A Pilot Study of Hand Function in Children With Cerebral Palsy Undergoing Intensive Neurophysiological Rehabilitation
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|ClinicalTrials.gov Identifier: NCT03454412|
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : August 8, 2018
|Condition or disease||Intervention/treatment|
|Cerebral Palsy||Procedure: Intensive Neurophysiological rehabilitation|
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 Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||A Pilot Study of Hand Function in Children With Cerebral Palsy Undergoing Intensive Neurophysiological Rehabilitation|
|Actual Study Start Date :||March 19, 2018|
|Estimated Primary Completion Date :||September 1, 2018|
|Estimated Study Completion Date :||November 1, 2018|
- 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.
- Changes in Jebsen Taylor Hand Functions Test score [ Time Frame: Baseline and after 2 weeks treatment course ]The Jebsen Hand Function Test assesses hand function activities during performance of activities of daily living. 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.
- Changes in manual dexterity [ Time Frame: Baseline and after 2 weeks treatment course ]Manual dexterity is evaluated using Box and Blocks test. The score is the number of blocks carried by hand from one compartment to the other in one minute.
- Changes in maximum grip force [ Time Frame: Baseline and after 2 weeks treatment course ]Maximum grip force is measured by Jamar hand dynamometer
- Changes in the ABILHAND-Kids score [ Time Frame: Baseline and after 2 weeks treatment course ]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).
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
|Contact: Oleh Kachmar, MD, PhDfirstname.lastname@example.org|
|Contact: Anna Kushnir, MDemail@example.com|
|International Clinic of Rehabilitation||Recruiting|
|Truskavets, Lviv Region, Ukraine, 82200|
|Contact: Anna D Kushnir, MD +380635922667 firstname.lastname@example.org|
|Principal Investigator: Oleh O Kachmar, MD, PhD|
|Sub-Investigator: Anna D Kushnir, MD|
|Sub-Investigator: Oles Matiushenko, MD|
|Sub-Investigator: Marko Hasiuk, MD|
|Principal Investigator:||Oleh Kachmar, MD, PhD||International Clinic of Rehabilitation, Ukraine|