- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07446062
Telerehab Exerbrain: Bridging Physical and Cognitive Therapy in Stroke
Effects of Web-Based Physical-Cognitive Telerehabilitation Exergaming on Physical and Cognitive Performance in Chronic Stroke Survivors: Protocol for a Randomized Controlled Trial
The goal of this clinical trial is to learn if a web-based exercise and cognitive training (physical-cognitive) program works to improve movements and brain function in adults with long-term stroke. It will also learn whether the program is safe and enjoyable.
The main questions it aims to answer are:
Does the program improve walking, balance, strength, and reduce fall risk? Does the program improve cognitive skills such as memory, attention, and problem-solving? Researchers will compare the online exercise-and-cognitive training program to usual care to see if the program leads to greater improvements.
Participants will:
- Be randomly assigned to either the online training group or the usual care group
- If in the training group, complete the home-based program for 12 weeks.
- Take part in physical and cognitive tests before and after the program
Study Overview
Status
Intervention / Treatment
Detailed Description
The goal of this clinical trial is to evaluate whether a 12-week, web-based exercise and cognitive (physical-cognitive) training program can improve both physical abilities and brain function in adults with long-term stroke. The study will also examine whether the program is safe, practical to use at home, and enjoyable.
Many people who have had a stroke continue to experience problems with movement (such as walking, balance, weakness, and risk of falling) as well as problems with cognition (such as memory, attention, and problem-solving). Traditional rehabilitation often focuses mainly on physical recovery. This study tests a program that combines physical exercises and cognitive training at the same time using interactive online "exergames" delivered through telerehabilitation.
The main questions this study aims to answer are:
Does the program improve motor function, walking speed, balance, muscle power, and reduce fall risk? Does the program improve cognitive abilities, including global cognitive ability, executive function, memory, and attention? Is the program enjoyable and feasible for people with chronic stroke to use at home? In this study, 52 participants will be randomly assigned to one of two groups. One group will complete the 12-week web-based physical-cognitive training program at home. Another group will continue receiving their usual care. The researchers will compare changes in physical and cognitive performance between the two groups.
Participants in the training group will follow guided exercise sessions delivered online. All participants will complete physical and cognitive assessments before and after the 12-week period. The results of this study may help determine whether web-based physical-cognitive training is an effective and accessible rehabilitation option for people living with chronic stroke.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Puntarik Keawtep, Ph.D., Primary investigator
- Phone Number: 66 861822590
- Email: puntarik.k@cmu.ac.th
Study Contact Backup
- Name: Somporn Sungkarat, PhD, Associate Professor
- Phone Number: 66814458336
- Email: somporn.sungkarat@cmu.ac.th
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- diagnosed with ischemic or hemorrhagic stroke at least 6 months before enrollment
- aged between 20 and 80 years
- able to walk at least 10 meters with or without assistive devices
- able to perform sit-to-stand safely with or without assistive devices
- can see the screen of a tablet or notebook computer at a distance of at least 60 cm
- have a stable medical condition and can follow study instructions
- frequent users of a mobile phone, tablet, or notebook computers
Exclusion Criteria:
- have medical conditions or complications that would be unsafe to exercise
- have neglect, impaired communication, or uncorrected visual problems [30], or - have severe spasticity of the upper or lower extremities (Modified Ashworth Scale ≥ 3)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Web-Based Physical-Cognitive Telerehabilitation Exergaming
Physical-cognitive exergame via web-based platform at home setting for 60 min/session, 3 sessions/week for 12 weeks.
|
Perform a physical-cognitive exergame via ExerbrainCMU web-based platform at home setting for 60 min/session, 3 sessions/week for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Executive function
Time Frame: 3 months
|
Trail Making Test (TMT) part B-A will be evaluated at baseline and 3 months.
|
3 months
|
|
Fall risk
Time Frame: 3 months
|
Fall risk will be assessed using the Timed Up and Go (TUG) test at baseline and 3 months.
The time taken to complete TUG will be recorded in Sec.
|
3 months
|
|
Gait speed
Time Frame: 3 months.
|
10-Meter Walk test (10MWT) will be used to assessed gait speed at baseline and 3 months.
|
3 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Global cognitive function
Time Frame: 3 months
|
Montreal Cognitive Assessment (MoCA) test will used to measured global cognitive function at baseline and 3 months.The total scores range from 0-30 points with higher scores indicating better global cognitive function.
|
3 months
|
|
Attention
Time Frame: 3 months
|
Digit Span test will be used to assess memory and attention at baseline and 3 months.
|
3 months
|
|
Motor function
Time Frame: 3 months
|
Motor Assessment Scale (MAS) will be used to evaluate motor function at baseline and 3 months.
|
3 months
|
|
Balance
Time Frame: 3 months
|
Modified Functional Reach Test (MFRT) will be used to assessed balance at baseline and 3 months.
|
3 months
|
|
Muscle strength
Time Frame: 3 months
|
Five-Time Sit to Stand will be used to evaluate lower limb muscle strength at baseline and 3 months.
|
3 months
|
|
Weight distribution
Time Frame: 3 months
|
Stance Symmetry Test (SST) will be used to assess weight distribution at baseline and 3 months.
|
3 months
|
|
Enjoyment
Time Frame: 3 months
|
Physical Activity Enjoyment Scale (PACES) will be used to assess enjoyment.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Puntarik Keawtep, Chiang Mai Uiversity
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N42A680192
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University of PittsburghRecruitingHemorrhagic Stroke | Embolic Stroke of Undetermined Source | Ischemic Stroke, Cryptogenic | Recurrent Ischemic Stroke | Ischemic Stroke, EmbolicUnited States
-
National Assembly ClinicBayero University Kano, NigeriaRecruitingStroke | Stroke Hemorrhagic | Stroke Ischemic | Hemiparesis After StrokeNigeria
-
Mahidol UniversityNot yet recruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke SurvivorsThailand
-
Mahidol UniversityRecruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke PatientThailand
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
Fondazione Don Carlo Gnocchi OnlusScuola Superiore Sant'Anna di Pisa; Fondazione Policlinico Universitario Campus...Not yet recruitingStroke | Stroke Hemorrhagic | Upper Limb Rehabilitation | Stroke IschemicItaly
-
Samsung Medical CenterCompletedChronic Stroke | Subacute Stroke | ExoskeletonSouth Korea
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
Clinical Trials on Web-Based Physical-Cognitive Telerehabilitation Exergaming
-
Chiang Mai UniversityCompleted
-
Necmettin Erbakan UniversityCompleted
-
Universitas PadjadjaranCompletedGeriatrics RehabilitationIndonesia
-
Rutgers, The State University of New JerseyNational Institute on Aging (NIA)RecruitingAlzheimer's Disease (AD) | Healthy AgingUnited States
-
Stanford UniversityCompletedDepression | Systemic Lupus Erythematosus | Anxiety | Juvenile Idiopathic Arthritis | Inflammatory Bowel Disease
-
Luleå Tekniska UniversitetNorrbottens County CouncilCompletedMusculoskeletal PainSweden
-
Eskisehir Technical UniversityCompletedSedentary Behavior | Body Image | Physical InactivityTurkey
-
Emory UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)TerminatedDiabetes Mellitus, Type 2United States
-
Helsinki University Central HospitalTurku University Hospital; University of HelsinkiCompleted
-
Wake Forest University Health SciencesNational Center for Advancing Translational Sciences (NCATS)CompletedChronic Musculoskeletal PainUnited States