NCT02119364

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 21, 2014

Status Verified

April 1, 2014

Enrollment Period

3.2 years

First QC Date

April 3, 2013

Last Update Submit

April 17, 2014

Conditions

Cerebral Palsy

Keywords

cerebral palsyworking memorycognitive training

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Verbal working memory

    9-12 weeks after inclusion

Other Outcomes (3)

  • Attention Deficit Hyperactivity Disorder rating scale

    9-12 weeks after inclusion

  • Activity of daily life

    9-12 weeks after inclusion

  • Attention/executive functions assessed by parents

    9-12 weeks after inclusion

Study Arms (2)

Working memory training

ACTIVE COMPARATOR

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.

Other: Working memory training

Passive control group

NO INTERVENTION

The control group will receive "treatment as usual" (special education, physiotherapy etc).

Interventions

Working memory trainingOTHER

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.

Also known as: Cogmed RoboMemo
Working memory training

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Not able to use computer, blind, deaf

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sorlandet Hospital

Arendal, Aust-Agder, 4801, Norway

RECRUITING

Related Publications (1)

  • Lohaugen GC, Beneventi H, Andersen GL, Sundberg C, Ostgard HF, Bakkan E, Walther G, Vik T, Skranes J. Do children with cerebral palsy benefit from computerized working memory training? Study protocol for a randomized controlled trial. Trials. 2014 Jul 7;15:269. doi: 10.1186/1745-6215-15-269.

    PMID: 24998242DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Gro CC Lohaugen, Phd

    Department of Child rehabilitation, Sørlandet Hospital, Arendal, Norway

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gro CC Lohaugen, Phd

CONTACT

+47 95844805gro.c.lohaugen@ntnu.no

Jon S Skranes, Phd

CONTACT

+47 99390285jon.skranes@ntnu.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2013

First Posted

April 21, 2014

Study Start

October 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 21, 2014

Record last verified: 2014-04

Locations

NO(1)