Working Memory Training for Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02119364
• Other study ID #: 2012/2/00|14
• Status: Recruiting
• Phase: N/A
• First received: April 3, 2013
• Last updated: April 17, 2014
• Start date: October 2013
• Est. completion date: December 2016

Study information

• Verified date: April 2014
• Source: Sorlandet Hospital HF
• Contact: Gro CC Lohaugen, Phd
• Phone: +47 95844805
• Email: gro.c.lohaugen[@]ntnu.no
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 115
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 15 Years

Eligibility

Inclusion Criteria:

• Cerebral Palsy

• School age (7-15 years of age)

Exclusion Criteria:

• Not able to use computer, blind, deaf

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Working memory training
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.

Locations

Country	Name	City	State
Norway	Sorlandet Hospital	Arendal	Aust-Agder

Sponsors (2)

Lead Sponsor	Collaborator
Sorlandet Hospital HF	Helse Sor-Ost

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Attention Deficit Hyperactivity Disorder rating scale	To assess changes in symptoms of attention/hyperactivity problems after training.	9-12 weeks after inclusion	No
Other	Activity of daily life	Vineland adaptive behaviour scale is a semi-structured parental interview assessing daily life functioning.	9-12 weeks after inclusion	No
Other	Attention/executive functions assessed by parents	BRIEF is a parental questionnaire that assesses aspects of attention and executive function in daily life.	9-12 weeks after inclusion	No
Primary	Spatial span	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	No
Secondary	Verbal working memory	The sum of letter-number sequencing and digit span (total raw scores) will be used as secondary outcome measures.	9-12 weeks after inclusion	No