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StrokeNCT02220816

Efficacy of an Attentional Process Training Using Competitive Versus Non Competitive Strategies

A study testing Competitive training and Non-Competitive Training in people with Stroke and Brain Injuries, run by Hospitales Nisa at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Within a prospective, randomised, controlled study 60, selected patients with chronic (> 6 months) stroke or traumatic brain injury will be randomised to 30 1-hour sessions of competitive versus non-competitive attentional training. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Stroke, Brain Injuries
What is being tested?
Competitive training and Non-Competitive Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSpain
Study dates
Oct 2014to Mar 2015
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Acquired brain injury patients (stroke and traumatic brain injury)
  • Chronicity > 6 months
  • More than 3 months under cognitive rehabilitation
  • Mississippi Aphasia Screening Test (comprehension subtest > 45)

Who cannot join

  • Severe cognitive impairment defined as < 23 on Mini Mental Status Examination
  • Unable to give informed consent
  • Visual or auditive disorders limiting the ability to comply with treatment regimen

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospitales NISA

    Valencia, Valencia, 46011

Other trials in Spain

About this study

Within a prospective, randomised, controlled study 60, selected patients with chronic (> 6 months) stroke or traumatic brain injury will be randomised to 30 1-hour sessions of competitive versus non-competitive attentional training. Competitive training will include fifteen 1-hour sessions of standard (paper and pencil) training under competitive situations and fifteen 1-hour sessions of competitive attentional games designed for this purpose using a new virtual reality system (conventional liquid-crystal-display screen with an infrared LED array to facilitate multi-touch experience embedded in a conventional table). Progress will be evaluated by pre and post measurement of attentional neuropsychological tests, subjective reports of global attention, usability and motivational scales. Our hypothesis is that competitive training is more effective in improving attention than conventional training in the chronic phase after acquired brain injury.

Read the detailed description

Participants: Sixty 18-75 years-old patients with acquired brain injury, will be randomly assigned to 30 sessions of competitive versus non-competitive cognitive attentional training (see inclusion-exclusion criteria). Material and Methods: Randomized clinical trial comparing two different attentional training strategies. Attentional measures, usability data and caregiver/family perception of change, will be compared after completing both conditions. Competitive training will include a new computer based training program that involve using attentional skills under different competitive scenarios. Attentional exercises were designed according to the instructions of two experts neuropsychologists and included game-based situations simulating different olympic disciplines.Neuropsychological protocol: An assessment before the beginning of the intervention and pos-treatment will be done by a trained blinded neuropsychologist using measures of selective, sustained, divided and alternating attention (see primary outcome measures). Usability and Motivation: It is well-known that game-based cognitive exercises can increase motivation to treatment which in turn can increase learning strategies and improve outcomes after rehabilitation processes. Competitive tasks can also improve the effort and interest of the players and the intensity of the task through increasing motivation to win, get a reward and beat the others. Since motivation was an important element of our research, we assessed this capacity at the end of the treatment with the Intrinsic Motivation Scale. Also, the revised Competitiveness Index was used to measure the subject's preference for competitive situations. Finally, usability was considered a secondary outcome of our study since most of the games employed here were designed to be played in a new virtual reality system which was build to facilitate competitive strategies among 2-4 players (see secondary outcomes). Sample Size Calculation: There was any previous study that used the design proposed in this investigation. Considering a reduction bigger of 20% on the Hit-Reaction Time of the CPT-II scores in the active group intervention, sample size in both groups of 27 participants and standard-deviation in the magnitude of half of the medium score in each group (moderate variability), the study will be able to detect a moderate effect size (ES = 0,4). Calculating a sample loss of 10% each group, we define a sample size per group of 30 individuals. Statistical methods Statistical analyses will be performed with Statistical Package for the Social Sciences (SPSS) 12.0. The univariate analyses will be performed with the t student test / Mann-Whitney to continuous variables or Chi-Square test (X²) / Fischer test to categorical variables. The effective of the intervention over time will be assess through analyses of mixed models (repeated measures ANOVA).

Being tested
Competitive training, Non-Competitive Training
Keywords
Attention, Competitive, Training
Medical subject headings
Stroke, Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Competitive trainingBehavioural

    30 sessions of competitive cognitive training; 3 - 5 sessions/week; duration 45 min

  • Non-Competitive TrainingBehavioural

    30 sessions of non-competitive cognitive training; 3 - 5 sessions/week; duration 45 min

Study groups in NCT02220816
Study groupRoleWhat they receive
Competitive TrainingExperimentalThe patients will receive only competitive activities designed to restore attention abilities. These include pencil-and-paper tasks completed under competitive circumstances and competitive virtual games specifically designed to treat different aspects of attention (divided, selective, sustained, etc).
Receives: Behavioral: Competitive training
Non-Competitive TrainingActive comparatorThe patients will receive conventional attentional training. Pencil and paper tasks focused on different aspects of attention (divided, selective, sustained, etc.) will be completed by all participant under individual or group-therapy sessions. No competitive training will be allowed.
Receives: Behavioral: Non-Competitive Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in attentional psychometric measures

    Neuropsychological battery: Conner's Continuous Performance Test (CPT-II), Color-Trail Test, d2, Stroop test, Wechsler Adult Intelligence Scale-IV digit-span, Corsi block-tapping test

    Measured: Baseline versus end of treatment (an expected average of 8 weeks)

Secondary outcomes (1)
  1. Usability measures

    System Usability Scale, Intrinsic Motivation Inventory

    Measured: Baseline versus end of treatment (an expected average of 8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

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
Single blind
Who is masked
Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02220816
Sponsor's protocol ID
NISA-COG-2014/1
Status last verified
Aug 2015
First submitted
18 Aug 2014
Last updated
19 Aug 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Competitive training and Non-Competitive Training in people with Stroke and Brain Injuries, run by Hospitales Nisa at 1 site in Spain.

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 4 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 19 Aug 2015. 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 Spain. 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?

Change in attentional psychometric measures (time frame: Baseline versus end of treatment (an expected average of 8 weeks)). 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 19 Aug 2015.

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