Computerized Cognitive Rehabilitation of Executive Deficits in Stroke Patients

NCT05169632 | Recruiting DMC

• 1 other identifier: CHUV-DNC-CCT-STROKE-2021
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

WHO: 32 participants with executive deficits related to a stroke, able to engage in moderate physical activity. WHY: Around one third of stroke patients suffer from cognitive deficits in the long term, which have a detrimental impact on everyday personal and professional life. The purpose of this study is to evaluate two sets of computerized exercises combining cognitive and physical effort to see if they can improve executive function. WHAT: Study participants first undergo cognitive and physical assessments. Additional questionnaires will assess mood, everyday life cognition, function and quality. This will be followed by a 6 week training period with 3 training sessions a week. The effect of the cognitive and physical training will be measured in a post-training evaluation session. Six months after completion of the training, the study will evaluate cognitive and physical abilities of participants to study long-term effects of the respective training program. WHERE: Both the evaluation and the training sessions will be conducted on the premises of the Centre Hospitalier Universitaire Vaudoise (Pavillon 4, Avenue de Beaumont, 1005 Lausanne, Switzerland)

Conditions

Stroke; Executive Dysfunction

Keywords

Stroke Rehabilitation; Neurological Rehabilitation; Exercise Therapy; Brain Training; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Mental Disorders; Vascular System Injuries; Cerebrovascular Disorders; Multimodal Intervention; e-Health; Digital Intervention; Exergame

Outcome Measures

Primary Outcomes (4)

• Change in cognitive interference after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)

  Cognitive interference is measured using the Delis-Kaplan Executive Function System (D-KEFS; Delis, Kaplan, Kramer, 2001) Stroop Test

  6 weeks

• Change in divided attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)

  Divided attention is measured using the Test of Attentional Performance (TAP, version 2.3.1; Zimmermann and Fimm, 2002) subtest for divided attention

  6 weeks

• Change in visuospatial short term memory after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)

  Visuospatial short term memory is measured by the immediate recall of the Brief Visuospatial Memory Test-Revised (BVMT-R; Benedict, 1996)

  6 weeks

• Change in subjective executive function after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)

  Subjective executive function is measured by the Working Memory Questionnaire (WMQ; Vallat-Azouvi et al, 2012; 30 items, participants rate 10 statements on storage, attention and executive domain on a Likert-scale from 1-5 (not at all - extremely))

  6 weeks

Secondary Outcomes (21)

• Change in visual working memory after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)

  6 weeks

• Change in design fluency after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)

  6 weeks

• Change in processing speed after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)

  6 weeks

• Change in cognitive flexibility assessed by the TMT-B after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)

  6 weeks

• Change in cognitive flexibility assessed by the TAP Flexibility after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2)

  6 weeks

Other Outcomes (2)

• Subjective experience with technology used in study

  6 weeks

• Perception of game training

  6 weeks

Study Arms (2)

Control group (CTR)

ACTIVE COMPARATOR

Computerized Gaming Rehabilitation Program 1

Device: Computerized Gaming Rehabilitation Program 1

Intervention group (INT)

EXPERIMENTAL

Computerized Gaming Rehabilitation Program 2

Device: Computerized Gaming Rehabilitation Program 2

Interventions

Computerized Gaming Rehabilitation Program 1 DEVICE

Brain training games with physical exercise component.

Control group (CTR)

Computerized Gaming Rehabilitation Program 2 DEVICE

Cognitive training games with physical exercise component.

Intervention group (INT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Cognitive complaint and/or clinical impression of dysexecutive syndrome
• Z-Score \< -1.0 in at least two of the following domains
• Cognitive flexibility (Trail-Making Test B/A)
• Cognitive interference (Stroop color word interference task)
• Divided attention (TAP divided attention)
• Working memory (TAP working memory, Forward Digit Span, Backward Digit Span)
• Design fluency (Five-points test)

You may not qualify if:

• Major neurocognitive disorder according to the DSM-5
• Proximal extremity paresis grade \< M4 on the Medical Research Council (MRC) Scale for Muscle Strength in at least one of four extremities
• Insufficient visual acuity, visual field or hemispatial attention to engage in the training
• Inability to discriminate colour: \< 12 points on the Ishihara test
• Changes over the last 4 weeks in antidepressive, anxiolytic or in acetylcholinesterase inhibitor drugs
• Thoracic pain and/or heart palpitations at rest, during or following a physical effort (based on self-report)
• Clinically unstable cardio-vascular disease
• Falls in the past 12 weeks as evaluated in the enrolment interview \[Hopkins Falls Grading Scale (Grade \>1)\]
• High risk of falling according to a score of over 15 seconds on the Four Square Step Test (FSST)
• Insufficient knowledge or capacity of French to follow instructions
• Incapacity or unwillingness to provide informed consent

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Lausanne University Hospital (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (17)

• Zimmermann, P. and B. Fimm, A test battery for attentional performance. Applied Neuropsychology of Attention, Theory, Diagnosis and Rehabilitation 2002: p. 110-151.

