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PEMOCS: Personalized Motor-cognitive Training in Chronic Stroke

University of Zurich (UZH) logo

University of Zurich (UZH)

Status

Active, not recruiting

Conditions

Stroke

Treatments

Other: Concept-guided, personalized, motor-cognitive training by means of an exergame

Study type

Interventional

Funder types

Other

Identifiers

NCT05524727
2022-0614

Details and patient eligibility

About

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.

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.

Enrollment

38 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

38 participants in 2 patient groups

Intervention Group
Experimental group
Description:
Usual care + concept-guided, personalized, motor-cognitive training by means of an exergame
Treatment:
Other: Concept-guided, personalized, motor-cognitive training by means of an exergame
Control Group
No Intervention group
Description:
Usual care only

Trial contacts and locations

3

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Central trial contact

Rudolf Knols, PhD; Simone Huber, MSc

Data sourced from clinicaltrials.gov

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