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

NCT04425980 | Completed

• 1 other identifier: no any sponsor
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemiplegia; Congenital

Outcome Measures

Primary Outcomes (1)

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

  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

  From baeline to post-intervention, up to 16 weeks

Study Arms (2)

Modified Constraint-Induced Movement Therapy (test treatments)

EXPERIMENTAL

A list of fine and motor activities consisted of the functional tasks or play activities such as school-education and sports activities, manipulative games, arts, and crafts, etc. to elicit the maximum capacity of the more affected upper limb was created according to the procedure of modified constraint-induced movement therapy (Gordon et al., 2005) and Bimanual training. In addition, specific activities were also chosen in terms of deficit of interest, participant preference (on the condition of having potential effects on hand skills) and parent/guardian, or their teacher's request. In case of activities requiring both hand use, such as stabilizing paper during the painting or holding the bricks of lego on the ground, the treating physiotherapist undertook a role as a dominant hand

Other: Modified Constraint-Induced Movement Therapy

Bimanual training

ACTIVE COMPARATOR

For the Bimanual training, skilled, repetitive, and structured bimanual activities (part or whole task practice) were used to promote bimanual hand use and improve movement deficits determined before the intervention. All targeted deficits of interest were addressed within the context of the selected activity. Specifically, symmetrical bilateral movements were utilized to augment neural input from both sides. Also, meaningful activities such as buttoning and zipping-up trousers, etc. were used to ensure a transition from structured setting to real-life activities

Other: Modified Constraint-Induced Movement Therapy

Interventions

Modified Constraint-Induced Movement Therapy OTHER

intensive use of more affected arm in structured setting

Bimanual training; Modified Constraint-Induced Movement Therapy (test treatments)

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Cerebral palsy dependent severe emotional difficulties

Sponsors & Collaborators

• Muş Alparslan University: lead

Study Sites (1)

Mus Alparslan University

Muş, Muş, 49100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

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

Study Officials

• Hasan Bingöl, MSc

  Muş Alparslan University

  PRINCIPAL INVESTIGATOR

• Mintaze Kerem Günel, PhD

  Hacettepe University

  STUDY CHAIR

• Halil ALKAN, PhD

  Muş Alparslan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: by concealing the other allocated intervention from participants / unaware of the presence of a second intervention approach
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academician (Lecturer

Model Details: 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

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 11, 2020
• Study Start: October 1, 2018
• Primary Completion: July 15, 2019
• Study Completion: February 15, 2020
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)