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Clinical Trials/NCT03454412
NCT03454412
Completed
Not Applicable

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

International Clinic of Rehabilitation, Ukraine1 site in 1 country44 target enrollmentMarch 19, 2018
ConditionsCerebral Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
International Clinic of Rehabilitation, Ukraine
Enrollment
44
Locations
1
Primary Endpoint
Jebsen Taylor Hand Function Test for Dominant Hand
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 19, 2018
End Date
May 1, 2019
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
International Clinic of Rehabilitation, Ukraine
Responsible Party
Principal Investigator
Principal Investigator

Oleh Kachmar

Head of Innovative Technologies Department

International Clinic of Rehabilitation, Ukraine

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

Outcomes

Primary Outcomes

Jebsen Taylor Hand Function Test for Dominant Hand

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

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.

Jebsen Taylor Hand Function Test for Non-Dominant Hand

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

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.

Secondary Outcomes

  • Box and Blocks Test for Non-Dominant Hand(Baseline and post intervention (after the two-week treatment course))
  • 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))
  • 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))

Study Sites (1)

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