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

NCT03454412 | Completed Results

• 1 other identifier: N-02-2018
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Rehabilitation; Hand

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (5)

• ABILHAND-Kids Test Score

  Baseline and post intervention (after the two-week treatment course)

• Box and Blocks Test for Dominant Hand

  Baseline and post intervention (after the two-week treatment course)

• Box and Blocks Test for Non-Dominant Hand

  Baseline and post intervention (after the two-week treatment course)

• Maximum Grip Force of the Dominant Hand

  Baseline and post intervention (after the two-week treatment course)

• Maximum Grip Force of the Non-Dominant Hand

  Baseline and post intervention (after the two-week treatment course)

Interventions

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.

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with spastic cerebral palsy aged six to fifteen undergoing Intensive Neurophysiological Rehabilitation.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Clinic of Rehabilitation, Ukraine: lead

Study Sites (1)

International Clinic of Rehabilitation

Truskavets, Lviv Oblast, 82200, Ukraine

Location

Related 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. doi: 10.1016/j.jcm.2016.07.003. Epub 2016 Sep 28.

  PMID: 27857638 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.

  PMID: 23330186 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

  BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Oleh Kachmar
• Organization: International Clinic of Rehabilitation

okachmar@ic.reha.lviv.ua

+380324765200

Study Officials

• Oleh Kachmar, MD, PhD

  International Clinic of Rehabilitation, Ukraine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Innovative Technologies Department

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 5, 2018
• Study Start: March 19, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 25, 2021
• Results First Posted: May 25, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)