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

Not Applicable

Completed

• Conditions: Hemiplegia and Hemiparesis; Cerebral Palsy Infantile
• Interventions: Device: Home-based protocol in specific tasks; Device: Upper-limb splint

• Registration Number: NCT03282422
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2017-09-06
• Study Start: 2017-09-11
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-14
• Primary Completion: 2019-02-28
• Study Completion: 2019-03-19
• Status Verified: 2019-04
• Last Update Submitted: 2019-07-16
• Last Update Posted: 2019-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 ...).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Home-based protocol in specific tasks	Upper-limb splint and home-based protocol in specific tasks
Control group	Home-based protocol in specific tasks	Home-based protocol in specific tasks
Intervention group	Upper-limb splint	Upper-limb splint and home-based protocol in specific tasks

Primary Outcome Measures

Name	Time	Method
Primary Outcome_Change from baseline Assisting Hand Assessment measure. Measurement of bimanual performance in pre-established tasks	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.
Primary Outcome_2. Change from baseline Children's Hand-use Experience Questionnaire measure. Measurement of bimanual performance in activities of daily living.	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

Name	Time	Method
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).	Structure and function measurement: Neurological Hand Deformity Classification. This tools classify the deformity levels taking into account the wrist, fingers.
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).	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).
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).	Activity measurement: Box and Blocks Test assesses unilateral gross manual dexterity.
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).	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.
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).	Structure and function measurement: House Thumb in Palm Deformity Classification. This tool classify the deformity levels taking into account the structure of the thumb.

Trial Locations

Locations (2)

Universidad San Jorge; 🇪🇸 Zaragoza, Spain

AIDIMO Asociación para la investigación en la discapacidad motriz; 🇪🇸 Zaragoza, Spain