search
Back to results

Working Memory Training for Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Working memory training
Sponsored by
Sorlandet Hospital HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, working memory, cognitive training

Eligibility Criteria

7 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Not able to use computer, blind, deaf

Sites / Locations

  • Sorlandet HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Working memory training

Passive control group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Verbal working memory
The sum of letter-number sequencing and digit span (total raw scores) will be used as secondary outcome measures.

Full Information

First Posted
April 3, 2013
Last Updated
April 17, 2014
Sponsor
Sorlandet Hospital HF
Collaborators
Helse Sor-Ost
search

1. Study Identification

Unique Protocol Identification Number
NCT02119364
Brief Title
Working Memory Training for Children With Cerebral Palsy
Official Title
Computer Based Working Memory Training in Children With Cerebral Palsy (CP)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorlandet Hospital HF
Collaborators
Helse Sor-Ost

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy, working memory, cognitive training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Working memory training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Passive control group
Arm Type
No Intervention
Arm Description
The control group will receive "treatment as usual" (special education, physiotherapy etc).
Intervention Type
Other
Intervention Name(s)
Working memory training
Other Intervention Name(s)
Cogmed RoboMemo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Spatial span
Description
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.
Time Frame
9-12 weeks after inclusion
Secondary Outcome Measure Information:
Title
Verbal working memory
Description
The sum of letter-number sequencing and digit span (total raw scores) will be used as secondary outcome measures.
Time Frame
9-12 weeks after inclusion
Other Pre-specified Outcome Measures:
Title
Attention Deficit Hyperactivity Disorder rating scale
Description
To assess changes in symptoms of attention/hyperactivity problems after training.
Time Frame
9-12 weeks after inclusion
Title
Activity of daily life
Description
Vineland adaptive behaviour scale is a semi-structured parental interview assessing daily life functioning.
Time Frame
9-12 weeks after inclusion
Title
Attention/executive functions assessed by parents
Description
BRIEF is a parental questionnaire that assesses aspects of attention and executive function in daily life.
Time Frame
9-12 weeks after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cerebral Palsy School age (7-15 years of age) Exclusion Criteria: Not able to use computer, blind, deaf
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gro CC Lohaugen, Phd
Phone
+47 95844805
Email
gro.c.lohaugen@ntnu.no
First Name & Middle Initial & Last Name or Official Title & Degree
Jon S Skranes, Phd
Phone
+47 99390285
Email
jon.skranes@ntnu.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gro CC Lohaugen, Phd
Organizational Affiliation
Department of Child rehabilitation, Sørlandet Hospital, Arendal, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sorlandet Hospital
City
Arendal
State/Province
Aust-Agder
ZIP/Postal Code
4801
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gro Lohaugen, Phd
Phone
+4795844805
Email
gro.c.lohaugen@ntnu.no
First Name & Middle Initial & Last Name & Degree
Gro CC Lohaugen, Phd

12. IPD Sharing Statement

Citations:
PubMed Identifier
24998242
Citation
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.
Results Reference
derived

Learn more about this trial

Working Memory Training for Children With Cerebral Palsy

We'll reach out to this number within 24 hrs