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AzTrials

Cognition DisordersSANaRNCT02816008

Smart Autonomous Neuro-Rehabilitation System

A study testing Cognitive rehabilitation training with RGS in the clinic and Passive/conventional cognitive training at home. in people with Cognition Disorders and Cognitive Deficits, run by Universitat Pompeu Fabra.

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

Cognitive rehabilitation is defined as a systematic functionally oriented intervention of therapeutic cognitive activities based on the assessment and understanding of patient's brain behavior deficits. Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Cognition Disorders, Cognitive Deficits
What is being tested?
Cognitive rehabilitation training with RGS in the clinic and Passive/conventional cognitive training at home.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
No sites listed yet
Study dates
Jul 2016to Feb 2018
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 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Score on Mini-Mental State Examination between 18 - 24
  • Score on Montreal Cognitive Assessment less than 26
  • More than 2 points in upper limb motor scale MRC
  • Sufficient cognitive ability to understand and follow the experimental instructions

Who cannot join

  • Score on Mini-Mental State Examination below 18 or above 24
  • Score on Montreal Cognitive Assessment of 26 or above
  • Below 2 point in upper limb motor scale MRC
  • Hemianopia
  • Cognitive capacity that prohibits the execution of the experiment
  • Severe impairment like spasticity, aphasia or apraxia, major pain or other neuromuscular impairments or dependent on use of orthopedic devices that would interfere with the correct execution of understanding of the experiment
  • History of serious mental-health problems in acute or subacute phase
  • Patients that do not give their consent to participate in the study

About this study

Cognitive rehabilitation is defined as a systematic functionally oriented intervention of therapeutic cognitive activities based on the assessment and understanding of patient's brain behavior deficits. This project focuses on restoring cognitive functions in order to understand the underlying deficits in the patient's brain by developing integrated cognitive rehabilitation scenarios in virtual reality that combine memory, attention and problem solving training with context specific motor movements.

Being tested
Cognitive rehabilitation training with RGS in the clinic, Passive/conventional cognitive training at home.
Keywords
cognitive rehabilitation, memory, attention, spatial neglect, executive dysfunctioning
Medical subject headings
Cognition Disorders

What participants receive

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

  • Cognitive rehabilitation training with RGS in the clinicBehavioural

    Daily cognitive training with the Rehabilitation Gaming System (RGS) in the clinic during 6 weeks (5 days per week a 30 minutes).

  • Passive/conventional cognitive training at home.Behavioural

    Daily conventional cognitive rehabilitation at home as recommended by the neurologist during 6 weeks (5 days per week a 30 minutes).

Study groups in NCT02816008
Study groupRoleWhat they receive
Cognitive rehabilitation groupExperimentalCognitive rehabilitation training with RGS in the clinic.
Receives: Behavioral: Cognitive rehabilitation training with RGS in the clinic
Passive control groupActive comparatorPassive/conventional cognitive training at home.
Receives: Behavioral: Passive/conventional cognitive training at home.

What is being measured

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

  1. Change in Digit Span Forward WAIS-IV from baseline to end of treatment and to follow-up

    Measurement of attention

    Measured: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)

  2. Change in Corsi block tapping test from baseline to end of treatment and to follow-up

    Measurement of attention

    Measured: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)

  3. Change in Trail Making Test, Part A from baseline to end of treatment and to follow-up

    Measurement of attention

    Measured: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)

  4. Change in Rey Auditory Verbal Learning Test from baseline to end of treatment and to follow-up

    Measurement of episodic memory

    Measured: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)

  5. Change in Digit Span Backward WAIS-IV from baseline to end of treatment and to follow-up

    Measurement of working memory

    Measured: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)

  6. Change in Corsi block-tapping test reversed from baseline to end of treatment and to follow-up

    Measurement of working memory

    Measured: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)

  7. Change in Frontal Assessment Battery from baseline to end of treatment and to follow-up

    Measurement of executive functioning

    Measured: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)

  8. Change in Trail Making Test, Part B from baseline to end of treatment and to follow-up

    Measurement of set-shifting

    Measured: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)

  9. Change in Digit Symbol Coding in WAIS-IV from baseline to end of treatment and to follow-up

    Measurement of processing speed

    Measured: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)

  10. Change in Star Cancellation test from baseline to end of treatment and to follow-up

    Measurement of spatial neglect

    Measured: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)

Secondary outcomes (4)

  1. Change in Montreal Cognitive Assessment from baseline to end of treatment and to follow-up

    Measurement of global cognitive ability

    Measured: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)

  2. Change in Mini-Mental State Examination from baseline to end of treatment and to follow-up

    Measurement of global health status

    Measured: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)

  3. Change in Barthel Index from baseline to end of treatment and to follow-up

    Measurement of independent functioning and mobility in activities of daily living

    Measured: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)

  4. Change in Fugl-Meyer Assessment from baseline to end of treatment and to follow-up

    Measurement of motor recovery after stroke

    Measured: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)

Timeline

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

  1. First posted28 Jun 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionFeb 2018
  4. Study completionFeb 2018

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
Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02816008
Sponsor's protocol ID
SANaR
Acronym
SANaR
Status last verified
May 2018
First submitted
21 Jun 2016
Last updated
23 May 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, 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 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015.

    PubMed 21440699

  • Ball K, Berch DB, Helmers KF, Jobe JB, Leveck MD, Marsiske M, Morris JN, Rebok GW, Smith DM, Tennstedt SL, Unverzagt FW, Willis SL; Advanced Cognitive Training for Independent and Vital Elderly Study Group. Effects of cognitive training interventions with older adults: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2271-81. doi: 10.1001/jama.288.18.2271.

    PubMed 12425704

  • Corbetta M, Ramsey L, Callejas A, Baldassarre A, Hacker CD, Siegel JS, Astafiev SV, Rengachary J, Zinn K, Lang CE, Connor LT, Fucetola R, Strube M, Carter AR, Shulman GL. Common behavioral clusters and subcortical anatomy in stroke. Neuron. 2015 Mar 4;85(5):927-41. doi: 10.1016/j.neuron.2015.02.027.

    PubMed 25741721

  • Nair RD, Lincoln NB. Cognitive rehabilitation for memory deficits following stroke. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD002293. doi: 10.1002/14651858.CD002293.pub2.

    PubMed 17636703

  • Maier M, Ballester BR, Leiva Banuelos N, Duarte Oller E, Verschure PFMJ. Adaptive conjunctive cognitive training (ACCT) in virtual reality for chronic stroke patients: a randomized controlled pilot trial. J Neuroeng Rehabil. 2020 Mar 6;17(1):42. doi: 10.1186/s12984-020-0652-3.

    PubMed 32143674

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive rehabilitation training with RGS in the clinic and Passive/conventional cognitive training at home. in people with Cognition Disorders and Cognitive Deficits, run by Universitat Pompeu Fabra.

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 8 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 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.

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 Digit Span Forward WAIS-IV from baseline to end of treatment and to follow-up (time frame: Measured at baseline, at 6 weeks (end of treatment), and at 3-months (follow-up)). The study lists 10 primary outcomes in all. 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 NCT02816008, which also lists 5 linked publications.

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 23 May 2018.

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