NCT07494357

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Apr 2026Aug 2026

First Submitted

Initial submission to the registry

March 14, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 14, 2026

Last Update Submit

March 19, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Adherence Rate

    Description: Percentage of attended sessions (out of 12) during the 4-week intervention period.

    4 weeks

  • Retention Rate

    Proportion of participants who complete the full 4-week protocol and follow-up assessments

    4 weeks

  • Incidence of Adverse Events

    Frequency of falls or medical adverse events documented during the training sessions.

    4 weeks

  • Mean Exercise Heart Rate

    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)

  • Mean Systolic and Diastolic Blood Pressure

    Monitoring of hemodynamic stability to ensure the high-intensity circuit training is safe for subacute stroke patients Unit of Measure: Millimeters of mercury (mmHg)

    Pre-and post-each training session (4 weeks)

  • Mean Borg Rating of Perceived Exertion (RPE) Score

    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)

Secondary Outcomes (6)

  • Change from Baseline in 6-Minute Walk Test (6MWT)

    Baseline and 4 weeks

  • Change from Baseline in 10-Meter Walk Test (10MWT)

    Baseline and 4 weeks

  • Change from Baseline of Completion Time in Standardized Walking Obstacle Course (SWOC)

    Baseline and 4 weeks

  • Change from Baseline in Standardized Walking Obstacle Course (SWOC) Step Count

    Baseline and 4 weeks

  • Change of number of errors in Standardized Walking Obstacle Course (SWOC)

    Baseline and 4 weeks (Post-intervention)

  • +1 more secondary outcomes

Study Arms (3)

Dual Task Oriented Circuit Training (DTOCT)

EXPERIMENTAL

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.

Behavioral: Dual task oriented circuit training

Task Oriented Circuit Training (TOCT)

ACTIVE COMPARATOR

Behavioral: Task-Oriented Circuit Training. Focuses on high-intensity motor repetition using circuit stations (e.g., sit-to-stand, stepping) without added cognitive load.

Behavioral: Dual task training

Dual Task Training (DTT)

ACTIVE COMPARATOR

Behavioral: Pure Dual-Task Training. Participants practice walking under cognitive load (e.g., Stroop task) in a standard non-circuit format.

Behavioral: Task Oriented Circuit Training

Interventions

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

Also known as: DTOCT
Dual Task Oriented Circuit Training (DTOCT)

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.

Also known as: TOCT
Dual Task Training (DTT)

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.

Also known as: DTT
Task Oriented Circuit Training (TOCT)

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RS Dustira Bandung

Bandung, West Java, 40131, Indonesia

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Farida Arisanti, MD, PMR

    Faculty of Medicine Universitas Padjadjaran

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Farida Arisanti, MD, PMR

CONTACT

Vitriana Biben, Prof., MD, PMR

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel asgnment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PMR

Study Record Dates

First Submitted

March 14, 2026

First Posted

March 27, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations