palsy aged six to fifteen undergoing Intensive Neurophysiological Rehabilitation.
Criteria

Inclusion Criteria:

  • Spastic cerebral palsy: uni- and bilateral
  • Age: 6-15
  • Level I-III according to Manual Ability Classification System (MACS)

Exclusion Criteria:

  • Ataxic or dyskinetic cerebral palsy
  • Non-cooperative behavior
  • Moderate to severe mental deficit
  • Severe contractures of upper extremity joints
  • Upper extremities trauma within 6 months prior to the study
  • Previous hand surgery
  • Epilepsy with frequent seizures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454412


Contacts
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Contact: Oleh Kachmar, MD, PhD +380673537927 okachmar@ic.reha.lviv.ua
Contact: Anna Kushnir, MD +380635922667 anna@ic.reha.lviv.ua

Locations
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Ukraine
International Clinic of Rehabilitation Recruiting
Truskavets, Lviv Region, Ukraine, 82200
Contact: Anna D Kushnir, MD    +380635922667    anna@ic.reha.lviv.ua   
Principal Investigator: Oleh O Kachmar, MD, PhD         
Sub-Investigator: Anna D Kushnir, MD         
Sub-Investigator: Oles Matiushenko, MD         
Sub-Investigator: Marko Hasiuk, MD         
Sponsors and Collaborators
International Clinic of Rehabilitation, Ukraine
Investigators
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Principal Investigator: Oleh Kachmar, MD, PhD International Clinic of Rehabilitation, Ukraine

Publications:
Kozyavkin VI, Kachmar OO. Rehabilitation outcome assessment methods in Intensive neurophysiological rehabilitation system. Ukrayinskyj Medychnyj Chasopys. 2003;3(35):61-66. [in Ukrainian]
Kozyavkin VI, Babadagly MO, Lun GP. : . Intensive Neurophysiological Rehabilitation System—the Kozyavkin Method. A Manual for Rehabilitation Specialists, Design studio Papuga; Lviv, Ukraine, 2012

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Responsible Party: Oleh Kachmar, Head of Innovative Technologies Department, International Clinic of Rehabilitation, Ukraine
ClinicalTrials.gov Identifier: NCT03454412     History of Changes
Other Study ID Numbers: N-02-2018
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participants data will be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Oleh Kachmar, International Clinic of Rehabilitation, Ukraine:
Cerebral Palsy
Rehabilitation
Hand

Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases