Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

A customized home-based computerized cognitive rehabilitation platform for patients with chronic-stage stroke: study protocol for a randomized controlled trial

Authors: Macarena Gil-Pagés, Javier Solana, Rocío Sánchez-Carrión, Jose M. Tormos, Antonia Enseñat-Cantallops, Alberto García-Molina

Published in: Trials | Issue 1/2018

Login to get access

Abstract

Background

Stroke patients usually suffer primary cognitive impairment related to attention, memory, and executive functions. This impairment causes a negative impact on the quality of life of patients and their families, and may be long term. Cognitive rehabilitation has been shown to be an effective way to treat cognitive impairment and should be continued after hospital discharge. Computerized cognitive rehabilitation can be performed at home using exercise programs that advance with predetermined course content, interval, and pace. We hypothesize that computerized rehabilitation might be improved if a program could customize course content and pace in response to patient-specific progress. The present pilot study is a randomized controlled double-blind crossover clinical trial aiming to study if chronic stroke patients with cognitive impairment could benefit from cognitive training through a customized tele-rehabilitation platform (“Guttmann, NeuroPersonalTrainer”®, GNPT®).

Methods/design

Individuals with chronic-stage stroke will be recruited. Participants will be randomized to receive experimental intervention (customized tele-rehabilitation platform, GNPT®) or sham intervention (ictus.online), both with the same frequency and duration (five sessions per week over 6 weeks). After a washout period of 3 months, crossover will occur and participants from the GNPT® condition will receive sham intervention, while participants originally from the sham intervention will receive GNPT®. Patients will be assessed before and after receiving each treatment regimen with an exhaustive neuropsychological battery. Primary outcomes will include rating measures that assess attention difficulties, memory failures, and executive dysfunction for daily activities, as well as performance-based measures of attention, memory, and executive functions.

Discussion

Customized cognitive training could lead to better cognitive function in patients with chronic-stage stroke and improve their quality of life.

Trial registration

NCT03326349. Registered 31 October 2017.
Appendix
Available only for authorised users
Literature
1.
Donaghy M. Brain’s Diseases of the Nervous System. 12th ed. New York: Oxford University Press; 2009.
2.
Lezak MD, Howieson DB, Bigler ED, Tranel D. Neuropsychological Assessment. 5th ed. New York: Oxford University Press; 2012.
3.
Sacco R, Kasner S, Broderick J, Caplan L, Connors J, Culebras A, Elkind M, George M, Hamdan A, Higashida R, Hoh B, Janis L, Kase C, Kleindorfer D, Lee J, Moseley M, Peterson E, Turan T, Valderrama A, Vinters H. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013;44:2064–89.CrossRefPubMed
4.
Krishnamurthi R, Moran AE, Feigin VL, Barker-Collo S, Norrving B, Mensah GA, Taylor S, Naghavi M, Forouzanfar MH, Nguyen G, Johnson CO, Vos T, Murray CJ, Roth GA. Stroke prevalence, mortality and disability-adjusted life years in adults aged 20-64 years in 1990-2013: Data from the Global Burden of Disease 2013 Study. Neuroepidemiology. 2015;45(3):190–202. https://​doi.​org/​10.​1159/​000441098 CrossRefPubMed
5.
6.
Brea A, Laclaustra M, Martorell E, Pedragosa À. Epidemiology of cerebrovascular disease in Spain. Clínica e Investigación en Arteriosclerosis. 2013;25(Suppl 5):211–7.CrossRefPubMed
7.
8.
Ma VY, Chan L, Carruthers KJ. Incidence, prevalence, costs and impact on disability of common conditions requiring rehabilitation in the United States: stroke, spinal cord injury, traumatic brain injury, multiple sclerosis, osteoarthritis, rheumatoid arthritis, limb loss and back pain. Arch Phys Med Rehabil. 2014;95:986–95.CrossRefPubMedPubMedCentral
9.
Prokopenko S, Mozheyko E, Petrova M, Koryagina T, Kaskaeva D, Chernykh T, Shvetzova I, Bezdenezhnih A. Correction of post-stroke cognitive impairments using computer programs. J Neurol Sci. 2013;325:148–53.CrossRefPubMed
10.
11.
Bogdanova Y, Yee M, Ho V, Cicerone K. Computerized cognitive rehabilitation of attention and executive function in acquired brain injury. J Head Trauma Rehabil. 2016;31:419–33.CrossRefPubMedPubMedCentral
12.
Poulin V, Korner-Bitensky N, Dawson D, Bherer L. Efficacy of executive function interventions after stroke: a systematic review. Top Stroke Rehabil. 2012;19:158–71.CrossRefPubMed
13.
Solana J, Cáceres C, García-Molina A, Chausa P, Opisso E, Roig-Rovira T, Ernestina M, Tormos-Muñoz JM, Gómez EJ. Intelligent Therapy Assistant (ITA) for cognitive rehabilitation in patients with acquired brain injury. BMC Med Inform Decis Mak. 2014;14:58.CrossRefPubMedPubMedCentral
14.
Solana J, Cáceres C, García-Molina A, Opisso E, Roig T, Tormos JM, Gómez EJ. Improving brain injury cognitive rehabilitation by personalized telerehabilitation services: Guttmann Neuropersonal Trainer. IEEE J Biomed Health Inf. 2015;19(1):124–31.CrossRef
15.
16.
Toglia JP. Generalization of treatment: a multicontext approach to cognitive perceptual impairment in adults with brain injury. Am J Occup Ther. 1991;45(6):506–16.CrossRef
17.
Barnett SM, Cecci SJ. When and where do we apply what we learn? A taxonomy for transfer. Psychol Bull. 2002;128(4):612–37.CrossRefPubMed
18.
Van de Ven RM, Murre MJ, Veltman DJ, Schmand BA. Computer-based cognitive training for executive functions after stroke: a systematic review. Front Hum Neurosci. 2016;10:150.CrossRefPubMedPubMedCentral
19.
Cicerone K, Langenbahn D, Braden C, Malec J, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley J, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011;92:519–30.CrossRefPubMed
20.
21.
Whitehead A, Julious S, Cooper C, Campbell M. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2015;25:1057–73.CrossRefPubMedPubMedCentral
22.
De Luca R, Calabrò R, Gervasi G, De Salvo S, Bonanno L, Corallo F, De Cola M, Bramanti P. Is computer-assisted training effective in improving rehabilitative outcomes after brain injury? A case-control hospital-based study. Disabil Health J. 2014;7:356–60.CrossRefPubMed
23.
Westerberg H, Jacobaeus H, Hirvikoski T, Clevberger P, Östensson M, Bartfai A, Klingberg T. Computerized working memory training after stroke – A pilot study. Brain Inj. 2007;21:21–9.CrossRefPubMed
24.
Björkdahl A, Åkerlund E, Svensson S, Esbjörnsson E. A randomized study of computerized working memory training and effects on functioning in everyday life for patients with brain injury. Brain Inj. 2013;27:1658–65.CrossRefPubMed
25.
Peña-Casanova J. Normalidad, Semiología y Patología Neuropsicológicas. Programa Integrado de Exploración Neuropsicológica. Test Barcelona Revisado. 2nd ed. Barcelona: Masson; 2005.
