- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07494357
Effects of Dual Task-Oriented Circuit Training on Walking Recovery in Sub-acute Stroke (DTOCT-Stroke)
The Effect of Dual Task-Oriented Circuit Training on Neuroplasticity and Walking Adaptability in Subacute Stroke Patients: A Pilot and Feasibility Study
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Farida Arisanti, MD, PMR
- Phone Number: +62-85351111946
- Email: farida.arisanti@unpad.ac.id
Study Contact Backup
- Name: Vitriana Biben, Prof., MD, PMR
- Phone Number: +628156262733
- Email: vitriana@unpad.ac.id
Study Locations
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West Java
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Bandung, West Java, Indonesia, 40131
- RS Dustira Bandung
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Contact:
- Bernadeta Cahyo Setianingrum Poernomo, MD, PMR
- Phone Number: +6281214544779
- Email: nuningbernadeta@ymail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Diagnosed with a first-ever subacute stroke (defined as 2 weeks to 5 months post-onset) with anterior circulation involvement.
- Diagnosis confirmed via neuroimaging (CT or MRI).
- Men and women aged 40 to 65 years.
- Motor recovery in the lower limbs corresponding to Brunnstrom stages 4 to
- Functional Ambulation Category (FAC) score of at least grade 3.
- Ability to walk independently, with or without walking aids.
- Montreal Cognitive Assessment Indonesian version (MoCA-INA) score of ≥20, demonstrating the capacity to collaborate and follow multi-step instructions.
- Medically stable with controlled comorbidities.
Exclusion Criteria
- Expressive or receptive aphasia that impedes task comprehension
- Unstable cardiovascular or medical conditions (e.g., severe hypertension, congestive heart failure) for which moderate exercise is contraindicated.
- Moderate to severe depression, indicated by a Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15.
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 |
|---|---|
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Experimental: Dual Task Oriented Circuit Training (DTOCT)
Experimental: DTOCT Behavioral: Dual Task-Oriented Circuit Training.
Participants engage in 5 circuit stations (e.g., obstacle walking, stair navigation) while performing secondary cognitive tasks (e.g., backward counting, object naming).
3 sessions/week for 4 weeks.
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1. Experimental Arm: Dual Task-Oriented Circuit Training (DTOCT) Intervention Name: Behavioral: Dual Task-Oriented Circuit Training (DTOCT) Description: Participants will undergo an integrated 60-minute rehabilitation session, 3 times per week for 4 weeks (total 12 sessions). Each session includes 25-50 minutes of active circuit training across five specialized stations: Dual-Task Walking: Straight walking (3-8m) while performing forward/backward number sequencing. Obstacle Walking: Stepping over cone or hurdle obstacles (5-14cm) while naming object categories from long-term memory. Stair Navigation: Ascending/descending stairs (10-17cm step height) while identifying colors and shapes. Walking with Navigation: Navigating an oval path (3-8m) while performing an incongruent Stroop color-word task. ADL Stimulation: Walking while carrying a cup of liquid or a shopping bag to train executive function and working memory. Training intensity and cognitive difficulty are progressed weekly
Other Names:
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Active Comparator: Dual Task Training (DTT)
Behavioral: Pure Dual-Task Training.
Participants practice walking under cognitive load (e.g., Stroop task) in a standard non-circuit format.
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3. Active Comparator Arm: Pure Dual-Task Training (DT) Intervention Name: Behavioral: Pure Dual-Task Training (DT) Description: Participants will perform standard, non-circuit walking at a self-selected comfortable speed while executing simultaneous cognitive demands. The protocol includes: Backward Counting: Continuous subtraction from a random 3-digit number. Stroop Task: Identifying font colors or semantic meanings of incongruent words. Memory Tasks: Sequential recall of shopping lists (3-5 items) and reverse word recall (2-4 words). Verbal Fluency: Generating word chains or category naming. Each session consists of two 15-minute sets of core dual-task training (30 minutes total activity) within a 60-minute therapist-supervised visit. Training is conducted 3 times per week for 4 weeks (total 12 sessions). Cognitive difficulty is adjusted weekly to maintain an optimal challenge.
Other Names:
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Active Comparator: Task Orinted Circuit Training (TOCT)
Behavioral: Task-Oriented Circuit Training.
Focuses on high-intensity motor repetition using circuit stations (e.g., sit-to-stand, stepping) without added cognitive load.
