PEMOCS: Personalized Motor-cognitive Training in Chronic Stroke

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Concept-guided, personalized, motor-cognitive training by means of an exergame

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich
  • Zurich, Switzerland, 8063
    • Ambulante Reha Triemli Zürich
  • Zurich
    • Winterthur, Zurich, Switzerland, 8400
      • Kantonsspital Winterthur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Usual care + concept-guided, personalized, motor-cognitive training by means of an exergame	Other: Concept-guided, personalized, motor-cognitive training by means of an exergame; 12 weeks, two times per week for 30-40min
No Intervention: Control Group; Usual care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Montreal Cognitive Assessment Score	Widely used screening tool and cognitive outcome in neurological patients including stroke	week 0, week 12 and week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Stroke Impact Scale 3.0 Score	Stroke-specific measurement tool assessing patient-reported health-related quality of life	week 0, week 12 and week 24
Change of Simple Reaction Test Parameters	Widely used reliable and valid neuropsychological test assessing alertness	week 0, week 12 and week 24
Change of Trail Making Test A & B Parameters	Widely used reliable and valid neuropsychological test assessing processing speed and executive functions	week 0, week 12 and week 24
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	week 0, week 12 and week 24
Change of N-back test Parameters	Widely used reliable and valid neuropsychological test assessing working memory and related cognitive functions	week 0, week 12 and week 24
Change of Mental Rotation Test Parameters	Measures the ability to mentally rotate abstract objects	week 0, week 12 and week 24
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.	week 0, week 12 and week 24
Change of 10 meter walk test Gait Parameters	Widely used test to assess gait speed and spatiotemporal gait parameters.	week 0, week 12 and week 24
Change of Outdoor Gait Parameters	Assesses walking endurance and spatiotemporal gait parameters under daily-life conditions.	week 0, week 12 and week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance Rate	attended sessions / offered sessions	week 12
Adherence Rate	attended training time / offered training time	week 12
Perceived Motor-Cognitive Task Difficulty	visual analogue scale after each training session, based on cognitive load theory, scale from 1-9, where 9 symbolizes most difficult	twice per week, week 0-12
Perceived Performance	visual analogue scale after each training session, performance item of the National Aeronautics and Space Administration - Task Load Index, scale from 0 to 20, where 20 symbolizes highest performance	twice per week, week 0-12
Dose and Content of Usual Care	according to weekly questionnaire, based on TIDIeR checklist	once per week, week 0-24
Amount and Intensity of General Physical and Cognitive Activity	according to weekly questionnaire, based on TIDIeR checklist	once per week, week 0-24

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: gait; rehabilitation; cognition; mobility; virtual reality; training; chronic stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2022-0614

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No