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

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ClinicalTrials.gov Identifier: NCT03282422
Recruitment Status : Completed
First Posted : September 14, 2017
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
AIDIMO Asociación para la investigación en la discapacidad motriz
Information provided by (Responsible Party):
Universidad San Jorge

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hemiplegia and Hemiparesis Cerebral Palsy Infantile Device: Home-based protocol in specific tasks Device: Upper-limb splint Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of the Functional Hand Splint and Specific Tasks in the Domiciliary Environment Applied to Children With Unilateral Cerebral Palsy. Randomized Clinical Trial
Actual Study Start Date : September 11, 2017
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : March 19, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
Upper-limb splint and home-based protocol in specific tasks
Device: Home-based protocol in specific tasks
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.

Device: Upper-limb splint
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.

Active Comparator: Control group
Home-based protocol in specific tasks
Device: Home-based protocol in specific tasks
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282422


Locations
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Spain
AIDIMO Asociación para la investigación en la discapacidad motriz
Zaragoza, Spain, 50011
Universidad San Jorge
Zaragoza, Spain, 50830
Sponsors and Collaborators
Universidad San Jorge
AIDIMO Asociación para la investigación en la discapacidad motriz
Investigators
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Study Director: María Ortiz Lucas, PhD Universidad San Jorge
Study Director: Vanesa Abuín Porras, PhD Universidad Europea de Madrid
Principal Investigator: Patricia Roldán Pérez, MSc Universidad San Jorge

Publications:
Kolb B, Whishaw IQ. Neuropsicología humana: Ed. Médica Panamericana; 2006.
Mathiowetz V, Federman S, Wiemer D. Box and block test of manual dexterity: norms for 6-19 year olds 52(5):241-5, 1985.

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Responsible Party: Universidad San Jorge
ClinicalTrials.gov Identifier: NCT03282422     History of Changes
Other Study ID Numbers: FF_TE_01_Versión 3
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad San Jorge:
Cerebral palsy
Hemiplegia
Upper-limb splint
Home-based
Social Participation
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Paresis
Hemiplegia
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases