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Think 'n' Move: Motor-cognitive Training in Chronic Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Concept-guided, personalized, motor-cognitive training by means of an exergame
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring cognition, gait, mobility, training, chronic stroke, rehabilitation, virtual reality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kantonsspital WinterthurRecruiting
  • Ambulante Reha Triemli ZürichRecruiting
  • University Hospital ZürichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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

Usual care only

Outcomes

Primary Outcome Measures

Change of Montreal Cognitive Assessment Score
Widely used screening tool and cognitive outcome in neurological patients including stroke

Secondary Outcome Measures

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

Full Information

First Posted
August 2, 2022
Last Updated
October 4, 2022
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT05524727
Brief Title
Think 'n' Move: Motor-cognitive Training in Chronic Stroke
Official Title
Think 'n' Move: Evaluating the Effects of a Concept-guided, Personalized, Motor-cognitive Training in Chronic Stroke - a RCT
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
cognition, gait, mobility, training, chronic stroke, rehabilitation, virtual reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Usual care + concept-guided, personalized, motor-cognitive training by means of an exergame
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Usual care only
Intervention Type
Other
Intervention Name(s)
Concept-guided, personalized, motor-cognitive training by means of an exergame
Intervention Description
12 weeks, two times per week for 30-40min
Primary Outcome Measure Information:
Title
Change of Montreal Cognitive Assessment Score
Description
Widely used screening tool and cognitive outcome in neurological patients including stroke
Time Frame
week 0, week 12 and week 24
Secondary Outcome Measure Information:
Title
Change of Stroke Impact Scale 3.0 Score
Description
Stroke-specific measurement tool assessing patient-reported health-related quality of life
Time Frame
week 0, week 12 and week 24
Title
Change of Simple Reaction Test Parameters
Description
Widely used reliable and valid neuropsychological test assessing alertness
Time Frame
week 0, week 12 and week 24
Title
Change of Trail Making Test A & B Parameters
Description
Widely used reliable and valid neuropsychological test assessing processing speed and executive functions
Time Frame
week 0, week 12 and week 24
Title
Change of Stroop Interference Test Parameters
Description
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
Time Frame
week 0, week 12 and week 24
Title
Change of N-back test Parameters
Description
Widely used reliable and valid neuropsychological test assessing working memory and related cognitive functions
Time Frame
week 0, week 12 and week 24
Title
Change of Mental Rotation Test Parameters
Description
Measures the ability to mentally rotate abstract objects
Time Frame
week 0, week 12 and week 24
Title
Change in Single- and cognitive Dual-Task Timed Up and Go Test Parameters and motor/cognitive dual task costs
Description
Widely used, reliable and valid test of mobility and dual-task ability in various populations including stroke.
Time Frame
week 0, week 12 and week 24
Title
Change of 10 meter walk test Gait Parameters
Description
Widely used test to assess gait speed and spatiotemporal gait parameters.
Time Frame
week 0, week 12 and week 24
Title
Change of Outdoor Gait Parameters
Description
Assesses walking endurance and spatiotemporal gait parameters under daily-life conditions.
Time Frame
week 0, week 12 and week 24
Other Pre-specified Outcome Measures:
Title
Compliance Rate
Description
attended sessions / offered sessions
Time Frame
week 12
Title
Adherence Rate
Description
attended training time / offered training time
Time Frame
week 12
Title
Perceived Motor-Cognitive Task Difficulty
Description
visual analogue scale after each training session, based on cognitive load theory, scale from 1-9, where 9 symbolizes most difficult
Time Frame
twice per week, week 0-12
Title
Perceived Performance
Description
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
Time Frame
twice per week, week 0-12
Title
Dose and Content of Usual Care
Description
according to weekly questionnaire, based on TIDIeR checklist
Time Frame
once per week, week 0-24
Title
Amount and Intensity of General Physical and Cognitive Activity
Description
according to weekly questionnaire, based on TIDIeR checklist
Time Frame
once per week, week 0-24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rudolf Knols, PhD
Phone
+41442558809
Email
ruud.knols@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Simone Huber, MSc
Phone
+41432531480
Email
simone.huber@usz.ch
Facility Information:
Facility Name
Kantonsspital Winterthur
City
Winterthur
State/Province
Zurich
ZIP/Postal Code
8400
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martina Betschart, PhD
Email
martina1.betschart@ksw.ch
Facility Name
Ambulante Reha Triemli Zürich
City
Zurich
ZIP/Postal Code
8063
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremia Held, PhD
Email
jeremia.held@kliniken-valens.ch
Facility Name
University Hospital Zürich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone Huber, MSc. ETH
Phone
+41432531480
Email
simone.huber@usz.ch

12. IPD Sharing Statement

Learn more about this trial

Think 'n' Move: Motor-cognitive Training in Chronic Stroke

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