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

Primary Purpose

Stroke, Brain Injuries

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Competitive training
Non-Competitive Training
Sponsored by
Hospitales Nisa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Attention, Competitive, Training

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Hospitales NISA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Competitive Training

Non-Competitive Training

Arm Description

The 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).

The 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Usability measures
System Usability Scale, Intrinsic Motivation Inventory

Full Information

First Posted
August 18, 2014
Last Updated
August 18, 2015
Sponsor
Hospitales Nisa
Collaborators
Universitat Politècnica de València, University of Seville
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1. Study Identification

Unique Protocol Identification Number
NCT02220816
Brief Title
Efficacy of an Attentional Process Training Using Competitive Versus Non Competitive Strategies
Official Title
Efficacy of an Attentional Process Training Using Competitive Versus Non Competitive Strategies
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospitales Nisa
Collaborators
Universitat Politècnica de València, University of Seville

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Brain Injuries
Keywords
Attention, Competitive, Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Competitive Training
Arm Type
Experimental
Arm Description
The 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).
Arm Title
Non-Competitive Training
Arm Type
Active Comparator
Arm Description
The 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.
Intervention Type
Behavioral
Intervention Name(s)
Competitive training
Intervention Description
30 sessions of competitive cognitive training; 3 - 5 sessions/week; duration 45 min
Intervention Type
Behavioral
Intervention Name(s)
Non-Competitive Training
Intervention Description
30 sessions of non-competitive cognitive training; 3 - 5 sessions/week; duration 45 min
Primary Outcome Measure Information:
Title
Change in attentional psychometric measures
Description
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
Time Frame
Baseline versus end of treatment (an expected average of 8 weeks)
Secondary Outcome Measure Information:
Title
Usability measures
Description
System Usability Scale, Intrinsic Motivation Inventory
Time Frame
Baseline versus end of treatment (an expected average of 8 weeks)
Other Pre-specified Outcome Measures:
Title
Family-centered outcomes
Description
Moos Attention Rating Scale, Subjective perception of improvement
Time Frame
Baseline versus end of treatment (an expected average of 8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Llorens, PhD
Organizational Affiliation
Universitat Politècnica de València
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospitales NISA
City
Valencia
ZIP/Postal Code
46011
Country
Spain

12. IPD Sharing Statement

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

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