PEMOCS: Personalized Motor-cognitive Training in Chronic Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05524727
• Other study ID #: 2022-0614
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: July 2024

Study information

• Verified date: January 2024
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Concept-guided, personalized, motor-cognitive training by means of an exergame
12 weeks, two times per week for 30-40min

Locations

Country	Name	City	State
Switzerland	Kantonsspital Winterthur	Winterthur	Zurich
Switzerland	Ambulante Reha Triemli Zürich	Zurich
Switzerland	University Hospital Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance Rate	attended sessions / offered sessions	week 12
Other	Adherence Rate	attended training time / offered training time	week 12
Other	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
Other	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
Other	Dose and Content of Usual Care	according to weekly questionnaire, based on TIDIeR checklist	once per week, week 0-24
Other	Amount and Intensity of General Physical and Cognitive Activity	according to weekly questionnaire, based on TIDIeR checklist	once per week, week 0-24
Primary	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	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
Secondary	Change of Simple Reaction Test Parameters	Widely used reliable and valid neuropsychological test assessing alertness	week 0, week 12 and week 24
Secondary	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
Secondary	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
Secondary	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
Secondary	Change of Mental Rotation Test Parameters	Measures the ability to mentally rotate abstract objects	week 0, week 12 and week 24
Secondary	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
Secondary	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
Secondary	Change of Outdoor Gait Parameters	Assesses walking endurance and spatiotemporal gait parameters under daily-life conditions.	week 0, week 12 and week 24