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

NCT03282422 | Completed

• 1 other identifier: FF_TE_01_Versión 3
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Hemiplegia and Hemiparesis; Cerebral Palsy Infantile

Keywords

Cerebral palsy; Hemiplegia; Upper-limb splint; Home-based; Social Participation

Outcome Measures

Primary Outcomes (2)

• 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 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 Outcomes (5)

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

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

• 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.

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

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

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

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

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

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

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

Study Arms (2)

Intervention group

EXPERIMENTAL

Upper-limb splint and home-based protocol in specific tasks

Device: Home-based protocol in specific tasks; Device: Upper-limb splint

Control group

ACTIVE COMPARATOR

Home-based protocol in specific tasks

Device: Home-based protocol in specific tasks

Interventions

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.

Control group; Intervention group

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.

Intervention group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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 ...).

Sponsors & Collaborators

• Universidad San Jorge: lead
• AIDIMO Asociación para la investigación en la discapacidad motriz: collaborator

Study Sites (2)

AIDIMO Asociación para la investigación en la discapacidad motriz

Zaragoza, 50011, Spain

Location

Universidad San Jorge

Zaragoza, 50830, Spain

Location

Related Publications (33)

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• Roldan-Perez P, Abuin-Porras V, Buesa-Estellez A, Ortiz-Lucas M. Functional Splinting efficacy in a Specific Task Home Program for Children with Cerebral Palsy. A Randomized Controlled Trial. Dev Neurorehabil. 2022 Oct;25(7):469-478. doi: 10.1080/17518423.2022.2099027. Epub 2022 Jul 13.

  PMID: 35822931 DERIVED

MeSH Terms

Conditions

Hemiplegia; Paresis; Cerebral Palsy

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Study Officials

• María Ortiz Lucas, PhD

  Universidad San Jorge

  STUDY DIRECTOR

• Vanesa Abuín Porras, PhD

  Universidad Europea de Madrid

  STUDY DIRECTOR

• Patricia Roldán Pérez, MSc

  Universidad San Jorge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 14, 2017
• Study Start: September 11, 2017
• Primary Completion: February 28, 2019
• Study Completion: March 19, 2019
• Last Updated: July 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)