Stroke, Cerebrovascular
Conditions
Brief summary
This pilot study aims to assess the feasibility, safety, and initial efficacy of an integrated Dual Task-Oriented Circuit Training (DTOCT) program for individuals in the subacute phase of stroke recovery. Although numerous patients recover the capacity to walk in a regulated hospital environment, they frequently encounter difficulties with "community ambulation," the capability to traverse real-world settings while multitasking (e.g., walking while conversing or circumventing barriers). This study will examine if the integration of high-intensity circuit training with cognitive difficulties can promote neuroplasticity and enhance the patient's capacity to safely traverse intricate daily settings.
Detailed description
Cognitive-Motor Interference (CMI) makes it challenging for stroke survivors to reintegrate into their communities. Walking is an automatic subcortical process in a healthy brain. After a stroke, however, the brain often has to "consciously" control walking, which takes away mental resources from other tasks. This "functional gap" is why almost 80% of survivors can walk house-hold, but only 30% can safely get around in the community. This study examines the "Golden Window" of recovery (2 weeks to 5 months post-stroke), a timeframe characterized by optimal physiological conditions for neuroplasticity. The DTOCT protocol functions as a synergistic intervention: the circuit training induces cardiovascular intensity to stimulate systemic Brain-Derived Neurotrophic Factor (BDNF) release, while concurrent cognitive tasks (e.g., memory recall or the Stroop test) focus on localized neurotrophic support within the prefrontal cortex and hippocampus. This three-arm pilot study (DTOCT vs. pure task-oriented training vs. pure dual-tasking) will give us important information about how easy it is to recruit participants, how well they stick to the plan, and how big the initial effects are. These results will constitute an essential basis for an upcoming comprehensive Randomized Controlled Trial (RCT) designed to enhance the standard of neurorehabilitation in Indonesia.
Interventions
BEHAVIORALDual task oriented circuit training
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
BEHAVIORALTask Oriented Circuit Training
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.
BEHAVIORALDual task training
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.
Sponsors
Universitas Padjadjaran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Parallel asgnment
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with a first-ever subacute stroke (defined as 2 weeks to 5 months post-onset) with anterior circulation involvement. 2. Diagnosis confirmed via neuroimaging (CT or MRI). 3. Men and women aged 40 to 65 years. 4. Motor recovery in the lower limbs corresponding to Brunnstrom stages 4 to 5. Functional Ambulation Category (FAC) score of at least grade 3. 6. Ability to walk independently, with or without walking aids. 7. Montreal Cognitive Assessment Indonesian version (MoCA-INA) score of ≥20, demonstrating the capacity to collaborate and follow multi-step instructions. 8. Medically stable with controlled comorbidities.
Exclusion criteria
1. Expressive or receptive aphasia that impedes task comprehension 2. Unstable cardiovascular or medical conditions (e.g., severe hypertension, congestive heart failure) for which moderate exercise is contraindicated. 3. Moderate to severe depression, indicated by a Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence Rate | 4 weeks | Description: Percentage of attended sessions (out of 12) during the 4-week intervention period. |
| Retention Rate | 4 weeks | Proportion of participants who complete the full 4-week protocol and follow-up assessments |
| Incidence of Adverse Events | 4 weeks | Frequency of falls or medical adverse events documented during the training sessions. |
| Mean Exercise Heart Rate | During each of the 12 training sessions (4 weeks) | 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) |
| Mean Systolic and Diastolic Blood Pressure | Pre-and post-each training session (4 weeks) | Monitoring of hemodynamic stability to ensure the high-intensity circuit training is safe for subacute stroke patients Unit of Measure: Millimeters of mercury (mmHg) |
| Mean Borg Rating of Perceived Exertion (RPE) Score | At the end of each circuit station during all 12 sessions (4 weeks) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in 6-Minute Walk Test (6MWT) | Baseline and 4 weeks | Change in total distance walked in meters during the 6-Minute Walk Test from baseline to 4 weeks. |
| Change from Baseline in 10-Meter Walk Test (10MWT) | Baseline and 4 weeks | Change in gait speed measured in meters per second (m/s) in 10 meter walk test |
| Change from Baseline of Completion Time in Standardized Walking Obstacle Course (SWOC) | Baseline and 4 weeks | 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 |
| Change from Baseline in Standardized Walking Obstacle Course (SWOC) Step Count | Baseline and 4 weeks | Mean number of contacts between the foot and ground during course completion across three conditions Unit of measure : Number of steps |
| Change of number of errors in Standardized Walking Obstacle Course (SWOC) | Baseline and 4 weeks (Post-intervention) | 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") |
| Change from Baseline in Serum BDNF Concentration | Baseline and 4 weeks | Concentration of Brain-Derived Neurotrophic Factor quantified via sandwich ELISA to measure neuroplasticity. Unit of measure : Picograms per milliliter (pg/mL) |
Countries
Indonesia
Contacts
CONTACTFarida Arisanti, MD, PMR
CONTACTVitriana Biben, Prof., MD, PMR
PRINCIPAL_INVESTIGATORFarida Arisanti, MD, PMR
Faculty of Medicine Universitas Padjadjaran
Outcome results
None listed