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The aim of the study is to observe the effects of Intensive Neurophysiological Rehabilitation System on hand function in children with spastic cerebral palsy.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Neurophysiological Rehabilitation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Jebsen Taylor Hand Function Test for Dominant Hand | 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. | Baseline and post intervention (after the two-week treatment course) |
| Jebsen Taylor Hand Function Test for Non-Dominant Hand | 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. | Baseline and post intervention (after the two-week treatment course) |
| Measure | Description | Time Frame |
|---|---|---|
| ABILHAND-Kids Test Score | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Children with spastic cerebral palsy aged six to fifteen undergoing Intensive Neurophysiological Rehabilitation.
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| Name | Affiliation | Role |
|---|---|---|
| Oleh Kachmar, MD, PhD | International Clinic of Rehabilitation, Ukraine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Clinic of Rehabilitation | Truskavets | Lviv Oblast | 82200 | Ukraine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27857638 | Background | 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. | |
| 23330186 | Background | Koziavkin VI, Voloshin TB, Gordievich MS, Kachmar OA. [Changes of motor function in patients with cerebral palsy during the treatment using the intensive neurophysiological rehabilitation system]. Zh Nevrol Psikhiatr Im S S Korsakova. 2012;112(7 Pt 2):14-7. Russian. |
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No individual participants data will be shared.
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32 of total enrolled 44 participants met inclusion criteria and were included into the study
Patients that met inclusion criteria and scheduled for the treatment to the International Clinic of Rehabilitation were invited.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intensive Neurophysiological Rehabilitation | Patients undergoing 2 weeks treatment course |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Assesment |
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| Treatment Course |
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| Final Assesment |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intensive Neurophysiological Rehabilitation | Patients undergoing two-weeks treatment course of Intensive Neurophysiological Rehabilitation |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Jebsen Taylor Hand Function Test for Dominant Hand | 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. | Posted | Mean | Standard Deviation | seconds | Baseline and post intervention (after the two-week treatment course) |
|
Two weeks - from Baseline assesment till the Post intervention assesment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intensive Neurophysiological Rehabilitation | Patients undergoing two-week treatment course of Intensive Neurophysiological Rehabilitation |
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Short-term period of study, lack of blinding due to the pre-post design with the absence of the control group, and relatively small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oleh Kachmar | International Clinic of Rehabilitation | +380324765200 | okachmar@ic.reha.lviv.ua |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 15, 2017 | Apr 22, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Baseline and post intervention (after the two-week treatment course) |
| Box and Blocks Test for Dominant Hand | 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. | Baseline and post intervention (after the two-week treatment course) |
| Box and Blocks Test for Non-Dominant Hand | 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. | Baseline and post intervention (after the two-week treatment course) |
| Maximum Grip Force of the Dominant Hand | 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 | Baseline and post intervention (after the two-week treatment course) |
| Maximum Grip Force of the Non-Dominant Hand | 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 | Baseline and post intervention (after the two-week treatment course) |
| Background | Kozyavkin VI, Kachmar OO. Rehabilitation outcome assessment methods in Intensive neurophysiological rehabilitation system. Ukrayinskyj Medychnyj Chasopys. 2003;3(35):61-66. [in Ukrainian] |
| Background | Kozyavkin VI, Babadagly MO, Lun GP. : . Intensive Neurophysiological Rehabilitation System-the Kozyavkin Method. A Manual for Rehabilitation Specialists, Design studio Papuga; Lviv, Ukraine, 2012 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Dominant hand | Count of Participants | Participants |
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| Diagnosis | Count of Participants | Participants |
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| Manual Ability Classification System level | The Manual Ability Classification System (MACS) describes how children with cerebral palsy use their hands to handle objects in daily activities. MACS includes five levels. Level I - Handles objects easily and successfully. Level II. Handles most objects but with somewhat reduced quality /speed. Level III - Handles objects with difficulty; needs help to prepare and/or modify activities. Level IV. Handles a limited selection of easily managed objects in adapted situations. Level V. Does not handle objects and has severely limited ability to perform even simple actions. | Count of Participants | Participants |
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| GMFCS level | The Gross Motor Function Classification System or GMFCS is a 5 level clinical classification system that describes the gross motor function of people with cerebral palsy on the basis of self-initiated movement abilities Level I - Walks without Limitations Level II - Walks with Limitations Level III - Walks Using a Hand-Held Mobility Device Level IV - Self-Mobility with Limitations; May Use Powered Mobility Level V - Transported in a Manual Wheelchair | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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|
| Primary | Jebsen Taylor Hand Function Test for Non-Dominant Hand | 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. | Posted | Mean | Standard Deviation | seconds | Baseline and post intervention (after the two-week treatment course) |
|
|
|
| Secondary | ABILHAND-Kids Test Score | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and post intervention (after the two-week treatment course) |
|
|
|
| Secondary | Box and Blocks Test for Dominant Hand | 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. | Posted | Mean | Standard Deviation | blocks carried | Baseline and post intervention (after the two-week treatment course) |
|
|
|
| Secondary | Box and Blocks Test for Non-Dominant Hand | 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. | Posted | Mean | Standard Deviation | blocks carried | Baseline and post intervention (after the two-week treatment course) |
|
|
|
| Secondary | Maximum Grip Force of the Dominant Hand | 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 | Posted | Mean | Standard Deviation | kilogram | Baseline and post intervention (after the two-week treatment course) |
|
|
|
| Secondary | Maximum Grip Force of the Non-Dominant Hand | 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 | Posted | Mean | Standard Deviation | kilogram | Baseline and post intervention (after the two-week treatment course) |
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| 0 |
| 32 |
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| 32 |
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| 32 |
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