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Completed

NCT Number: NCT03282422

Effectiveness of the Functional Hand Splint and Specific Tasks in the Domiciliary Environment Applied to Children With Unilateral Cerebral Palsy

The main objective:

To determine the effectiveness of a treatment that combines the application of a functional upper limb orthosis together with a home-based program of specific tasks in children with unilateral cerebral palsy versus a home-based program of specific tasks in improving structure and function, activity and participation.

Hypothesis:

The application of a functional upper limb orthosis together with a home-based program of specific tasks in children with unilateral cerebral palsy results in a greater improvement in structure and function, activity and participation compared to the implementation of a home-based specific task program.

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Key information

Conditions

Hemiplegia and Hemiparesis Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Cerebral Palsy Infantile Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AIDIMO Asociación para la investigación en la discapacidad motriz, Zaragoza, Spain

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About this study

Randomized clinical trial with blinding of the evaluator and the person analyzing the data.

A home-based protocol of specific tasks will be performed in both groups and one of the groups will also receive a treatment with upper limb splinting. The assessment will be made by a single evaluator with 10 years of experience in the treatment of children with motor disabilities.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of unilateral cerebral palsy (hemiplegia-hemiparesis).
  • Ages between 5 and 12 years.
  • Levels I-III of the Manual Ability Classification System (MACS)
  • Levels I-III of the Gross Motor Function Classification System (GMFCS)
  • Able to understand and respond to verbal instructions.

Exclusion criteria

  • Cognitive impairment identified by the school report.
  • Hand orthopedic surgery in the last 6 months.
  • Neuropharmacological intervention in the last 6 months.
  • Allergy to upper limb orthosis material.
  • Affectation of the manual function not due to the neurological condition (trauma, burn ...).
  • Current treatments not compatible with the study.
  • Other significant neurological affections (crisis, severe visual impairment ...).

Treatment and study plan

Home-based protocol in specific tasks

Device

The home-based protocol in specific tasks will be an individualized protocol designed for the child according to the results of the baseline assessment and will require active participation. It is a program that is integrated into the daily routines of the child. A study investigator will tell the family the procedure to follow.

Upper-limb splint

Device

In the case that treatment with splint is also received, a researcher of this study will take measurements of the hand and will provide the appropriate splint. The intensity of the application will be 5 days a week from monday to friday, for 6 hours a day, for a period of 6 weeks.

Primary outcomes

  1. Primary Outcome_Change from baseline Assisting Hand Assessment measure. Measurement of bimanual performance in pre-established tasks

    Time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).

    Activity measurement: Assisting Hand Assessment. Measurement of bimanual performance in pre-established tasks. It quantifies the effectiveness with which the child uses his affected hand in bimanual activities.

  2. Primary Outcome_2. Change from baseline Children's Hand-use Experience Questionnaire measure. Measurement of bimanual performance in activities of daily living.

    Time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).

    Participation and activity measurement: Children's Hand-use Experience Questionnaire. The objective of the questionnaire is to measure bimanual performance in activities of daily living.

Secondary outcomes

  1. Secondary Outcome_Change from baseline Box and Blocks Test measure. Measurement of unilateral gross manual dexterity.

    Time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).

    Activity measurement: Box and Blocks Test assesses unilateral gross manual dexterity.

  2. Secondary Outcome_2. Change from baseline Jebsen Hand Function Test measure. Measurement of a broad range of uni-manual hand functions required for activities of daily living.

    Time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).

    Participation measurement: Jebsen Hand Function Test. The objective of this test is to assess a broad range of uni-manual hand functions required for activities of daily living.7 activities performed with the affected hand and healthy hand separately.

  3. Secondary Outcome_3. Change from baseline House Thumb in Palm Deformity Classification. Classify the deformity level of thumb.

    Time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).

    Structure and function measurement: House Thumb in Palm Deformity Classification. This tool classify the deformity levels taking into account the structure of the thumb.

  4. Secondary Outcome_4. Change from baseline Neurological Hand Deformity Classification. This tool classify the deformity levels of wrist and fingers.

    Time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).

    Structure and function measurement: Neurological Hand Deformity Classification. This tools classify the deformity levels taking into account the wrist, fingers.

  5. Secondary Outcome_5. Change from baseline Grip and Pinch Strength measure. Measurement of pinch, wrist and foream strength.

    Time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).

    Structure and function measurement: Grip and Pinch Strength. One will be used to Assess the grip of the thumb (Pinch Gauge Dynamometer) and another to assess the strength of the wrist and forearm (Hand and Wrist Dynamometer).

Sponsors and collaborators

Lead sponsor

Universidad San Jorge

Other

Collaborators

  • AIDIMO Asociación para la investigación en la discapacidad motriz

Registry information

Official study title

Effectiveness of the Functional Hand Splint and Specific Tasks in the Domiciliary Environment Applied to Children With Unilateral Cerebral Palsy. Randomized Clinical Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 14, 2017
Registry last updated
Jul 17, 2019

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

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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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