Effectiveness of Video-Based Movement Analysis-Guided Personalized Rehabilitation in Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)

N/AEnrolling By InvitationNCT07714278

Seoul National University Bundang Hospital150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

150

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN)

Interventions

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 CareBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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.