A Pilot Study of Hand Function in Children With Cerebral Palsy Undergoing Intensive Neurophysiological Rehabilitation
NCT ID: NCT03454412
Last Updated: 2021-05-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
44 participants
OBSERVATIONAL
2018-03-19
2019-05-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intensive Neurorehabilitation for Cerebral Palsy
NCT04093180
Efficacy Study of an Interactive Robot for the Rehabilitation of the Upper Limb in Children With Cerebral Palsy
NCT01700153
Implementation of a New Motor Skill Learning Therapeutic Device in Children With Cerebral Palsy Rehabilitation
NCT03930836
Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Cerebral Palsy.
NCT03005938
Intensive Bimanual Intervention in Cerebral Palsy Children
NCT05423171
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age: 6-15
* Level I-III according to Manual Ability Classification System (MACS)
Exclusion Criteria
* 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
6 Years
15 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
International Clinic of Rehabilitation, Ukraine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Oleh Kachmar
Head of Innovative Technologies Department
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Oleh Kachmar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
International Clinic of Rehabilitation, Ukraine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
International Clinic of Rehabilitation
Truskavets, Lviv Oblast, Ukraine
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
N-02-2018
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.