  BACKGROUND

• Benedict, R.H.B., et al., Revision of the Brief Visuospatial Memory Test: Studies of normal performance, reliability, and Validity. Psychological Assessment, 1996.

  BACKGROUND

• Delis DC, Kramer JH, Kaplan E, Holdnack J. Reliability and validity of the Delis-Kaplan Executive Function System: an update. J Int Neuropsychol Soc. 2004 Mar;10(2):301-3. doi: 10.1017/S1355617704102191. No abstract available.

  PMID: 15012851 BACKGROUND

• Vallat-Azouvi C, Pradat-Diehl P, Azouvi P. The Working Memory Questionnaire: a scale to assess everyday life problems related to deficits of working memory in brain injured patients. Neuropsychol Rehabil. 2012;22(4):634-49. doi: 10.1080/09602011.2012.681110. Epub 2012 Apr 27.

  PMID: 22537095 BACKGROUND

• Vogel EK, McCollough AW, Machizawa MG. Neural measures reveal individual differences in controlling access to working memory. Nature. 2005 Nov 24;438(7067):500-3. doi: 10.1038/nature04171.

  PMID: 16306992 BACKGROUND

• Regard M, Strauss E, Knapp P. Children's production on verbal and non-verbal fluency tasks. Percept Mot Skills. 1982 Dec;55(3 Pt 1):839-44. doi: 10.2466/pms.1982.55.3.839. No abstract available.

  PMID: 7162920 BACKGROUND

• REITAN RM. The relation of the trail making test to organic brain damage. J Consult Psychol. 1955 Oct;19(5):393-4. doi: 10.1037/h0044509. No abstract available.

  PMID: 13263471 BACKGROUND

• Dite W, Temple VA. A clinical test of stepping and change of direction to identify multiple falling older adults. Arch Phys Med Rehabil. 2002 Nov;83(11):1566-71. doi: 10.1053/apmr.2002.35469.

  PMID: 12422327 BACKGROUND

• Franchignoni F, Horak F, Godi M, Nardone A, Giordano A. Using psychometric techniques to improve the Balance Evaluation Systems Test: the mini-BESTest. J Rehabil Med. 2010 Apr;42(4):323-31. doi: 10.2340/16501977-0537.

  PMID: 20461334 BACKGROUND

• von Steinbuchel N, Wilson L, Gibbons H, Hawthorne G, Hofer S, Schmidt S, Bullinger M, Maas A, Neugebauer E, Powell J, von Wild K, Zitnay G, Bakx W, Christensen AL, Koskinen S, Formisano R, Saarajuri J, Sasse N, Truelle JL; QOLIBRI Task Force. Quality of Life after Brain Injury (QOLIBRI): scale validity and correlates of quality of life. J Neurotrauma. 2010 Jul;27(7):1157-65. doi: 10.1089/neu.2009.1077.

  PMID: 20210602 BACKGROUND

• Broadbent DE, Cooper PF, FitzGerald P, Parkes KR. The Cognitive Failures Questionnaire (CFQ) and its correlates. Br J Clin Psychol. 1982 Feb;21(1):1-16. doi: 10.1111/j.2044-8260.1982.tb01421.x.

  PMID: 7126941 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Radakovic R, Abrahams S. Developing a new apathy measurement scale: Dimensional Apathy Scale. Psychiatry Res. 2014 Nov 30;219(3):658-63. doi: 10.1016/j.psychres.2014.06.010. Epub 2014 Jun 19.

  PMID: 24972546 BACKGROUND

• Larson RD. Psychometric properties of the modified fatigue impact scale. Int J MS Care. 2013 Spring;15(1):15-20. doi: 10.7224/1537-2073.2012-019.

  PMID: 24453758 BACKGROUND

• Tinetti ME, Richman D, Powell L. Falls efficacy as a measure of fear of falling. J Gerontol. 1990 Nov;45(6):P239-43. doi: 10.1093/geronj/45.6.p239.

  PMID: 2229948 BACKGROUND

• Brooke, J., SUS: A 'Quick and Dirty' Usability Scale. 1996.

  BACKGROUND

• Boot WR, Champion M, Blakely DP, Wright T, Souders DJ, Charness N. Video games as a means to reduce age-related cognitive decline: attitudes, compliance, and effectiveness. Front Psychol. 2013 Feb 1;4:31. doi: 10.3389/fpsyg.2013.00031. eCollection 2013.

  PMID: 23378841 BACKGROUND

MeSH Terms

Conditions

Stroke; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Mental Disorders; Vascular System Injuries; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries

Study Officials

• Arseny A. Sokolov, Prof MD PhD

  Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland

  PRINCIPAL INVESTIGATOR

• Giulia Binarelli, PhD

  Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland

  STUDY CHAIR

Central Study Contacts

Giulia Binarelli, PhD

CONTACT

+41 21 314 25 42; giulia.binarelli@chuv.ch

Arseny A. Sokolov, Prof MD PhD

CONTACT

+41 79 556 73 55; arseny.sokolov@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: December 27, 2021
• Study Start: March 17, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)