Clinical trial NCT03454412: A Pilot Study of Hand Function in Children With Cerebral Palsy Undergoing Intensive Neurophysiological Rehabilitation
Official title: A Pilot Study of Hand Function in Children With Cerebral Palsy Undergoing Intensive Neurophysiological Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Rehabilitation
Hand
Lead sponsor: International Clinic of Rehabilitation, Ukraine
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 44
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with spastic cerebral palsy aged six to fifteen undergoing Intensive Neurophysiological Rehabilitation.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Jebsen Taylor Hand Function Test for Dominant Hand
timeFrame: Baseline and post intervention (after the two-week treatment course)
measure: Jebsen Taylor Hand Function Test for Non-Dominant Hand
timeFrame: Baseline and post intervention (after the two-week treatment course)
Secondary outcomes:
measure: ABILHAND-Kids Test Score
timeFrame: Baseline and post intervention (after the two-week treatment course)
measure: Box and Blocks Test for Dominant Hand
timeFrame: Baseline and post intervention (after the two-week treatment course)
measure: Box and Blocks Test for Non-Dominant Hand
timeFrame: Baseline and post intervention (after the two-week treatment course)
measure: Maximum Grip Force of the Dominant Hand
timeFrame: Baseline and post intervention (after the two-week treatment course)
measure: Maximum Grip Force of the Non-Dominant Hand
timeFrame: Baseline and post intervention (after the two-week treatment course)
Other outcomes:
Locations:
city: Truskavets
country: Ukraine
facility: International Clinic of Rehabilitation
state: Lviv Region
Study officials:
affiliation: International Clinic of Rehabilitation, Ukraine
name: Oleh Kachmar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: Kozyavkin VI, Kachmar OO. Rehabilitation outcome assessment methods in Intensive neurophysiological rehabilitation system. Ukrayinskyj Medychnyj Chasopys. 2003;3(35):61-66. [in Ukrainian]
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