PEMOCS: Personalized Motor-cognitive Training in Chronic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Group

Usual care + concept-guided, personalized, motor-cognitive training by means of an exergame

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Control Group

Usual care only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No