Chemotherapy Induced Peripheral Neuropathy (CIPN)NCT07368439
Effect of Feedback-Based Balance Training on Balance and Gait in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy
A study testing Feedback-Based Balance and Gait Training and Conventional Physiotherapy in people with Chemotherapy Induced Peripheral Neuropathy (CIPN), run by King Edward Medical University at 1 site in Pakistan.
Trial summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a common complication of cancer treatment that can cause numbness, tingling, pain, balance problems, and difficulty walking. These symptoms may increase the risk of falls and reduce independence and quality of life in cancer survivors. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Chemotherapy Induced Peripheral Neuropathy (CIPN)
- What is being tested?
- Feedback-Based Balance and Gait Training and Conventional Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Jan 2026to 29 Apr 2026
- Phase
- Interventional
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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 30 to 60 years
- Diagnosed with breast, rectal, or stomach cancer
- History of treatment with neurotoxic chemotherapy
- Presence of chemotherapy-induced peripheral neuropathy as indicated by an EORTC CIPN20 total score of 24 or higher
- Ability to walk independently for at least 6 meters, with or without an assistive device
- Medically stable and able to participate in physiotherapy
Who cannot join
- Peripheral neuropathy due to causes other than chemotherapy (e.g., diabetes mellitus)
- History of neurological disorders affecting balance or gait (e.g., stroke, Parkinson's disease)
- Severe musculoskeletal conditions affecting balance or lower limb function
- Active foot ulcers, infections, or soft tissue injuries
- Severe visual impairment affecting balance
- Any medical condition that, in the investigator's judgment, would interfere with safe participation
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
King Edward Medical University, Lahore
Lahore, Punjab Province
About this study
Official title: Effects of Feedback-Based Balance Training on Balance and Gait Performance in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN): A Randomized Controlled Trial
Chemotherapy-induced peripheral neuropathy (CIPN) is a common complication of cancer treatment that can cause numbness, tingling, pain, balance problems, and difficulty walking. These symptoms may increase the risk of falls and reduce independence and quality of life in cancer survivors.
The purpose of this study is to determine whether adding feedback-based balance training to conventional physiotherapy improves balance and walking ability in cancer patients with CIPN. Participants will be randomly assigned to one of two groups. One group will receive conventional physiotherapy along with feedback-based balance and gait training, while the other group will receive conventional physiotherapy alone.
The intervention will be provided twice per week for four weeks. Balance, gait performance, neuropathy symptoms, and fear of falling will be assessed before and after the intervention using standardized clinical outcome measures. The findings of this study may help identify effective rehabilitation strategies to improve balance and mobility in cancer patients affected by chemotherapy-induced peripheral neuropathy.
Read the detailed description
This study is a single-blind, parallel-group randomized controlled trial designed to evaluate the effects of feedback-based balance training on balance and gait performance in cancer patients with chemotherapy-induced peripheral neuropathy (CIPN).
Eligible participants will be adults aged 30 to 60 years with a diagnosis of breast, rectal, or stomach cancer who have developed peripheral neuropathy following neurotoxic chemotherapy. Participants must be able to walk at least six meters independently and demonstrate clinically relevant neuropathy symptoms as measured by the EORTC CIPN20 questionnaire. Individuals with other causes of peripheral neuropathy, significant neurological disorders, severe visual impairment, or musculoskeletal conditions affecting balance will be excluded.
A total of 70 participants will be recruited and randomly allocated into two groups in a 1:1 ratio. The experimental group will receive conventional physiotherapy combined with feedback-based balance and gait training, while the control group will receive conventional physiotherapy alone. Randomization will be performed using a simple random allocation method. Outcome assessors will be blinded to group allocation.
The intervention will be delivered twice weekly for four weeks, with each session lasting approximately 30 minutes. Feedback-based balance training will include task-oriented balance and gait activities incorporating visual and verbal feedback, mirror-based exercises, and functional gait tasks designed to challenge postural control and coordination. Conventional physiotherapy will include strengthening, flexibility, and general balance exercises.
Outcome measures will be assessed at baseline and immediately after completion of the four-week intervention. Primary outcomes include balance performance measured using the Berg Balance Scale and gait performance measured by walking speed. Secondary outcomes include neuropathy-related symptoms assessed using the EORTC CIPN20 questionnaire and fear of falling assessed using the Falls Efficacy Scale-International (FES-I).
