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

Cerebral Palsy Infantile Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03282422
• Other study ID #: FF_TE_01_Versión 3
• Status: Completed
• Phase: N/A
• Start date: September 11, 2017
• Est. completion date: March 19, 2019

Study information

• Verified date: April 2019
• Source: Universidad San Jorge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 19, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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 ...).

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy Infantile
• Hemiplegia
• Hemiplegia and Hemiparesis
• Paralysis
• Paresis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	AIDIMO Asociación para la investigación en la discapacidad motriz	Zaragoza
Spain	Universidad San Jorge	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Universidad San Jorge	AIDIMO Asociación para la investigación en la discapacidad motriz

Country where clinical trial is conducted

Spain, 

References & Publications (32)

Amer A, Eliasson AC, Peny-Dahlstrand M, Hermansson L. Validity and test-retest reliability of Children's Hand-use Experience Questionnaire in children with unilateral cerebral palsy. Dev Med Child Neurol. 2016 Jul;58(7):743-9. doi: 10.1111/dmcn.12991. Epub 2015 Nov 26. — View Citation

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Burtner PA, Poole JL, Torres T, Medora AM, Abeyta R, Keene J, Qualls C. Effect of wrist hand splints on grip, pinch, manual dexterity, and muscle activation in children with spastic hemiplegia: a preliminary study. J Hand Ther. 2008 Jan-Mar;21(1):36-42; quiz 43. doi: 10.1197/j.jht.2007.08.018. — View Citation

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Öhrvall AM, Krumlinde-Sundholm L, Eliasson AC. The stability of the Manual Ability Classification System over time. Dev Med Child Neurol. 2014 Feb;56(2):185-9. doi: 10.1111/dmcn.12348. Epub 2013 Nov 25. — View Citation

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome_Change from baseline Assisting Hand Assessment measure. Measurement of bimanual performance in pre-established tasks	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.	Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Primary	Primary Outcome_2. Change from baseline Children's Hand-use Experience Questionnaire measure. Measurement of bimanual performance in activities of daily living.	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.	Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary	Secondary Outcome_Change from baseline Box and Blocks Test measure. Measurement of unilateral gross manual dexterity.	Activity measurement: Box and Blocks Test assesses unilateral gross manual dexterity.	Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary	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.	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.	Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary	Secondary Outcome_3. Change from baseline House Thumb in Palm Deformity Classification. Classify the deformity level of thumb.	Structure and function measurement: House Thumb in Palm Deformity Classification. This tool classify the deformity levels taking into account the structure of the thumb.	Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary	Secondary Outcome_4. Change from baseline Neurological Hand Deformity Classification. This tool classify the deformity levels of wrist and fingers.	Structure and function measurement: Neurological Hand Deformity Classification. This tools classify the deformity levels taking into account the wrist, fingers.	Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary	Secondary Outcome_5. Change from baseline Grip and Pinch Strength measure. Measurement of pinch, wrist and foream strength.	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).	Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).