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

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

Overview

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.

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.

Interventions

• Other Feedback-Based Balance and Gait Training
  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 interv
• Other 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.

Primary outcome measures

• Balance Performance [Time frame: Baseline and immediately after completion of the 4-week intervention]

Secondary outcome measures (2)

• Gait Performance [Time frame: Baseline and immediately after completion of the 4-week intervention]
• Chemotherapy-Induced Peripheral Neuropathy Symptoms [Time frame: Baseline and immediately after completion of the 4-week intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• King Edward Medical University, Lahore — Lahore

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. PMID 16267188
• Staff 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. PMID 28486769
• Berg 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. PMID 1468055

Identifiers

NCT: NCT07368439 · 66/RC/KEMU

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