This study aims to provide evidence on the effectiveness of feedback-based balance training as an adjunct to conventional physiotherapy for improving balance, gait, and functional confidence in cancer patients with chemotherapy-induced peripheral neuropathy.
- Being tested
- Feedback-Based Balance and Gait Training, Conventional Physiotherapy
- Keywords
- Chemotherapy-Induced Peripheral Neuropathy, Balance Training, Feedback-Based Training, Gait Training, Physiotherapy, Cancer Rehabilitation, Fall Prevention, Postural Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback-Based Balance and Gait TrainingOther
Feedback-based balance and gait training will include structured, task-oriented balance and walking activities designed to challenge postural control and coordination. The intervention will incorporate visual and verbal feedback provided by the therapist, mirror-based exercises, and functional gait tasks such as obstacle negotiation and controlled walking activities. Training will be supervised and delivered in sessions lasting approximately 30 minutes, twice per week for four weeks. This intervention will be provided in addition to conventional physiotherapy.
Conventional PhysiotherapyOther
Conventional physiotherapy will include standard rehabilitation exercises commonly used for patients with peripheral neuropathy, such as strengthening exercises, flexibility exercises, and general balance training. Sessions will be supervised by a physiotherapist and delivered for approximately 30 minutes per session, twice per week for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Feedback-Based Balance Training Plus Conventional Physiotherapy | Experimental | Participants in this arm will receive conventional physiotherapy combined with feedback-based balance and gait training. Conventional physiotherapy will include strengthening, flexibility, and general balance exercises. Feedback-based balance training will consist of task-oriented balance and gait activities incorporating visual and verbal feedback, mirror-based exercises, and functional gait tasks designed to challenge postural control and coordination. Sessions will be supervised, last approximately 30 minutes, and will be conducted twice per week for four weeks. Receives: Other: Feedback-Based Balance and Gait Training |
| Conventional Physiotherapy | Active comparator | Participants in this arm will receive conventional physiotherapy focused on strengthening, flexibility, and general balance exercises commonly used in the rehabilitation of patients with peripheral neuropathy. Sessions will be supervised, last approximately 30 minutes, and will be conducted twice per week for four weeks. Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Performance
Balance performance will be evaluated using the Berg Balance Scale (BBS), a 14-item standardized clinical assessment with total scores ranging from 0 to 56, where higher scores indicate better balance.
Measured: Baseline and immediately after completion of the 4-week intervention
Secondary outcomes (2)
Gait Performance
Gait performance will be assessed by measuring walking speed over a standardized 6-meter walking distance. Walking speed will be calculated in meters per second, with higher values indicating better gait performance.
Measured: Baseline and immediately after completion of the 4-week intervention
Chemotherapy-Induced Peripheral Neuropathy Symptoms
Severity of chemotherapy-induced peripheral neuropathy symptoms will be assessed using the European Organisation for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy questionnaire (EORTC CIPN20). Higher scores indicate greater severity of neuropathy-related symptoms
Measured: Baseline and immediately after completion of the 4-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start29 Jan 2026
- Primary completion29 Mar 2026
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy Induced Peripheral Neuropathy (CIPN)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either an experimental group receiving feedback-based balance training in addition to conventional physiotherapy or a control group receiving conventional physiotherapy alone.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amna Zia, King Edward Medical University
- Investigators
- Amna Zia, PhD. Scholar, Principal investigator, King Edward Medical University, LahoreMuhammad Saad Khalid, Principal investigator, King Edward Medical University, LahoreRizwan Haider, PhD. Scholar, Study director, King Edward Medical University, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368439
- Sponsor's protocol ID
- 66/RC/KEMU
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly due to the single-center nature of the study, institutional data protection policies, and the absence of participant consent for public data sharing. De-identified, aggregated results will be reported in publications and presentations.
Publications
Yardley L, Beyer N, Hauer K, Kempen G, Piot-Ziegler C, Todd C. Development and initial validation of the Falls Efficacy Scale-International (FES-I). Age Ageing. 2005 Nov;34(6):614-9. doi: 10.1093/ageing/afi196.
PubMed 16267188Staff NP, Grisold A, Grisold W, Windebank AJ. Chemotherapy-induced peripheral neuropathy: A current review. Ann Neurol. 2017 Jun;81(6):772-781. doi: 10.1002/ana.24951. Epub 2017 Jun 5.
PubMed 28486769Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11.
PubMed 1468055