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Completed

NCT Number: NCT03465046

Intensive Therapies in Children With Hemiplegia

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.

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Key information

Conditions

Infantile Hemiplegia Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rocío Palomo Carrión

Torrijos, Toledo, 45500, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. bimanual functional performance, "change" is being assessed

    Time frame: 4 assessments will be carried out in the research in 10 weeks

    use of the affected upper extremity of spontaneous character during bimanual activities. It is used the AHA assessment to measure it.

Secondary outcomes

  1. quality of life ,"change" is being assessed

    Time frame: 4 assessments will be carried out in the research in 10 weeks

    This measure will be assessed with the pedsQL questionnaire

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Official study title

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

Acronym: CIMT/BIT

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 14, 2018
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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