Intensive Therapies in Children With Hemiplegia

Infantile Hemiplegia Clinical Trial

— CIMT/BIT  

Official title:

Modified Constraint Induced Movement Therapy and Bimanual Intensive Therapy in Children With Hemiplegia. Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03465046
• Other study ID #: nº11, thesis SDDB USAL
• Status: Completed
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: January 30, 2019

Study information

• Verified date: November 2020
• Source: University of Salamanca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 30, 2019
• Est. primary completion date: November 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

Inclusion Criteria:

• Children diagnosed with Unilateral Infantile Cerebral Palsy, Congenital Infantile Hemiparesis.
• 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:

• Diseases not associated with infantile hemiparesis.
• 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

Related Conditions & MeSH terms

• Hemiplegia
• Infantile Hemiplegia

Intervention

Combination Product:
• 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

Locations

Country	Name	City	State
Spain	Rocío Palomo Carrión	Torrijos	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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: — View Citation

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( — View Citation

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. Review. — View Citation

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. Review. — View Citation

Tervahauta MH, Girolami GL, Øberg 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: 10.1177/02692155 — View Citation

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/pjm — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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