Intensive Therapies in Children With Hemiplegia (CIMT/BIT)

University of Salamanca

Status: Completed

Conditions: Infantile Hemiplegia

Treatments: Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2

Study type: Interventional

Funder types: Other

Identifiers

NCT03465046

nº11, thesis SDDB USAL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 5 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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41 participants in 4 patient groups

low performance group 1

Experimental group

Description:

Protocol 1 will be the intervention administered with 80 h modified constraint induced movement therapy and 20 h bimanual intensive therapy

Treatment:

Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2

low performance group 2

Experimental group

Description:

Protocol 2 will be the intervention administered with 80h bimanual intensive therapy and 20h modified constraint induced movement therapy

Treatment:

Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2

moderate-high performance group1

Experimental group

Description:

Protocol 1 will be the intervention administered with 80 h modified constraint induced movement therapy and 20 h bimanual intensive therapy

Treatment:

Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2

moderate-high performance group 2

Experimental group

Description:

Protocol 2 will be the intervention administered with 80h bimanual intensive therapy and 20h modified constraint induced movement therapy

Treatment:

Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2