Chemotherapy-induced Peripheral Neuropathy (CIPN)NCT07714278
Effectiveness of Video-Based Movement Analysis-Guided Personalized Rehabilitation in Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)
A study testing ReMap in people with Chemotherapy-induced Peripheral Neuropathy (CIPN), run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy (CIPN)
- What is being tested?
- ReMap
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jun 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
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)
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.
Read more
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.
- Being tested
- ReMap, Usual Care
- Keywords
- Falls, Rehabilitation, Postural Balance, Motor Control, Motion Analysis, Breast Cancer, Colorectal Cancer, Gynecological Cancer
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReMapBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: ReMap; Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline, Week 4, and Week 8
Change from baseline in chemotherapy-induced peripheral neuropathy (CIPN) symptoms assessed by the EORTC QLQ-CIPN20
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 CIPN twenty-item subscale (EORTC QLQ-CIPN20) will be used to assess sensory, motor, and autonomic CIPN symptoms. Scores range from 20 to 80, which are then converted to a 0-100 scale. Higher scores represent more severe symptoms.
Measured: 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)
The WHODAS 2.0 is a 36-item instrument used to measure health and disability in daily life across six domains. Scores range from 0 (no disability) to 100 (full disability), with higher scores indicating greater functional impairment.
Measured: Baseline, Week 4, and Week 8
Change from baseline in fall risk assessed by the Fall Assessment Scale - Korean version (FAS-K)
The FAS-K is a clinical assessment tool used to evaluate the objective risk of falls in adult patients based on 14 risk-associated items (e.g., age, history of falls, cognitive status, medications, and mobility). Each item is scored as 1 (Yes) or 0 (No). The total score ranges from 0 to 14, with higher scores indicating a higher clinical risk of falls.
Measured: Baseline, Week 4, and Week 8
Change from baseline in walking endurance assessed by the 6-Minute Walk Test (6MWT)
The 6MWT measures the maximum distance (in meters) a participant can walk quickly on a flat, hard surface in 6 minutes. Longer distances indicate better walking endurance and functional exercise capacity.
Measured: Baseline, Week 4, and Week 8
Change from baseline in handgrip strength
Handgrip strength is measured in kilograms (kg) using a digital hand dynamometer. Higher values indicate greater upper extremity muscle strength.
Measured: Baseline, Week 4, and Week 8
Change from baseline in kinematic parameters of movement assessed by video-based motion analysis
Video-based motion analysis will evaluate 6 designated tasks (including gait, weight shifting, and postural balance) captured from anterior-posterior (AP) and lateral views. Quantitative assessment metrics will include sway control, verticality control, alignment, coordination, and smoothness.
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start30 Jun 2026
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral Neuropathy (CIPN)Studies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- "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)."
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Joo Yang, Seoul National University Bundang Hospital
- Investigators
- Eun Joo Yang, MD, PhD, Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714278
- Sponsor's protocol ID
- Q-2026-387
- Status last verified
- Aug 2026
- First submitted
- 15 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07714278
- Acronym / sponsor ID
- Q-2026-387
- Keywords
- Falls, Rehabilitation, Postural Balance, Motor Control, Motion Analysis, Breast Cancer, Colorectal Cancer, Gynecological Cancer
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- "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)."
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Group A (ReMAP then Usual Care) | Experimental | Behavioral: ReMap, Behavioral: Usual CareParticipants 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). |
| Active Comparator: Group B (Usual Care then ReMAP) | Active comparator | Behavioral: ReMap, Behavioral: Usual CareParticipants 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). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReMapThe 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） | Behavioural | Active Comparator: Group A (ReMAP then Usual Care), Active Comparator: Group B (Usual Care then ReMAP) |
| Usual CareDuring 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. | Behavioural | Active Comparator: Group A (ReMAP then Usual Care), Active Comparator: Group B (Usual Care then ReMAP) |
Primary outcome
Change from baseline in mobility assessed by the Timed Up and Go (TUG) test
Time frame: Baseline, Week 4, and Week 8 (Primary comparison is the change from baseline to Week 4)
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.
7 secondary outcomes
Change from baseline in health-related quality of life assessed by the EORTC QLQ-C30
Time frame: Baseline, Week 4, and Week 8
Change from baseline in chemotherapy-induced peripheral neuropathy (CIPN) symptoms assessed by the EORTC QLQ-CIPN20
Time frame: 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)
Time frame: Baseline, Week 4, and Week 8
Change from baseline in fall risk assessed by the Fall Assessment Scale - Korean version (FAS-K)
Time frame: Baseline, Week 4, and Week 8
Change from baseline in walking endurance assessed by the 6-Minute Walk Test (6MWT)
Time frame: Baseline, Week 4, and Week 8
Change from baseline in handgrip strength
Time frame: Baseline, Week 4, and Week 8
Change from baseline in kinematic parameters of movement assessed by video-based motion analysis
Time frame: Baseline, Week 4, and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Chemotherapy-induced Peripheral Neuropathy (CIPN)
Not yet recruiting
Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Not yet recruiting
The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingPhase 2
Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
Chemotherapy-induced Peripheral Neuropathy, Chemotherapy-induced Neuropathic Pain
Not yet recruiting
AYUrvedic Foot Massage for Symtoms of Taxane-induced Peripheral nEuroPathy
Chemotherapy-induced Peripheral Neuropathy (CIPN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eun Joo Yang, MD, PhD study director
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReMap in people with Chemotherapy-induced Peripheral Neuropathy (CIPN), run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in mobility assessed by the Timed Up and Go (TUG) test (time frame: Baseline, Week 4, and Week 8 (Primary comparison is the change from baseline to Week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.