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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03282422
Other study ID # FF_TE_01_Versión 3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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 ...).

Study Design


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

Arner M, Eliasson AC, Nicklasson S, Sommerstein K, Hägglund G. Hand function in cerebral palsy. Report of 367 children in a population-based longitudinal health care program. J Hand Surg Am. 2008 Oct;33(8):1337-47. doi: 10.1016/j.jhsa.2008.02.032. — View Citation

Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. Review. — View Citation

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

Cioni G, Sales B, Paolicelli PB, Petacchi E, Scusa MF, Canapicchi R. MRI and clinical characteristics of children with hemiplegic cerebral palsy. Neuropediatrics. 1999 Oct;30(5):249-55. — View Citation

Eliasson AC, Krumlinde-Sundholm L, Rösblad B, Beckung E, Arner M, Ohrvall AM, Rosenbaum P. The Manual Ability Classification System (MACS) for children with cerebral palsy: scale development and evidence of validity and reliability. Dev Med Child Neurol. 2006 Jul;48(7):549-54. — View Citation

Elliott C, Reid S, Hamer P, Alderson J, Elliott B. Lycra(®) arm splints improve movement fluency in children with cerebral palsy. Gait Posture. 2011 Feb;33(2):214-9. doi: 10.1016/j.gaitpost.2010.11.008. Epub 2010 Dec 4. — View Citation

Georgiades M, Elliott C, Wilton J, Blair E, Blackmore M, Garbellini S. The Neurological Hand Deformity Classification for children with cerebral palsy. Aust Occup Ther J. 2014 Dec;61(6):394-402. doi: 10.1111/1440-1630.12150. Epub 2014 Aug 29. — View Citation

Hepping AM, Ploegmakers JJ, Geertzen JH, Bulstra SK, Stevens M. The Influence of Hand Preference on Grip Strength in Children and Adolescents; A Cross-Sectional Study of 2284 Children and Adolescents. PLoS One. 2015 Nov 23;10(11):e0143476. doi: 10.1371/journal.pone.0143476. eCollection 2015. — View Citation

Himmelmann K, Uvebrant P. The panorama of cerebral palsy in Sweden. XI. Changing patterns in the birth-year period 2003-2006. Acta Paediatr. 2014 Jun;103(6):618-24. doi: 10.1111/apa.12614. Epub 2014 Mar 24. — View Citation

Holmefur M, Aarts P, Hoare B, Krumlinde-Sundholm L. Test-retest and alternate forms reliability of the assisting hand assessment. J Rehabil Med. 2009 Nov;41(11):886-91. doi: 10.2340/16501977-0448. — View Citation

Holmefur M, Krumlinde-Sundholm L, Eliasson AC. Interrater and intrarater reliability of the Assisting Hand Assessment. Am J Occup Ther. 2007 Jan-Feb;61(1):79-84. — View Citation

House JH, Gwathmey FW, Fidler MO. A dynamic approach to the thumb-in palm deformity in cerebral palsy. J Bone Joint Surg Am. 1981 Feb;63(2):216-25. — View Citation

Jebsen RH, Taylor N, Trieschmann RB, Trotter MJ, Howard LA. An objective and standardized test of hand function. Arch Phys Med Rehabil. 1969 Jun;50(6):311-9. — View Citation

Jongbloed-Pereboom M, Nijhuis-van der Sanden MW, Steenbergen B. Norm scores of the box and block test for children ages 3-10 years. Am J Occup Ther. 2013 May-Jun;67(3):312-8. doi: 10.5014/ajot.2013.006643. — View Citation

Kolb B, Whishaw IQ. Neuropsicología humana: Ed. Médica Panamericana; 2006.

Koman LA, Gelberman RH, Toby EB, Poehling GG. Cerebral palsy. Management of the upper extremity. Clin Orthop Relat Res. 1990 Apr;(253):62-74. Review. — View Citation

Louwers A, Beelen A, Holmefur M, Krumlinde-Sundholm L. Development of the Assisting Hand Assessment for adolescents (Ad-AHA) and validation of the AHA from 18 months to 18 years. Dev Med Child Neurol. 2016 Dec;58(12):1303-1309. doi: 10.1111/dmcn.13168. Epub 2016 Jun 13. — View Citation

Malagón Valdez J. [Cerebral palsy]. Medicina (B Aires). 2007;67(6 Pt 1):586-92. Review. Spanish. — View Citation

Mathiowetz V, Federman S, Wiemer D. Box and block test of manual dexterity: norms for 6-19 year olds 52(5):241-5, 1985.

Mathiowetz V, Wiemer DM, Federman SM. Grip and pinch strength: norms for 6- to 19-year-olds. Am J Occup Ther. 1986 Oct;40(10):705-11. — View Citation

Morris C. A review of the efficacy of lower-limb orthoses used for cerebral palsy. Dev Med Child Neurol. 2002 Mar;44(3):205-11. Review. — View Citation

Novak I, Cusick A, Lannin N. Occupational therapy home programs for cerebral palsy: double-blind, randomized, controlled trial. Pediatrics. 2009 Oct;124(4):e606-14. doi: 10.1542/peds.2009-0288. Epub 2009 Sep 21. — View Citation

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

Ozer K, Chesher SP, Scheker LR. Neuromuscular electrical stimulation and dynamic bracing for the management of upper-extremity spasticity in children with cerebral palsy. Dev Med Child Neurol. 2006 Jul;48(7):559-63. — View Citation

Palisano RJ, Cameron D, Rosenbaum PL, Walter SD, Russell D. Stability of the gross motor function classification system. Dev Med Child Neurol. 2006 Jun;48(6):424-8. — View Citation

Pueyo-Benito R, Vendrell-Gómez P, Bargalló-Alabart N, Mercader-Sobrequés JM. [Neuroimaging and cerebral palsy]. Rev Neurol. 2002 Sep 1-15;35(5):463-9. Review. Spanish. — View Citation

Robaina-Castellanos GR, Riesgo-Rodriguez S, Robaina-Castellanos MS. [Definition and classification of cerebral palsy: a problem that has already been solved?]. Rev Neurol. 2007 Jul 16-31;45(2):110-7. Review. Spanish. — View Citation

Rosenbaum PL, Palisano RJ, Bartlett DJ, Galuppi BE, Russell DJ. Development of the Gross Motor Function Classification System for cerebral palsy. Dev Med Child Neurol. 2008 Apr;50(4):249-53. doi: 10.1111/j.1469-8749.2008.02045.x. Epub 2008 Mar 1. — View Citation

Sears ED, Chung KC. Validity and responsiveness of the Jebsen-Taylor Hand Function Test. J Hand Surg Am. 2010 Jan;35(1):30-7. doi: 10.1016/j.jhsa.2009.09.008. Epub 2009 Dec 2. — View Citation

Sköld A, Hermansson LN, Krumlinde-Sundholm L, Eliasson AC. Development and evidence of validity for the Children's Hand-use Experience Questionnaire (CHEQ). Dev Med Child Neurol. 2011 May;53(5):436-42. doi: 10.1111/j.1469-8749.2010.03896.x. Epub 2011 Mar 17. — View Citation

Steenbergen B, Gordon AM. Activity limitation in hemiplegic cerebral palsy: evidence for disorders in motor planning. Dev Med Child Neurol. 2006 Sep;48(9):780-3. Review. — View Citation

* Note: There are 32 references in allClick 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).
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