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| Name | Class |
|---|---|
| AIDIMO Asociación para la investigación en la discapacidad motriz | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Upper-limb splint and home-based protocol in specific tasks |
|
| Control group | Active Comparator | Home-based protocol in specific tasks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MarÃa Ortiz Lucas, PhD | Universidad San Jorge | Study Director |
| Vanesa AbuÃn Porras, PhD | Universidad Europea de Madrid | Study Director |
| Patricia Roldán Pérez, MSc | Universidad San Jorge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIDIMO Asociación para la investigación en la discapacidad motriz | Zaragoza | 50011 | Spain | |||
| Universidad San Jorge |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16108461 | Background | 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. | |
| 16904028 | Background |
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Randomized Controlled Trial
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|
| 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. |
|
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 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 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 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). |
| Zaragoza |
| 50830 |
| Spain |
| 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. |
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| 18422084 | Background | Malagon Valdez J. [Cerebral palsy]. Medicina (B Aires). 2007;67(6 Pt 1):586-92. Spanish. |
| Background | Kolb B, Whishaw IQ. NeuropsicologÃa humana: Ed. Médica Panamericana; 2006. |
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| 17642051 | Background | 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. |
| 24575788 | Background | 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. |
| 12373681 | Background | 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. |
| 18215750 | Background | 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. |
| 2180605 | Background | Koman LA, Gelberman RH, Toby EB, Poehling GG. Cerebral palsy. Management of the upper extremity. Clin Orthop Relat Res. 1990 Apr;(253):62-74. |
| 19770175 | Background | 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. |
| 21131201 | Background | 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. |
| 16780624 | Background | 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. |
| 12005323 | Background | 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. |
| 27291981 | Background | 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. |
| 19841839 | Background | 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. |
| 17302108 | Background | 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. |
| 16780622 | Background | 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. |
| 24417511 | Background | 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. |
| 18318732 | Background | 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. |
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| 25169815 | Background | 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. |
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| Background | Mathiowetz V, Federman S, Wiemer D. Box and block test of manual dexterity: norms for 6-19 year olds 52(5):241-5, 1985. |
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| 26610725 | Background | 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. |
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| 5788487 | Background | 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. |
| 19954898 | Background | 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. |
| 35822931 | Derived | 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. |
| ID | Term |
|---|---|
| D006429 | Hemiplegia |
| D010291 | Paresis |
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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