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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Procedure: Intensive Neurophysiological Rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ABILHAND-Kids Test Score | Ability of the hand (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). Measured score is expressed in logits ranging from - 7 to +7. The logit is a linear unit that expresses the odds of success of the patient on any given item. The higher score indicates better function. | Baseline and post intervention (after the two-week treatment course) | 
| Box and Blocks Test for Dominant Hand | The test is measuring the dexterity of the dominant hand. The score is the number of blocks carried by the dominant hand from one compartment to the other in one minute. | Baseline and post intervention (after the two-week treatment course) | 
| Box and Blocks Test for Non-Dominant Hand | The test is measuring the dexterity of the non-dominant hand. The score is the number of blocks carried by the non-dominant hand from one compartment to the other in one minute. | Baseline and post intervention (after the two-week treatment course) | 
| Maximum Grip Force of the Dominant Hand | Grip force of the Dominant Hand is measured by Jamar hand dynamometer in kilograms. All children had three trials and the best result was recorded | Baseline and post intervention (after the two-week treatment course) | 
| Maximum Grip Force of the Non-Dominant Hand | Grip force of the Non0Dominant Hand is measured by Jamar hand dynamometer in kilograms. All children had three trials and the best result was recorded | Baseline and post intervention (after the two-week treatment course) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Palsy, Rehabilitation, Hand