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Intensive Therapies in Children With Hemiplegia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03465046
Acronym
CIMT/BIT
Enrollment
41
Registered
2018-03-14
Start date
2018-10-15
Completion date
2019-01-30
Last updated
2020-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infantile Hemiplegia

Keywords

infantile hemiplegia, upper extremity, physical therapy

Brief 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.

Detailed 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.

Interventions

COMBINATION_PRODUCTintensive 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

Sponsors

University of Salamanca
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
bimanual functional performance, change is being assessed4 assessments will be carried out in the research in 10 weeksuse of the affected upper extremity of spontaneous character during bimanual activities. It is used the AHA assessment to measure it.

Secondary

MeasureTime frameDescription
quality of life ,change is being assessed4 assessments will be carried out in the research in 10 weeksThis measure will be assessed with the pedsQL questionnaire

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026