26.
World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191–4.CrossRef
27.
Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin J, Doré C, Parulekar W, Summerskill W, Groves T, Schulz K, Sox H, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.CrossRefPubMedPubMedCentral
28.
Conners CK. Conners’ Continuous Performance Test II: Computer Program for Windows Technical Guide and Software Manual. North Tonwanda: Mutli-Health Systems; 2000.
29.
Tombaugh T. Trail Making Test A and B: Normative data stratified by age and education. Arch Clin Neuropsychol. 2004;19(2):203–14. https://​doi.​org/​10.​1016/​s0887-6177(03)00039CrossRefPubMed
30.
Wechsler D. WAIS-III. Administration and Scoring Manual. San Antonio: The Psychological Association; 1997.
31.
Schmid M. Rey Auditory and Verbal Learning Test: A Handbook. Los Angeles: Western Psychological Services; 1996.
32.
Golden CJ. Test of Colors and Words. Madrid: Tea Editions; 2001.
33.
Roig-Fusté JM. Prueba de clasificación de cartas. Barcelona: MTR; 2001.
34.
Artiola i Fortuny L, Hermosillo Romo D, Heaton RK, Pardee RE III. Manual de Normas y Procedimientos para la Batería Neuropsicológica en Español. Tucson: mPress; 1999.
35.
Ponsford J, Kinsella G. The use of a rating scale of attentional behavior. Neuropsychol Rehabil. 1991;1(4):241–57.CrossRef
36.
Crawford JR, Smith G, Maylor EA, Della Sala S, Logie RH. The Prospective and Retrospective Memory Questionnaire (PRMQ): normative data and latent structure in a large non-clinical sample. Memory. 2003;11(3):261–75.CrossRefPubMed
37.
Roth RM, Isquith PK, Goia GA. BRIEF-A: Behavior Rating Inventory of Executive Function – Adult version. Lutz: Psychological Assessment Resources, Inc.; 2005.
38.
Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983;67:361–70.CrossRefPubMed
39.
Prigatano GP, Fordyce DJ, Zeiner HK, Roueche JR, Pepping M, Wood BC. Neuropsychological Rehabilitation after Brain Injury. Baltimore: Johns Hopkins University Press; 1986.
40.
Willer B, Rosenthal M, Kreutzer JS, Gordon WA, Rempel R. Assessment of community integration following rehabilitation for traumatic brain injury. J Head Trauma Rehabil. 1993;8(2):75–87.CrossRef
41.
Fischer S, Trexler LE, Gauggel S. Awareness of activity limitations and prediction of performance in patients with brain injuries and orthopedic disorders. J Int Neuropsychol Soc. 2004;10(2):190–9.CrossRefPubMed
42.
Gauggel S, Peleska B, Bode RK. Relationship between cognitive impairments and rated activity restrictions in stroke patients. J Head Trauma Rehabil. 2000;15(1):710–23.CrossRefPubMed
43.
44.
Habeck C, Razlighi Q, Gazes Y, Barulli D, Steffener J, Stern Y. Cognitive reserve and brain maintenance: orthogonal concepts in theory and practice. Cereb Cortex. 2017;27:3962–9.PubMed
45.
Steward K, Kennedy R, Novack T, Crowe M, Marson D, Triebel K. The role of cognitive reserve in recovery from traumatic brain injury. J Head Trauma Rehabil. 2018;33(1):E18–27.PubMed
46.
Metadata
Title
A customized home-based computerized cognitive rehabilitation platform for patients with chronic-stage stroke: study protocol for a randomized controlled trial
Authors
Macarena Gil-Pagés
Javier Solana
Rocío Sánchez-Carrión
Jose M. Tormos
Antonia Enseñat-Cantallops
Alberto García-Molina
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2577-8

Other articles of this Issue 1/2018

Trials 1/2018 Go to the issue

Study protocol

A randomised pragmatic trial of corticosteroid optimization in severe asthma using a composite biomarker algorithm to adjust corticosteroid dose versus standard care: study protocol for a randomised trial

Study protocol

PATCH: posture and mobility training for care staff versus usual care in care homes: study protocol for a randomised controlled trial

Update

Statistical analysis plan for the Healthy Hands Project; single centre cluster-randomised clinical trial of a skin care program for the prevention of contact dermatitis in health care workers

Research

Patients’ reasoning regarding the decision to participate in clinical cancer trials: an interview study

Study protocol

High-flow nasal oxygen vs. standard oxygen therapy in immunocompromised patients with acute respiratory failure: study protocol for a randomized controlled trial

Study protocol

Comparison of cold and hot snaring polypectomy for small colorectal polyps: study protocol for a randomized controlled trial