Cerebral PalsyNCT02119364
Working Memory Training for Children With Cerebral Palsy
A study testing Working memory training in people with Cerebral Palsy, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
Cerebral palsy (CP) is the most common motor disability in childhood (2-3 per 1000 live born), and is frequently accompanied by cognitive impairments and behavioural problems. The present study is a controlled clinical trial, a multicenter-study involving three health regions, as well as the Norwegian University of… Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Working memory training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2013to Dec 2016
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cerebral Palsy
- School age (7-15 years of age)
Who cannot join
- Not able to use computer, blind, deaf
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Sorlandet Hospital
Arendal, Aust-Agder, 4801
Gro Lohaugen, Phd, +4795844805, gro.c.lohaugen@ntnu.no
Gro CC Lohaugen, Phd
About this study
Official title: Computer Based Working Memory Training in Children With Cerebral Palsy (CP)
Cerebral palsy (CP) is the most common motor disability in childhood (2-3 per 1000 live born), and is frequently accompanied by cognitive impairments and behavioural problems. The present study is a controlled clinical trial, a multicenter-study involving three health regions, as well as the Norwegian University of Science and Technology (NTNU). Its primary research goal will be to evaluate the effects of computer-based cognitive training in children with CP. In addition, this study will be the first to conduct a comprehensive neuropsychological examination to improve our understanding of cognitive impairments as well as cognitive resources in CP children in Norway to aid in intervention planning.
- Conditions
- Cerebral Palsy
- Being tested
- Working memory training
- Keywords
- cerebral palsy, working memory, cognitive 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.
Working memory trainingOther
Also called Cogmed RoboMemo
The child will use the computer program at home under parental supervision for 25 sessions, each lasting 30-45 minutes and the family has 6 weeks to complete the training. Each session consists of 8 different tasks presented by an animated robot. The tasks all require the child to hold information in working memory and to manipulate the information.
| Study group | Role | What they receive |
|---|---|---|
| Working memory training | Active comparator | After baseline assessment participants will be randomized to active training or treatment as usual (waiting). The active group will start training immediately and will have 6 weeks to perform the 25 training sessions. Receives: Other: Working memory training |
| Passive control group | No intervention | The control group will receive "treatment as usual" (special education, physiotherapy etc). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial span
The spatial span board from the Wechsler Memory scale 3ed. will represent our primary outcome measure. The total of forward and backward span will be used as primary outcome measure.
Measured: 9-12 weeks after inclusion
Secondary outcomes (1)
Verbal working memory
The sum of letter-number sequencing and digit span (total raw scores) will be used as secondary outcome measures.
Measured: 9-12 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- Helse Sor-Ost
- Responsible party
- Sponsor
- Investigators
- Gro CC Lohaugen, Phd, Principal investigator, Department of Child rehabilitation, Sørlandet Hospital, Arendal, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119364
- Sponsor's protocol ID
- 2012/2/00|14
- Status last verified
- Apr 2014
- First submitted
- 3 Apr 2013
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lohaugen GC, Beneventi H, Andersen GL, Sundberg C, Ostgard HF, Bakkan E, Walther G, Vik T, Skranes J. Do children with cerebral palsy benefit from computerized working memory training? Study protocol for a randomized controlled trial. Trials. 2014 Jul 7;15:269. doi: 10.1186/1745-6215-15-269.
PubMed 24998242
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 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 (CP)
- ClinicalTrials.gov ID
- NCT02119364
- Acronym / sponsor ID
- 2012/2/00|14
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, working memory, cognitive training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- Helse Sor-Ost
- Study start
- Oct 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 21 Apr 2014 (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.
Cerebral palsy (CP) is the most common motor disability in childhood (2-3 per 1000 live born), and is frequently accompanied by cognitive impairments and behavioural problems. The present study is a controlled clinical trial, a multicenter-study involving three health regions, as well as the Norwegian University of Science and Technology (NTNU). Its primary research goal will be to evaluate the effects of computer-based cognitive training in children with CP. In addition, this study will be the first to conduct a comprehensive neuropsychological examination to improve our understanding of cognitive impairments as well as cognitive resources in CP children in Norway to aid in intervention planning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Working memory training | Active comparator | Other: Working memory trainingAfter baseline assessment participants will be randomized to active training or treatment as usual (waiting). The active group will start training immediately and will have 6 weeks to perform the 25 training sessions. |
| Passive control group | No intervention | –The control group will receive "treatment as usual" (special education, physiotherapy etc). |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Cerebral Palsy
- School age (7-15 years of age)
Key exclusion criteria (1 listed)
- Not able to use computer, blind, deaf
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 |
|---|---|---|
| Working memory trainingAlso: Cogmed RoboMemoThe child will use the computer program at home under parental supervision for 25 sessions, each lasting 30-45 minutes and the family has 6 weeks to complete the training. Each session consists of 8 different tasks presented by an animated robot. The tasks all require the child to hold information in working memory and to manipulate the information. | Other | Working memory training |
Primary outcome
Spatial span
Time frame: 9-12 weeks after inclusion
The spatial span board from the Wechsler Memory scale 3ed. will represent our primary outcome measure. The total of forward and backward span will be used as primary outcome measure.
1 secondary outcome
Verbal working memory
Time frame: 9-12 weeks after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- Derived from this study: PubMed 24998242Lohaugen GC, Beneventi H, Andersen GL, Sundberg C, Ostgard HF, Bakkan E, Walther G, Vik T, Skranes J. Do children with cerebral palsy benefit from computerized working memory training? Study protocol for a randomized controlled trial. Trials. 2014 Jul 7;15:269. doi: 10.1186/1745-6215-15-269.
Related trials for Cerebral Palsy
Recruiting
Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation
Cerebral Palsy
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
RecruitingPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform
Progressive Supranuclear Palsy(PSP)
RecruitingObservational study
Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy
Cerebral Palsy Infantile
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
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.
Gro CC Lohaugen, Phd principal investigator
Department of Child rehabilitation, Sørlandet Hospital, Arendal, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Working memory training in people with Cerebral Palsy, run by Sorlandet Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 21 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gro CC Lohaugen, Phd (+47 95844805, gro.c.lohaugen@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial span (time frame: 9-12 weeks after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02119364, which also lists 1 linked publication.
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 21 Apr 2014.