Effect of Feedback-Based Balance Training on Balance and Gait in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy

King Edward Medical University

Status: Not yet enrolling

Conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN)

Treatments: Other: Feedback-Based Balance and Gait Training; Other: Conventional Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07368439

66/RC/KEMU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Feedback-Based Balance Training Plus Conventional Physiotherapy

Experimental group

Description:

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.

Treatment:

Other: Feedback-Based Balance and Gait Training

Conventional Physiotherapy

Active Comparator group

Description:

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.

Treatment:

Other: Conventional Physiotherapy