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

NCT07714278 | Enrolling By Invitation

• 1 other identifier: Q-2026-387
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN)

Keywords

Falls; Rehabilitation; Postural Balance; Motor Control; Motion Analysis; Breast Cancer; Colorectal Cancer; Gynecological Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (7)

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

  Baseline, Week 4, and Week 8

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

  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)

  Baseline, Week 4, and Week 8

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

  Baseline, Week 4, and Week 8

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

  Baseline, Week 4, and Week 8

Study Arms (2)

Active Comparator: Group A (ReMAP then Usual Care)

EXPERIMENTAL

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

Active Comparator: Group B (Usual Care then ReMAP)

ACTIVE COMPARATOR

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

Interventions

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）

Active Comparator: Group A (ReMAP then Usual Care); Active Comparator: Group B (Usual Care then ReMAP)

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.

Active Comparator: Group A (ReMAP then Usual Care); Active Comparator: Group B (Usual Care then ReMAP)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Eun Joo Yang, MD, PhD

  Seoul National University Bundang Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: "This is a 2-period crossover trial. Participants are randomized to either Group A (4 weeks of the 'ReMAP' program followed by 4 weeks of usual care) or Group B (4 weeks of usual care followed by 4 weeks of the 'ReMAP' program)."

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)