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

This study is enrolling participants by invitation only.
Sponsor:
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
History of Changes
  Purpose

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.


Condition Intervention
Cerebral Palsy
Working Memory Training
 Behavioral: Cogmed Robomemo working memory training

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Computer Based Working Memory Training in Children With Cerebral Palsy, a Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Neuropsychological testing [ Time Frame: baseline and 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: September 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cogmed Robomemo working memory training
Participants will complete 25 sessions (5 weeks) of Cogmed Robomemo (Pearson assessment) working memory training
 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.

  Eligibility

Ages Eligible for Study:   7 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663454

Locations
Norway
Stavanger University Hospital
Stavanger, Norway, 4011
Sponsors and Collaborators
Helse Stavanger HF
Investigators
Principal Investigator: Harald Beneventi, PhD Helse Stavanger HF
  More Information

No publications provided

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01663454     History of Changes
Other Study ID Numbers: bhø_2011/2271
Study First Received: August 9, 2012
Last Updated: August 13, 2012
Health Authority: Norway: Ethics Committee

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013