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

Официальное название

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)

Обзор

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.

Вмешательства

• Поведенческое ReMap
  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 Expansi
• Поведенческое Usual Care
  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

Первичные конечные точки

• Change from baseline in mobility assessed by the Timed Up and Go (TUG) test [Срок оценки: Baseline, Week 4, and Week 8 (Primary comparison is the change from baseline to Week 4)]

Вторичные конечные точки (7)

• Change from baseline in health-related quality of life assessed by the EORTC QLQ-C30 [Срок оценки: Baseline, Week 4, and Week 8]
• Change from baseline in chemotherapy-induced peripheral neuropathy (CIPN) symptoms assessed by the EORTC QLQ-CIPN20 [Срок оценки: 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) [Срок оценки: Baseline, Week 4, and Week 8]
• Change from baseline in fall risk assessed by the Fall Assessment Scale - Korean version (FAS-K) [Срок оценки: Baseline, Week 4, and Week 8]
• Change from baseline in walking endurance assessed by the 6-Minute Walk Test (6MWT) [Срок оценки: Baseline, Week 4, and Week 8]
• Change from baseline in handgrip strength [Срок оценки: Baseline, Week 4, and Week 8]
• Change from baseline in kinematic parameters of movement assessed by video-based motion analysis [Срок оценки: Baseline, Week 4, and Week 8]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

South Korea · 1 центр

• Seoul National University Bundang Hospital — Seongnam-si

Идентификаторы

NCT: NCT07714278 · Q-2026-387

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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