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Enrolling By Invitation NCT07714278

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

Conditions: Chemotherapy-induced Peripheral Neuropathy (CIPN)

Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: Seoul National University Bundang Hospital

Location: Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do

Summary

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07714278). StuddyBuddy aggregates publicly available trial information.