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Working Memory Training in Children With Cerebral Palsy, a Pilot Study

Primary Purpose

Cerebral Palsy, Working Memory Training

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cogmed Robomemo working memory training
Sponsored by
Helse Stavanger HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

7 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Born at term with unilateral spastic CP
  • Born preterm with bilateral spastic CP

Exclusion Criteria:

  • Children with Gross Motor Function Classification Scale (GMFCS) level V
  • Severe visual or hearing impairments
  • Photosensitive epilepsy

Sites / Locations

  • Stavanger University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cogmed Robomemo working memory training

Arm Description

Participants will complete 25 sessions (5 weeks) of Cogmed Robomemo (Pearson assessment) working memory training

Outcomes

Primary Outcome Measures

Changes in training index
The training index is based on the user's best results from selected exercises in the program. The Start Index is calculated with the results from days 2 and 3, and the Max Index is calculated with the results from the two best days during the training period. The Index Improvement is calculated by subtracting the Start Index from the Max Index.

Secondary Outcome Measures

Neuropsychological testing

Full Information

First Posted
August 9, 2012
Last Updated
October 7, 2014
Sponsor
Helse Stavanger HF
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1. Study Identification

Unique Protocol Identification Number
NCT01663454
Brief Title
Working Memory Training in Children With Cerebral Palsy, a Pilot Study
Official Title
Computer Based Working Memory Training in Children With Cerebral Palsy, a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this pilot study is to assist the preparation of a larger multi-center study. The main aim is to determine the feasibility of conducting computerized working memory training in a group of children with cerebral palsy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Working Memory Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cogmed Robomemo working memory training
Arm Type
Experimental
Arm Description
Participants will complete 25 sessions (5 weeks) of Cogmed Robomemo (Pearson assessment) working memory training
Intervention Type
Behavioral
Intervention Name(s)
Cogmed Robomemo working memory training
Intervention Description
The Cogmed Robomemo program is designed as a computer game in which an animated robot gives different tasks to be solved by the child. The tasks have various degrees of difficulty adapted continuously throughout the intervention period to the performance of the individual child. The program is standardized in that each child receives the same set of tasks during the training period. The child will perform the training sessions at home using their own computer for about 35-40 minutes each day.
Primary Outcome Measure Information:
Title
Changes in training index
Description
The training index is based on the user's best results from selected exercises in the program. The Start Index is calculated with the results from days 2 and 3, and the Max Index is calculated with the results from the two best days during the training period. The Index Improvement is calculated by subtracting the Start Index from the Max Index.
Time Frame
Changes in training index is measured during 5 weeks of working memory training
Secondary Outcome Measure Information:
Title
Neuropsychological testing
Time Frame
baseline and 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Born at term with unilateral spastic CP Born preterm with bilateral spastic CP Exclusion Criteria: Children with Gross Motor Function Classification Scale (GMFCS) level V Severe visual or hearing impairments Photosensitive epilepsy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harald Beneventi, PhD
Organizational Affiliation
Helse Stavanger HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stavanger University Hospital
City
Stavanger
ZIP/Postal Code
4011
Country
Norway

12. IPD Sharing Statement

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Working Memory Training in Children With Cerebral Palsy, a Pilot Study

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