- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02119364
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
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
- Name: Gro CC Lohaugen, Phd
- Phone Number: +47 95844805
- Email: gro.c.lohaugen@ntnu.no
Study Contact Backup
- Name: Jon S Skranes, Phd
- Phone Number: +47 99390285
- Email: jon.skranes@ntnu.no
Study Locations
-
-
Aust-Agder
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Arendal, Aust-Agder, Norway, 4801
- Recruiting
- Sorlandet hospital
-
Contact:
- Gro Lohaugen, Phd
- Phone Number: +4795844805
- Email: gro.c.lohaugen@ntnu.no
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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.
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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:
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NO_INTERVENTION: Passive control group
The control group will receive "treatment as usual" (special education, physiotherapy etc).
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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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012/2/00|14
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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