NCT07368439

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 29, 2025

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2026

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 18, 2026

Last Update Submit

January 18, 2026

Conditions

Keywords

Chemotherapy-Induced Peripheral NeuropathyBalance TrainingFeedback-Based TrainingGait TrainingPhysiotherapyCancer RehabilitationFall PreventionPostural Control

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and immediately after completion of the 4-week intervention

Secondary Outcomes (2)

  • Gait Performance

    Baseline and immediately after completion of the 4-week intervention

  • Chemotherapy-Induced Peripheral Neuropathy Symptoms

    Baseline and immediately after completion of the 4-week intervention

Study Arms (2)

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.

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.

Other: Conventional Physiotherapy

Interventions

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.

Feedback-Based Balance Training Plus 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.

Conventional Physiotherapy

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Edward Medical University, Lahore

Lahore, Punjab Province, Pakistan

Location

Related Publications (3)

  • 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: 16267188BACKGROUND
  • 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: 28486769BACKGROUND
  • 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: 1468055BACKGROUND

Study Officials

  • Amna Zia, PhD. Scholar

    King Edward Medical University, Lahore

    PRINCIPAL INVESTIGATOR
  • Muhammad Saad Khalid

    King Edward Medical University, Lahore

    PRINCIPAL INVESTIGATOR
  • Rizwan Haider, PhD. Scholar

    King Edward Medical University, Lahore

    STUDY DIRECTOR

Central Study Contacts

Amna Zia, PhD. Scholar

CONTACT

Muhammad Saad Khalid, DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be blinded to group allocation by providing both groups with supervised physiotherapy sessions of similar duration and structure, without disclosure of group-specific intervention details. Outcome assessors will be blinded to treatment allocation. Due to the nature of the intervention, care providers delivering the physiotherapy cannot be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist/ Lecturer

Study Record Dates

First Submitted

January 18, 2026

First Posted

January 26, 2026

Study Start

December 29, 2025

Primary Completion

March 29, 2026

Study Completion

April 29, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations