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This is a comparative study where two protocols of intensive therapies will be applied to study the improvements in the functional performance of the affected upper limb of children with hemiparesis and check whether to increase their quality of life.
the intervention protocols combine different doses of intensive therapy, being 80 hours of modified constraint induced movement therapy followed by 20 hours for protocol 1 and protocol 2 would be the application of protocol 1 inverted, with this, the investigators want to compare how both protocols interfere in the function of the affected upper limb of children with different levels of bimanual functional performance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low performance group 1 | Experimental | Protocol 1 will be the intervention administered with 80 h modified constraint induced movement therapy and 20 h bimanual intensive therapy |
|
| low performance group 2 | Experimental | Protocol 2 will be the intervention administered with 80h bimanual intensive therapy and 20h modified constraint induced movement therapy |
|
| moderate-high performance group1 | Experimental | Protocol 1 will be the intervention administered with 80 h modified constraint induced movement therapy and 20 h bimanual intensive therapy |
|
| moderate-high performance group 2 | Experimental | Protocol 2 will be the intervention administered with 80h bimanual intensive therapy and 20h modified constraint induced movement therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intensive therapies(CIMT/BIT): protocol 1 or protocol 2 | Combination Product | The therapies applied in both protocols are intensive therapies that allow the execution of unimanual activities or bimanual activities with the affected upper limb with different doses. the protocols were carried out at home through the family |
| Measure | Description | Time Frame |
|---|---|---|
| bimanual functional performance, "change" is being assessed | use of the affected upper extremity of spontaneous character during bimanual activities. It is used the AHA assessment to measure it. | 4 assessments will be carried out in the research in 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life ,"change" is being assessed | This measure will be assessed with the pedsQL questionnaire | 4 assessments will be carried out in the research in 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
- Diseases not associated with infantile hemiparesis.
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| Name | Affiliation | Role |
|---|---|---|
| RocÃo Palomo Carrión | Salamanca University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RocÃo Palomo Carrión | Torrijos | Toledo | 45500 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29050511 | Result | Tervahauta MH, Girolami GL, Oberg GK. Efficacy of constraint-induced movement therapy compared with bimanual intensive training in children with unilateral cerebral palsy: a systematic review. Clin Rehabil. 2017 Nov;31(11):1445-1456. doi: 10.1177/0269215517698834. Epub 2017 Mar 20. | |
| 28953170 | Result | Klepper SE, Clayton Krasinski D, Gilb MC, Khalil N. Comparing Unimanual and Bimanual Training in Upper Extremity Function in Children With Unilateral Cerebral Palsy. Pediatr Phys Ther. 2017 Oct;29(4):288-306. doi: 10.1097/PEP.0000000000000438. |
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| ID | Term |
|---|---|
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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|
| 27022371 | Result | Zafer H, Amjad I, Malik AN, Shaukat E. Effectiveness of Constraint induced movement therapy as compared to bimanual therapy in Upper motor function outcome in child with hemiplegic Cerebral palsy. Pak J Med Sci. 2016 Jan-Feb;32(1):181-4. doi: 10.12669/pjms.321.8491. |
| 26164301 | Result | Geerdink Y, Aarts P, van der Burg J, Steenbergen B, Geurts A. Intensive upper limb intervention with self-management training is feasible and promising for older children and adolescents with unilateral cerebral palsy. Res Dev Disabil. 2015 Aug-Sep;43-44:97-105. doi: 10.1016/j.ridd.2015.06.013. Epub 2015 Jul 9. |
| 24983295 | Result | Gelkop N, Burshtein DG, Lahav A, Brezner A, Al-Oraibi S, Ferre CL, Gordon AM. Efficacy of constraint-induced movement therapy and bimanual training in children with hemiplegic cerebral palsy in an educational setting. Phys Occup Ther Pediatr. 2015 Feb;35(1):24-39. doi: 10.3109/01942638.2014.925027. Epub 2014 Jul 1. |
| 24820334 | Result | Sakzewski L, Gordon A, Eliasson AC. The state of the evidence for intensive upper limb therapy approaches for children with unilateral cerebral palsy. J Child Neurol. 2014 Aug;29(8):1077-90. doi: 10.1177/0883073814533150. Epub 2014 May 11. |
| 37139775 | Derived | Palomo-Carrion R, Ferri-Morales A, Ando-LaFuente S, Fernandez RA, Arenillas JIC, Anton-Anton V, Esteban EB. Constraint-induced movement therapy versus bimanual intensive therapy in children with hemiplegia showing low/very low bimanual functional performance: A randomized clinical trial. PM R. 2023 Dec;15(12):1536-1546. doi: 10.1002/pmrj.12990. Epub 2023 Jun 19. |
| 34408823 | Derived | Palomo-Carrion R, Lirio-Romero C, Ferri-Morales A, Jovellar-Isiegas P, Cortes-Vega MD, Romay-Barrero H. Combined intensive therapies at home in spastic unilateral cerebral palsy with high bimanual functional performance. What do they offer? A comparative randomised clinical trial. Ther Adv Chronic Dis. 2021 Aug 12;12:20406223211034996. doi: 10.1177/20406223211034996. eCollection 2021. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |