Effects of Dual Task-Oriented Circuit Training on Walking Recovery in Sub-acute Stroke

Official title

The Effect of Dual Task-Oriented Circuit Training on Neuroplasticity and Walking Adaptability in Subacute Stroke Patients: A Pilot and Feasibility Study

Overview

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

• Behavioral Dual 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: Steppin
• Behavioral Task 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
• Behavioral Dual 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

Primary outcome measures

• Adherence Rate [Time frame: 4 weeks]
• Retention Rate [Time frame: 4 weeks]
• Incidence of Adverse Events [Time frame: 4 weeks]
• Mean Exercise Heart Rate [Time frame: During each of the 12 training sessions (4 weeks)]
• Mean Systolic and Diastolic Blood Pressure [Time frame: Pre-and post-each training session (4 weeks)]
• Mean Borg Rating of Perceived Exertion (RPE) Score [Time frame: At the end of each circuit station during all 12 sessions (4 weeks)]

Secondary outcome measures (6)

• Change from Baseline in 6-Minute Walk Test (6MWT) [Time frame: Baseline and 4 weeks]
• Change from Baseline in 10-Meter Walk Test (10MWT) [Time frame: Baseline and 4 weeks]
• Change from Baseline of Completion Time in Standardized Walking Obstacle Course (SWOC) [Time frame: Baseline and 4 weeks]
• Change from Baseline in Standardized Walking Obstacle Course (SWOC) Step Count [Time frame: Baseline and 4 weeks]
• Change of number of errors in Standardized Walking Obstacle Course (SWOC) [Time frame: Baseline and 4 weeks (Post-intervention)]
• Change from Baseline in Serum BDNF Concentration [Time frame: Baseline and 4 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Indonesia · 1 center

• RS Dustira Bandung — Bandung

Identifiers

NCT: NCT07494357 · IKFR-202603.01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