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NCT Number: NCT03454412

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

The aim of the study is to observe the effects of Intensive Neurophysiological Rehabilitation System on hand function in children with spastic cerebral palsy.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

International Clinic of Rehabilitation

Truskavets, Lviv Oblast, 82200, Ukraine

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive Neurophysiological Rehabilitation

Procedure

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.

Primary outcomes

  1. 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.

  2. 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

  1. ABILHAND-Kids Test Score

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

    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.

  2. Box and Blocks Test for Dominant Hand

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

    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.

  3. Box and Blocks Test for Non-Dominant Hand

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

    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.

  4. Maximum Grip Force of the Dominant Hand

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

    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

  5. Maximum Grip Force of the Non-Dominant Hand

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

    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

Sponsors and collaborators

Lead sponsor

International Clinic of Rehabilitation, Ukraine

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2018
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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