Cerebral PalsyNCT01663454
Working Memory Training in Children With Cerebral Palsy, a Pilot Study
A study testing Cogmed Robomemo working memory training in people with Cerebral Palsy and Working Memory Training, run by Helse Stavanger HF at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 8 years
- Conditions the study is for
- Cerebral Palsy, Working Memory Training
- What is being tested?
- Cogmed Robomemo working memory training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born at term with unilateral spastic CP
- Born preterm with bilateral spastic CP
Who cannot join
- Children with Gross Motor Function Classification Scale (GMFCS) level V
- Severe visual or hearing impairments
- Photosensitive epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computer Based Working Memory Training in Children With Cerebral Palsy, a Pilot Study
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.
- Conditions
- Cerebral Palsy, Working Memory Training
- Being tested
- Cogmed Robomemo working memory training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cogmed Robomemo working memory trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cogmed Robomemo working memory training | Experimental | Participants will complete 25 sessions (5 weeks) of Cogmed Robomemo (Pearson assessment) working memory training Receives: Behavioral: Cogmed Robomemo working memory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Changes in training index is measured during 5 weeks of working memory training
Secondary outcomes (1)
Neuropsychological testing
Measured: baseline and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Harald Beneventi, PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663454
- Sponsor's protocol ID
- bhø_2011/2271
- Status last verified
- Oct 2014
- First submitted
- 9 Aug 2012
- Last updated
- 8 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Based Working Memory Training in Children With Cerebral Palsy, a Pilot Study
- ClinicalTrials.gov ID
- NCT01663454
- Acronym / sponsor ID
- bhø_2011/2271
- Conditions
- Cerebral Palsy, Working Memory Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cogmed Robomemo working memory training | Experimental | Behavioral: Cogmed Robomemo working memory trainingParticipants will complete 25 sessions (5 weeks) of Cogmed Robomemo (Pearson assessment) working memory training |
Who may qualify
- Ages
- 7 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Born at term with unilateral spastic CP
- Born preterm with bilateral spastic CP
Key exclusion criteria (3 listed)
- Children with Gross Motor Function Classification Scale (GMFCS) level V
- Severe visual or hearing impairments
- Photosensitive epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cogmed Robomemo working memory trainingThe 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. | Behavioural | Cogmed Robomemo working memory training |
Primary outcome
Changes in training index
Time frame: Changes in training index is measured during 5 weeks of working memory training
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.
1 secondary outcome
Neuropsychological testing
Time frame: baseline and 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harald Beneventi, PhD principal investigator
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cogmed Robomemo working memory training in people with Cerebral Palsy and Working Memory Training, run by Helse Stavanger HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in training index (time frame: Changes in training index is measured during 5 weeks of working memory training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2014.