- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07368439
Effect of Feedback-Based Balance Training on Balance and Gait in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amna Zia, PhD. Scholar
- Phone Number: +92 324 4686993
- Email: amna.zia@kemu.edu.pk
Study Contact Backup
- Name: Muhammad Saad Khalid, DPT
- Phone Number: +92 335 4337441
- Email: m.saad.khalid.sk@gmail.com
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan
- King Edward Medical University, Lahore
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Contact:
- Prof. Muhammad Imran
- Phone Number: +92 42 99214819
- Email: registrar@kemu.edu.pk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Feedback-Based Balance Training Plus Conventional Physiotherapy
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.
|
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.
|
|
Active Comparator: Conventional Physiotherapy
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance Performance
Time Frame: Baseline and immediately after completion of the 4-week intervention
|
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.
|
Baseline and immediately after completion of the 4-week intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait Performance
Time Frame: Baseline and immediately after completion of the 4-week intervention
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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.
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Baseline and immediately after completion of the 4-week intervention
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Chemotherapy-Induced Peripheral Neuropathy Symptoms
Time Frame: Baseline and immediately after completion of the 4-week intervention
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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
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Baseline and immediately after completion of the 4-week intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amna Zia, PhD. Scholar, King Edward Medical University, Lahore
- Principal Investigator: Muhammad Saad Khalid, King Edward Medical University, Lahore
- Study Director: Rizwan Haider, PhD. Scholar, King Edward Medical University, Lahore
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 66/RC/KEMU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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