Effectiveness of Video-Based Movement Analysis-Guided Personalized Rehabilitation in Patients With CIPN: A Multicenter Trial | NCT07714278

NCT07714278

Overview

NCT ID: NCT07714278
Lead Sponsor: Seoul National University Bundang HospitalOTHER
Official 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)
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.

Status and Timeline

Status: Enrolling by invitation
Last Update Posted: Jul 20, 2026Actual
Start Date: Jun 30, 2026Estimated
Primary Completion Date: May 31, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 150Estimated
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Single

Contacts and Locations

Central Contacts: No data available
Locations: Seoul National University Bundang Hospital

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

Similar Studies