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2. Active Comparator Arm: Task-Oriented Circuit Training (TOCT) Intervention Name: Behavioral: Task-Oriented Circuit Training (TOCT) Description: Participants will focus exclusively on functional motor relearning and cardiovascular endurance through 6 circuit-based stations: Standing and Reaching: Multidirectional reaching to targets while standing. Sit-to-Stand: Transitions using chairs of various heights to strengthen extensors. Anterior/Posterior Stepping: Stepping onto blocks of various heights. Lateral Stepping: Side-stepping for lateral stability. Forward Step-Up: Strengthening for stair climbing mechanics. Heel Raise: Improving gait push-off mechanics. Each station is performed for 2.5 to 5 minutes with 1-minute rest periods. Training is conducted 3 times per week for 4 weeks (total 12 sessions), with each session lasting 60 minutes including warm-up and cool-down. No explicit secondary cognitive tasks are added.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence Rate
Time Frame: 4 weeks
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Description: Percentage of attended sessions (out of 12) during the 4-week intervention period.
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4 weeks
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Retention Rate
Time Frame: 4 weeks
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Proportion of participants who complete the full 4-week protocol and follow-up assessments
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4 weeks
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Incidence of Adverse Events
Time Frame: 4 weeks
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Frequency of falls or medical adverse events documented during the training sessions.
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4 weeks
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Mean Exercise Heart Rate
Time Frame: During each of the 12 training sessions (4 weeks)
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Evaluation of cardiovascular demand and tolerability during the circuit training stations. Measured using a digital heart rate monitor. Unit of Measure: Beats per minute (bpm) |
During each of the 12 training sessions (4 weeks)
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Mean Systolic and Diastolic Blood Pressure
Time Frame: Pre-and post-each training session (4 weeks)
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Monitoring of hemodynamic stability to ensure the high-intensity circuit training is safe for subacute stroke patients Unit of Measure: Millimeters of mercury (mmHg)
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Pre-and post-each training session (4 weeks)
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Mean Borg Rating of Perceived Exertion (RPE) Score
Time Frame: At the end of each circuit station during all 12 sessions (4 weeks)
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Assessment of subjective physical effort and tolerability. The scale ranges from 6 to 20 (or 0-10 depending on the version used), where higher scores indicate greater perceived exertion. Unit of Measure: Units on a scale |
At the end of each circuit station during all 12 sessions (4 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in 6-Minute Walk Test (6MWT)
Time Frame: Baseline and 4 weeks
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Change in total distance walked in meters during the 6-Minute Walk Test from baseline to 4 weeks.
|
Baseline and 4 weeks
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Change from Baseline in 10-Meter Walk Test (10MWT)
Time Frame: Baseline and 4 weeks
|
Change in gait speed measured in meters per second (m/s) in 10 meter walk test
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Baseline and 4 weeks
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Change from Baseline of Completion Time in Standardized Walking Obstacle Course (SWOC)
Time Frame: Baseline and 4 weeks
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Mean time taken to complete the 12.2-meter curved course across three conditions (normal, tray, dark-glasses) and measured using a stopwatch. The total time in seconds taken to complete the 12.2-meter curved obstacle course under three conditions (normal, tray, and dark-glasses). A shorter time indicates better walking adaptability. Unit of Measure: Seconds |
Baseline and 4 weeks
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Change from Baseline in Standardized Walking Obstacle Course (SWOC) Step Count
Time Frame: Baseline and 4 weeks
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Mean number of contacts between the foot and ground during course completion across three conditions Unit of measure : Number of steps
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Baseline and 4 weeks
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Change of number of errors in Standardized Walking Obstacle Course (SWOC)
Time Frame: Baseline and 4 weeks (Post-intervention)
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Errors are operationally defined as the aggregate sum of "stumbles" (where the participant's leg or walking aid strikes an obstacle) and "step-offs" (where a whole foot is placed outside the 0.92-meter wide curved pathway) Number of errors (atau "Count of errors")
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Baseline and 4 weeks (Post-intervention)
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Change from Baseline in Serum BDNF Concentration
Time Frame: Baseline and 4 weeks
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Concentration of Brain-Derived Neurotrophic Factor quantified via sandwich ELISA to measure neuroplasticity. Unit of measure : Picograms per milliliter (pg/mL) |
Baseline and 4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Farida Arisanti, MD, PMR, Faculty of Medicine Universitas Padjadjaran
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
- IKFR-202603.01
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.
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