An interventional study of ReMap and Usual Care in Chemotherapy-induced Peripheral Neuropathy (CIPN), sponsored by Seoul National University Bundang Hospital. Enrolling by invitation at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Supportive care
This study aims to quantify motor control abnormalities using video-based movement analysis in patients with chemotherapy-induced peripheral neuropathy (CIPN) and to evaluate the effectiveness of an analysis-guided personalized rehabilitation intervention. The study enrolls adult patients diagnosed with breast cancer, colorectal cancer, or gynecological cancer.
This is a randomized crossover trial where participants have an equal (50%) chance of being assigned to either Group A or Group B. The total participation period for each participant is approximately 8 weeks, which includes outcome assessments at baseline, week 4, and week 8.
The study consists of two periods:
Phase 1 (First 4 weeks): Group A participates in the 'ReMAP' rehabilitation exercise program, while Group B receives usual care.
Phase 2 (Next 4 weeks): Group A switches to usual care, while Group B participates in the 'ReMAP' rehabilitation exercise program.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 150 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Seoul National University Bundang Hospital is the lead sponsor of 376 studies on the registry; 56 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to Group A will first perform the 4-week 'ReMAP' rehabilitation program (Phase 1), and then cross over to receive 4 weeks of usual care (Phase 2).
Behavioral: ReMap · Behavioral: Usual Care
Participants randomized to Group B will first receive 4 weeks of usual care (Phase 1), and then cross over to perform the 4-week 'ReMAP' rehabilitation program (Phase 2).
Behavioral: ReMap · Behavioral: Usual Care
The intervention is conducted over a total of 4 weeks, with 3 sessions per week, for a total of 12 sessions, with each session lasting approximately 40-60 minutes. Each session consists of warm-up, breathing training, upper and lower extremity exercises, trunk and total-body coordination exercises, and cool-down, following a structured progression with gradually increasing difficulty. The program begins with the "Body Awareness and Basic Adaptation" phase and progresses through "Movement Expansion," "Coordination and Dynamic Balance," and finally, the "Functional Activity Integration" phase. Week 1: Postural alignment and body midline awareness training (goal : Postural alignment) Week 2 : Lateral weight shifting and upper/lower extremity coordination training (goal : Coordination) Week 3 : Movement balance and functional gait pattern training (goal : Dynamic balance) Week 4 : Complex movement and functional movement integration training (goal : Functional integration）
During the initial 4 weeks, the control group maintains usual care and routine self-management without any structured rehabilitation. This usual care includes standard pharmacological treatment, symptom management, and general lifestyle education guided by their healthcare providers; no study-specific exercise programs are provided. Participants are instructed to maintain ordinary activities of daily living but advised not to initiate any new exercise regimens or rehabilitation programs during this period. The control group follows the exact same assessment schedule as the intervention group to track CIPN symptoms, functional status, and fall risks. For ethical considerations, a wait-list design is applied: control participants will cross over to receive the identical 4-week ReMAP-CIPN rehabilitation program immediately after their 4-week post-baseline evaluation.
Change from baseline in mobility assessed by the Timed Up and Go (TUG) test
The TUG test measures the time (in seconds) it takes for a participant to rise from a chair, walk 3 meters, turn around, walk back, and sit down. Shorter completion times indicate better mobility and dynamic balance. This is the primary outcome of the study, which served as the basis for the sample size calculation.
Time frame: Baseline, Week 4, and Week 8 (Primary comparison is the change from baseline to Week 4)
Change from baseline in health-related quality of life assessed by the EORTC QLQ-C30
The EORTC QLQ-C30 is a 30-item questionnaire evaluating the quality of life of cancer patients. It includes functional scales, symptom scales, and a global health status. Scores range from 0 to 100. For functional scales and global health, higher scores represent better functioning/QoL. For symptom scales, higher scores represent worse symptoms.
Time frame: Baseline, Week 4, and Week 8
Change from baseline in chemotherapy-induced peripheral neuropathy (CIPN) symptoms assessed by the EORTC QLQ-CIPN20
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 CIPN twenty-item subscale (EORTC QLQ-CIPN20) will be used to assess sensory, motor, and autonomic CIPN symptoms. Scores range from 20 to 80, which are then converted to a 0-100 scale. Higher scores represent more severe symptoms.
Time frame: Baseline, Week 4, and Week 8
Change from baseline in disability and functioning assessed by the WHODAS 2.0 (World Health Organization Disability Assessment Schedule 2.0)
The WHODAS 2.0 is a 36-item instrument used to measure health and disability in daily life across six domains. Scores range from 0 (no disability) to 100 (full disability), with higher scores indicating greater functional impairment.
Time frame: Baseline, Week 4, and Week 8
Change from baseline in fall risk assessed by the Fall Assessment Scale - Korean version (FAS-K)
The FAS-K is a clinical assessment tool used to evaluate the objective risk of falls in adult patients based on 14 risk-associated items (e.g., age, history of falls, cognitive status, medications, and mobility). Each item is scored as 1 (Yes) or 0 (No). The total score ranges from 0 to 14, with higher scores indicating a higher clinical risk of falls.
Time frame: Baseline, Week 4, and Week 8
Change from baseline in walking endurance assessed by the 6-Minute Walk Test (6MWT)
The 6MWT measures the maximum distance (in meters) a participant can walk quickly on a flat, hard surface in 6 minutes. Longer distances indicate better walking endurance and functional exercise capacity.
Time frame: Baseline, Week 4, and Week 8
Change from baseline in handgrip strength
Handgrip strength is measured in kilograms (kg) using a digital hand dynamometer. Higher values indicate greater upper extremity muscle strength.
Time frame: Baseline, Week 4, and Week 8
Change from baseline in kinematic parameters of movement assessed by video-based motion analysis
Video-based motion analysis will evaluate 6 designated tasks (including gait, weight shifting, and postural balance) captured from anterior-posterior (AP) and lateral views. Quantitative assessment metrics will include sway control, verticality control, alignment, coordination, and smoothness.
Time frame: Baseline, Week 4, and Week 8
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for May 2028, 23 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 23 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
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Seoul National University Bundang Hospital →