Clinical trial NCT03282422: Effectiveness of the Functional Hand Splint and Specific Tasks in the Domiciliary Environment Applied to Children With Unilateral Cerebral Palsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia and Hemiparesis
Cerebral Palsy Infantile
Keywords: Cerebral palsy
Hemiplegia
Upper-limb splint
Home-based
Social Participation
Lead sponsor: Universidad San Jorge
Sponsor class: OTHER
Collaborators: name: AIDIMO Asociación para la investigación en la discapacidad motriz
First posted: 2017-09-14
Enrollment: 33
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.

Eligibility 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 ...).

Primary outcomes:
measure: Primary Outcome_Change from baseline Assisting Hand Assessment measure. Measurement of bimanual performance in pre-established tasks
timeFrame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
measure: Primary Outcome_2. Change from baseline Children's Hand-use Experience Questionnaire measure. Measurement of bimanual performance in activities of daily living.
timeFrame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary outcomes:
measure: Secondary Outcome_Change from baseline Box and Blocks Test measure. Measurement of unilateral gross manual dexterity.
timeFrame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
measure: 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.
timeFrame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
measure: Secondary Outcome_3. Change from baseline House Thumb in Palm Deformity Classification. Classify the deformity level of thumb.
timeFrame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
measure: Secondary Outcome_4. Change from baseline Neurological Hand Deformity Classification. This tool classify the deformity levels of wrist and fingers.
timeFrame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
measure: Secondary Outcome_5. Change from baseline Grip and Pinch Strength measure. Measurement of pinch, wrist and foream strength.
timeFrame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: AIDIMO Asociación para la investigación en la discapacidad motriz
city: Zaragoza
country: Spain
facility: Universidad San Jorge
Study officials:
affiliation: Universidad San Jorge
name: María Ortiz Lucas, PhD
role: STUDY_DIRECTOR
affiliation: Universidad Europea de Madrid
name: Vanesa Abuín Porras, PhD
role: STUDY_DIRECTOR
affiliation: Universidad San Jorge
name: Patricia Roldán Pérez, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1017/s001216220500112x.
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. doi: 10.1017/S0012162206001666.
citation: Arner M, Eliasson AC, Nicklasson S, Sommerstein K, Hagglund 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.
citation: Malagon Valdez J. [Cerebral palsy]. Medicina (B Aires). 2007;67(6 Pt 1):586-92. Spanish.
citation: Kolb B, Whishaw IQ. Neuropsicología humana: Ed. Médica Panamericana; 2006.
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. doi: 10.1055/s-2007-973499.
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. Spanish.
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.
citation: Pueyo-Benito R, Vendrell-Gomez P, Bargallo-Alabart N, Mercader-Sobreques JM. [Neuroimaging and cerebral palsy]. Rev Neurol. 2002 Sep 1-15;35(5):463-9. Spanish.
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.
citation: Koman LA, Gelberman RH, Toby EB, Poehling GG. Cerebral palsy. Management of the upper extremity. Clin Orthop Relat Res. 1990 Apr;(253):62-74.
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.
citation: Elliott C, Reid S, Hamer P, Alderson J, Elliott B. Lycra((R)) 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.
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. doi: 10.1017/S0012162206001186.
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. doi: 10.1017/s0012162201001943. No abstract available.
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.
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.
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. doi: 10.5014/ajot.61.1.79.
citation: Eliasson AC, Krumlinde-Sundholm L, Rosblad 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. doi: 10.1017/S0012162206001162.
citation: Ohrvall 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.
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.
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. doi: 10.1017/S0012162206000934.
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.
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.
citation: 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. doi: 10.5014/ajot.40.10.705.
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.
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.
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.
citation: 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.
citation: Skold 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.
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. No abstract available.
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.
citation: 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.