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StrokeNCT05524727

PEMOCS: Personalized Motor-cognitive Training in Chronic Stroke

A study testing Concept-guided, personalized, motor-cognitive training by means of an exergame in people with Stroke, run by University of Zurich at 3 sites in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In Switzerland, approximately 20'000 persons suffer a stroke each year. Despite carefully considered rehabilitation programs, full recovery is achieved only in a small proportion of stroke survivors (www.swissheart.ch). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Concept-guided, personalized, motor-cognitive training by means of an exergame
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
3 sitesSwitzerland
Study dates
1 Sep 2022to Jul 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults (> 18 years) with chronic stroke (≥ 6 months post-stroke)
  • Stroke: ischemic or haemorrhagic
  • Able to stand for 3 minutes and walk 10 meters, functional ambulation category ≥ 3
  • Able to follow a two-stage command
  • Able to give informed consent as documented by signature

Who cannot join

  • Unable or not willing to give informed consent
  • Other neurological diseases (e.g. Parkinson's Disease, multiple sclerosis), except cognitive deficits or dementia
  • Clinical contra-indications for the study intervention
  • Unable to follow the study intervention or the test for the primary endpoint (MoCA), e.g. due to a neglect, aphasia or other language problems
  • Overlapping enrolment in another clinical trial

Trial locations and contacts

3 sites in 1 country.

Switzerland3 sites

  • Kantonsspital Winterthur

    Winterthur, Canton of Zurich, 8400

  • Ambulante Reha Triemli Zürich

    Zurich, 8063

  • University Hospital Zürich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: PEMOCS: Effects of a Concept-guided, PErsonalized, MOtor-Cognitive Training in Chronic Stroke - a RCT

In Switzerland, approximately 20'000 persons suffer a stroke each year. Despite carefully considered rehabilitation programs, full recovery is achieved only in a small proportion of stroke survivors (www.swissheart.ch). Studies suggest that motor-cognitive trainings can improve gait, balance, and mobility in chronic stoke survivors. However, little is known about the effect of motor-cognitive trainings on cognitive functioning in chronic stroke.

The aim of this study is to evaluate the effects of a motor-cognitive training added to usual care compared to usual care alone on cognitive functions, single- and dual-task mobility, gait and health-related quality of life.

Read more

In this single-blind RCT, 38 participants will be allocated randomly to either the intervention group (usual care + motor-cognitive training by means of an exergame for 12 weeks, 2x/week for 30-40 minutes) or the control group (usual care only). Both groups will attend three assessments, at baseline, post-intervention (12 weeks after baseline), and at follow-up (24 weeks after baseline). Global cognitive functioning will be the primary endpoint and a linear mixed model will be used for analysis.

Motor-cognitive trainings, especially exergames, bear the potential for further development of innovative long-term rehabilitation solutions for chronic stroke survivors. Cognitive deficits are a common unmet need restricting daily activities mentioned by chronic stroke survivors. Exergame training following personally tailored progression to generate optimal training load may help addressing this unmet need. Therefore, this study will contribute to the on-going research objective on how to improve the long-term care of stroke patients.

Conditions
Stroke
Being tested
Concept-guided, personalized, motor-cognitive training by means of an exergame
Keywords
cognition, gait, mobility, training, chronic stroke, rehabilitation, virtual reality
Medical subject headings
Stroke

What participants receive

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

  • Concept-guided, personalized, motor-cognitive training by means of an exergameOther

    12 weeks, two times per week for 30-40min

Study groups in NCT05524727
Study groupRoleWhat they receive
Intervention GroupExperimentalUsual care + concept-guided, personalized, motor-cognitive training by means of an exergame
Receives: Other: Concept-guided, personalized, motor-cognitive training by means of an exergame
Control GroupNo interventionUsual care only

What is being measured

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

  1. Change of Montreal Cognitive Assessment Score

    Widely used screening tool and cognitive outcome in neurological patients including stroke

    Measured: week 0, week 12 and week 24

Secondary outcomes (9)

  1. Change of Stroke Impact Scale 3.0 Score

    Stroke-specific measurement tool assessing patient-reported health-related quality of life

    Measured: week 0, week 12 and week 24

  2. Change of Simple Reaction Test Parameters

    Widely used reliable and valid neuropsychological test assessing alertness

    Measured: week 0, week 12 and week 24

  3. Change of Trail Making Test A & B Parameters

    Widely used reliable and valid neuropsychological test assessing processing speed and executive functions

    Measured: week 0, week 12 and week 24

  4. Change of Stroop Interference Test Parameters

    Widely used reliable and valid neuropsychological test assessing the ability to inhibit the reaction to a more dominant stimulus in favour of the inquired reaction to a less dominant stimulus

    Measured: week 0, week 12 and week 24

  5. Change of N-back test Parameters

    Widely used reliable and valid neuropsychological test assessing working memory and related cognitive functions

    Measured: week 0, week 12 and week 24

  6. Change of Mental Rotation Test Parameters

    Measures the ability to mentally rotate abstract objects

    Measured: week 0, week 12 and week 24

  7. Change in Single- and cognitive Dual-Task Timed Up and Go Test Parameters and motor/cognitive dual task costs

    Widely used, reliable and valid test of mobility and dual-task ability in various populations including stroke.

    Measured: week 0, week 12 and week 24

  8. Change of 10 meter walk test Gait Parameters

    Widely used test to assess gait speed and spatiotemporal gait parameters.

    Measured: week 0, week 12 and week 24

  9. Change of Outdoor Gait Parameters

    Assesses walking endurance and spatiotemporal gait parameters under daily-life conditions.

    Measured: week 0, week 12 and week 24

Timeline

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

  1. First posted1 Sep 2022
  2. Study start1 Sep 2022
  3. Primary completionJul 2024 (estimated)
  4. Study completionJul 2024 (estimated)

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
Model description
RCT
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05524727
Sponsor's protocol ID
2022-0614
Status last verified
Jan 2024
First submitted
2 Aug 2022
Last updated
18 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Huber SK, Knols RH, Held JPO, Betschart M, Gartmann S, Nauer N, de Bruin ED. PEMOCS: effects of a concept-guided, PErsonalized, MOtor-Cognitive exergame training on cognitive functions and gait in chronic Stroke-a randomized, controlled trial. Front Aging Neurosci. 2025 Mar 13;17:1514594. doi: 10.3389/fnagi.2025.1514594. eCollection 2025.

    PubMed 40182756

  • Huber SK, Knols RH, Held JPO, Betschart M, de Bruin ED. PEMOCS: Evaluating the effects of a concept-guided, PErsonalised, MOtor-Cognitive exergame training on cognitive functions and gait in chronic Stroke-study protocol for a randomised controlled trial. Trials. 2024 Jul 4;25(1):451. doi: 10.1186/s13063-024-08283-7.

    PubMed 38965612

Questions about this trial

What is this clinical trial studying?

A study testing Concept-guided, personalized, motor-cognitive training by means of an exergame in people with Stroke, run by University of Zurich at 3 sites in Switzerland.

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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Switzerland. 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?

Results are not available in the source record.

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 of Montreal Cognitive Assessment Score (time frame: week 0, week 12 and week 24). 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 NCT05524727, which also lists 2 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 18 Jan 2024.

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