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NCT Number: NCT07714278

Effectiveness of Video-Based Movement Analysis-Guided Personalized Rehabilitation in Patients With CIPN: A Multicenter Trial

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.

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Key information

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN) Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients aged 19 years or older.
  • Diagnosed with breast cancer, colorectal cancer, or gynecological cancer, and currently receiving chemotherapy or under follow-up observation after completing treatment.
  • History of treatment with neurotoxic chemotherapeutic agents (e.g., taxane, platinum, etc.) or experiencing related symptoms.
  • Symptoms or risk of chemotherapy-induced peripheral neuropathy (CIPN) (NCI-CTCAE Grade >= 1).
  • Able to walk independently (with or without assistive devices).
  • Able to understand the study purpose and procedures and voluntarily provide written informed consent.

Exclusion criteria

  • Peripheral neuropathy clearly attributable to causes other than CIPN, such as diabetic neuropathy.
  • Severe central nervous system disorders (e.g., stroke, Parkinson's disease, etc.) or severe musculoskeletal disorders that make functional assessment or exercise performance difficult.
  • Severe cognitive impairment that interferes with study participation or the ability to follow instructions.
  • Recent significant injury due to a fall, or cases where exercise performance is deemed medically unsafe.
  • Recurrent or progressive cancer with an unstable general systemic condition.
  • Any other condition or clinical reason that, in the opinion of the investigator, makes participation in the study inappropriate.

Treatment and study plan

ReMap

Behavioral

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）

Usual Care

Behavioral

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.

Primary outcomes

  1. Change from baseline in mobility assessed by the Timed Up and Go (TUG) test

    Time frame: Baseline, Week 4, and Week 8 (Primary comparison is the change from baseline to Week 4)

    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.

Secondary outcomes

  1. Change from baseline in health-related quality of life assessed by the EORTC QLQ-C30

    Time frame: Baseline, Week 4, and Week 8

    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.

  2. Change from baseline in chemotherapy-induced peripheral neuropathy (CIPN) symptoms assessed by the EORTC QLQ-CIPN20

    Time frame: Baseline, Week 4, and Week 8

    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.

  3. Change from baseline in disability and functioning assessed by the WHODAS 2.0 (World Health Organization Disability Assessment Schedule 2.0)

    Time frame: Baseline, Week 4, and Week 8

    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.

  4. Change from baseline in fall risk assessed by the Fall Assessment Scale - Korean version (FAS-K)

    Time frame: Baseline, Week 4, and Week 8

    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.

  5. Change from baseline in walking endurance assessed by the 6-Minute Walk Test (6MWT)

    Time frame: Baseline, Week 4, and Week 8

    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.

  6. Change from baseline in handgrip strength

    Time frame: Baseline, Week 4, and Week 8

    Handgrip strength is measured in kilograms (kg) using a digital hand dynamometer. Higher values indicate greater upper extremity muscle strength.

  7. Change from baseline in kinematic parameters of movement assessed by video-based motion analysis

    Time frame: Baseline, Week 4, and Week 8

    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.

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

A Multicenter Investigator-Initiated Clinical Trial Evaluating the Effectiveness of Video-Based Movement Analysis-Guided Personalized Rehabilitation in Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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