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Completed

NCT Number: NCT04425980

The Efficacy of Two Models of Intensive Upper Limb Training on Quality of Life in Children With Congenital Hemiplegia

This study compared the effectiveness of two-mode of activity-based upper limb rehabilitation (Modified Constraint-Induced Movement Therapy and Bimanual training) on health-related quality of life outcomes in school-aged children with cerebral palsy

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Key information

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mus Alparslan University

Muş, 49100, Turkey (Türkiye)

About this study

A total of 52 primary schools were screened comprehensively to determine children conforming specifications of the inclusion criteria. Demographic characteristics (e.g. age, gender, affected side) and severity of functional impairment dealing with cognitive /communication, manual ability and mobility were noted. After a comprehensive screening, a total of 30 children met inclusion criteria (grades 1-4) were randomly assigned to one of two groups (Modified Constraint-Induced Movement Therapy or Bimanual training), at an equal number and probability. Children blinded to group allocation were delivered activity-based upper limb training in the context of Modified Constraint-Induced Movement Therapy or Bimanual training, at a similar dose and frequency (10 weeks/3 days per week/2.5 hours per day). 1 out of 3 sessions per week was carried out in the school time (during the art or physical education class), while 2 out of 3 sessions were carried out in rehabilitation centers which the children regularly attend for regular care 2-day weekly. All participating children continued to receive their standard care (90 minutes per week) throughout the study period.

During the 1-month screening period, physical characteristics of participants were described through classification systems including The Communication Function Classification System, The Manual Ability Classification System , and The Gross Motor Function Classification System. Participating children were evaluated before the study entry (T1), immediately postintervention (T2), and at 16 weeks postintervention (T3) using the KIDSCREEN-27 questionnaire

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Clinical diagnosis of congenital hemiplegia,
  • Must be able to grasp objects

Exclusion criteria

  • Cerebral palsy dependent severe emotional difficulties

Treatment and study plan

Modified Constraint-Induced Movement Therapy

Other

intensive use of more affected arm in structured setting

Primary outcomes

  1. Change from baseline in quality of life on the 5 point KIDSCREEN-27 questionnaire at post intervention

    Time frame: From baeline to post-intervention, up to 16 weeks

    The KIDSCREEN instruments have been established to report various subdomains of QOL about physical, emotional, mental and social well-being in school-aged children and adolescents

Sponsors and collaborators

Lead sponsor

Muş Alparslan University

Other

Registry information

Official study title

The Efficacy of Two Models of Intensive Upper Limb Training On Quality of Life in Children With Hemiplegic Cerebral Palsy Attending Regular School in Mus Province: A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 11, 2020
Registry last updated
Mar 9, 2021

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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