Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2018-10-15
2019-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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low performance group 1
Protocol 1 will be the intervention administered with 80 h modified constraint induced movement therapy and 20 h bimanual intensive therapy
intensive therapies(CIMT/BIT): protocol 1 or protocol 2
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
low performance group 2
Protocol 2 will be the intervention administered with 80h bimanual intensive therapy and 20h modified constraint induced movement therapy
intensive therapies(CIMT/BIT): protocol 1 or protocol 2
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
moderate-high performance group1
Protocol 1 will be the intervention administered with 80 h modified constraint induced movement therapy and 20 h bimanual intensive therapy
intensive therapies(CIMT/BIT): protocol 1 or protocol 2
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
moderate-high performance group 2
Protocol 2 will be the intervention administered with 80h bimanual intensive therapy and 20h modified constraint induced movement therapy
intensive therapies(CIMT/BIT): protocol 1 or protocol 2
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
Interventions
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intensive therapies(CIMT/BIT): protocol 1 or protocol 2
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
Eligibility Criteria
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Inclusion Criteria
* Ages between 5 to 10 years.
* Levels of I-III within the , manual ability classification system, MACS.
* Levels of I-III within the gross motor function classification system, GMFCS
Exclusion Criteria
* Low cognitive level to understand the execution of activities.
* Surgeries of the upper extremity during the 6 months prior to the intervention.
* Structured contractures in the affected upper extremity that cause functional impotence.
* Botulinum toxin two months prior to the intervention and application of it during the treatment.
* Epilepsy not controlled pharmacologically
5 Years
10 Years
ALL
No
Sponsors
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University of Salamanca
OTHER
Responsible Party
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Rocío Palomo Carrión
physiotherapist
Principal Investigators
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Rocío Palomo Carrión
Role: PRINCIPAL_INVESTIGATOR
Salamanca University
Locations
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Rocío Palomo Carrión
Torrijos, Toledo, Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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nº11, thesis SDDB USAL
Identifier Type: -
Identifier Source: org_study_id