Working Memory Training in Children With Cerebral Palsy, a Pilot Study
This study is enrolling participants by invitation only.
Sponsor:
Helse Stavanger HF
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT01663454
First received: August 9, 2012
Last updated: August 13, 2012
Last verified: August 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 9, 2012 | ||||
| Last Updated Date | August 13, 2012 | ||||
| Start Date ICMJE | September 2012 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Changes in training index [ Time Frame: Changes in training index is measured during 5 weeks of working memory training ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01663454 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Neuropsychological testing [ Time Frame: baseline and 2 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Neuropsychological test results [ Time Frame: Testing will be accomplished 2-3 weeks after training ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Working Memory Training in Children With Cerebral Palsy, a Pilot Study | ||||
| Official Title ICMJE | Computer Based Working Memory Training in Children With Cerebral Palsy, a Pilot Study | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Cogmed Robomemo working memory training
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. |
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| Study Arm (s) | Experimental: Cogmed Robomemo working memory training
Participants will complete 25 sessions (5 weeks) of Cogmed Robomemo (Pearson assessment) working memory training
Intervention: Behavioral: Cogmed Robomemo working memory training |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 12 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 7 Years to 8 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01663454 | ||||
| Other Study ID Numbers ICMJE | bhø_2011/2271 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Helse Stavanger HF | ||||
| Study Sponsor ICMJE | Helse Stavanger HF | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Helse Stavanger HF | ||||
| Verification Date | August 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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