NCT01663454

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 8, 2014

Status Verified

October 1, 2014

Enrollment Period

3 months

First QC Date

August 9, 2012

Last Update Submit

October 7, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Changes in training index is measured during 5 weeks of working memory training

Secondary Outcomes (1)

  • Neuropsychological testing

    baseline and 2 months

Study Arms (1)

Cogmed Robomemo working memory training

EXPERIMENTAL

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

Behavioral: Cogmed Robomemo working memory training

Interventions

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.

Cogmed Robomemo working memory training

Eligibility Criteria

Age7 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavanger University Hospital

Stavanger, 4011, Norway

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Harald Beneventi, PhD

    Helse Stavanger HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2012

First Posted

August 13, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

October 8, 2014

Record last verified: 2014-10

Locations