An interventional study of Feedback-Based Balance and Gait Training and Conventional Physiotherapy in Chemotherapy Induced Peripheral Neuropathy (CIPN), sponsored by King Edward Medical University. Not yet recruiting at 1 site in Pakistan. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by King Edward Medical University · Not applicable, Interventional, and Treatment
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.
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.
King Edward Medical University is the lead sponsor of 78 studies on the registry; 24 are open to participants now.
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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
Exclusion Criteria:
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
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.
Other: Feedback-Based Balance and Gait Training
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.
Other: Conventional Physiotherapy
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 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.
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.
Time frame: Baseline and immediately after completion of the 4-week intervention
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.
Time frame: 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
Time frame: Baseline and immediately after completion of the 4-week intervention
Plan to share: 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.
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King Edward Medical University