Working Memory Training for Children With Cerebral Palsy

April 17, 2014 updated by: Sorlandet Hospital HF

Computer Based Working Memory Training in Children With Cerebral Palsy (CP)

Cerebral palsy (CP) is the most common motor disability in childhood (2-3 per 1000 live born), and is frequently accompanied by cognitive impairments and behavioural problems. The present study is a controlled clinical trial, a multicenter-study involving three health regions, as well as the Norwegian University of Science and Technology (NTNU). Its primary research goal will be to evaluate the effects of computer-based cognitive training in children with CP. In addition, this study will be the first to conduct a comprehensive neuropsychological examination to improve our understanding of cognitive impairments as well as cognitive resources in CP children in Norway to aid in intervention planning.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Aust-Agder
      • Arendal, Aust-Agder, Norway, 4801
        • Recruiting
        • Sorlandet hospital
        • Contact:
        • Principal Investigator:
          • Gro CC Lohaugen, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cerebral Palsy
  • School age (7-15 years of age)

Exclusion Criteria:

  • Not able to use computer, blind, deaf

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Working memory training
After baseline assessment participants will be randomized to active training or treatment as usual (waiting). The active group will start training immediately and will have 6 weeks to perform the 25 training sessions.
The child will use the computer program at home under parental supervision for 25 sessions, each lasting 30-45 minutes and the family has 6 weeks to complete the training. Each session consists of 8 different tasks presented by an animated robot. The tasks all require the child to hold information in working memory and to manipulate the information.
Other Names:
  • Cogmed RoboMemo
NO_INTERVENTION: Passive control group
The control group will receive "treatment as usual" (special education, physiotherapy etc).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spatial span
Time Frame: 9-12 weeks after inclusion
The spatial span board from the Wechsler Memory scale 3ed. will represent our primary outcome measure. The total of forward and backward span will be used as primary outcome measure.
9-12 weeks after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verbal working memory
Time Frame: 9-12 weeks after inclusion
The sum of letter-number sequencing and digit span (total raw scores) will be used as secondary outcome measures.
9-12 weeks after inclusion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attention Deficit Hyperactivity Disorder rating scale
Time Frame: 9-12 weeks after inclusion
To assess changes in symptoms of attention/hyperactivity problems after training.
9-12 weeks after inclusion
Activity of daily life
Time Frame: 9-12 weeks after inclusion
Vineland adaptive behaviour scale is a semi-structured parental interview assessing daily life functioning.
9-12 weeks after inclusion
Attention/executive functions assessed by parents
Time Frame: 9-12 weeks after inclusion
BRIEF is a parental questionnaire that assesses aspects of attention and executive function in daily life.
9-12 weeks after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Gro CC Lohaugen, Phd, Department of Child rehabilitation, Sørlandet Hospital, Arendal, Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

April 3, 2013

First Submitted That Met QC Criteria

April 17, 2014

First Posted (ESTIMATE)

April 21, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 17, 2014

Last Verified

April 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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