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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03454412
• Other study ID #: N-02-2018
• Status: Completed
• Start date: March 19, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: April 2021
• Source: International Clinic of Rehabilitation, Ukraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

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.

Locations

Country	Name	City	State
Ukraine	International Clinic of Rehabilitation	Truskavets	Lviv Region

Sponsors (1)

Lead Sponsor	Collaborator
International Clinic of Rehabilitation, Ukraine

Country where clinical trial is conducted

Ukraine, 

References & Publications (4)

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. Epub 2016 Sep 28. — View Citation

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. — View Citation

Kozyavkin VI, Babadagly MO, Lun GP. : . Intensive Neurophysiological Rehabilitation System-the Kozyavkin Method. A Manual for Rehabilitation Specialists, Design studio Papuga; Lviv, Ukraine, 2012

Kozyavkin VI, Kachmar OO. Rehabilitation outcome assessment methods in Intensive neurophysiological rehabilitation system. Ukrayinskyj Medychnyj Chasopys. 2003;3(35):61-66. [in Ukrainian]

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and post intervention (after the two-week treatment course)
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.	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.	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.	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.	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	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	Baseline and post intervention (after the two-week treatment course)