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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03454412
Recruitment Status : Completed
First Posted : March 5, 2018
Results First Posted : May 25, 2021
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Oleh Kachmar, International Clinic of Rehabilitation, Ukraine

Study Description
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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.

Study Design
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Study Type : Observational
Actual Enrollment : 44 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
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.

Outcome Measures
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Primary Outcome Measures :
  1. Jebsen Taylor Hand Function Test for Dominant Hand [ Time Frame: Baseline and post intervention (after the two-week treatment course) ]

    The Jebsen Hand Function Test for Dominant Hand assesses hand function activities during performance of activities of daily living of the dominant hand.

    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.Total score is the sum of time taken for each sub-test, which are rounded to the nearest second. Shorter times indicate better performance.


  2. Jebsen Taylor Hand Function Test for Non-Dominant Hand [ Time Frame: Baseline and post intervention (after the two-week treatment course) ]

    The Jebsen Hand Function Test for Non-Dominant Hand assesses hand function activities during performance of activities of daily living of the non-dominant hand.

    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.Total score is the sum of time taken for each sub-test, which are rounded to the nearest second. Shorter times indicate better performance.



Secondary Outcome Measures :
  1. ABILHAND-Kids Test Score [ Time Frame: Baseline and post intervention (after the two-week treatment course) ]

    Ability of the hand (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).

    Measured score is expressed in logits ranging from "- 7" to "+7". The logit is a linear unit that expresses the odds of success of the patient on any given item. The higher score indicates better function.


  2. Box and Blocks Test for Dominant Hand [ Time Frame: Baseline and post intervention (after the two-week treatment course) ]
    The test is measuring the dexterity of the dominant hand. The score is the number of blocks carried by the dominant hand from one compartment to the other in one minute.

  3. Box and Blocks Test for Non-Dominant Hand [ Time Frame: Baseline and post intervention (after the two-week treatment course) ]
    The test is measuring the dexterity of the non-dominant hand. The score is the number of blocks carried by the non-dominant hand from one compartment to the other in one minute.

  4. Maximum Grip Force of the Dominant Hand [ Time Frame: Baseline and post intervention (after the two-week treatment course) ]
    Grip force of the Dominant Hand is measured by Jamar hand dynamometer in kilograms. All children had three trials and the best result was recorded

  5. Maximum Grip Force of the Non-Dominant Hand [ Time Frame: Baseline and post intervention (after the two-week treatment course) ]
    Grip force of the Non0Dominant Hand is measured by Jamar hand dynamometer in kilograms. All children had three trials and the best result was recorded


Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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Ukraine
International Clinic of Rehabilitation
Truskavets, Lviv Region, Ukraine, 82200
Sponsors and Collaborators
International Clinic of Rehabilitation, Ukraine
Investigators
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Principal Investigator: Oleh Kachmar, MD, PhD International Clinic of Rehabilitation, Ukraine
  Study Documents (Full-Text)

Documents provided by Oleh Kachmar, International Clinic of Rehabilitation, Ukraine:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] May 15, 2017

More Information
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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    
Other Study ID Numbers: N-02-2018
First Posted: March 5, 2018    Key Record Dates
Results First Posted: May 25, 2021
Last Update Posted: May 25, 2021
Last Verified: April 2021
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
 Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases