Otago Exercise Program in Chemotherapy Induced Peripheral Neuropathy

August 15, 2026 updated by: Merna Fawzy Fouad Reyad, Cairo University

Impact of Otago Exercise Program on Muscle Weakness in Patients With Chemotherapy Induced Peripheral Neuropathy

Forty-eight participants between the age of 35 to 55years patient treated with Taxane chemotherapy, will be randomly divided into two equal groups, each comprising 24 patients.

  • Group (A): Consists of twenty- four patients have chemo therapy Induced peripheral Neuropathy and will receive Otago exercise plus resistance exercise 3times per week for 8weeks
  • Group (B): Consists of twenty- four patients with Chemotherapy induced peripheral Neuropathy who will receive conventional physical therapy program including: resistance exercise for 8weeks , 3 times per week.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. Subject:

    Forty-eight participants between the age of 35 to 55years patient treated with Taxane chemotherapy, will be randomly divided into two equal groups, each comprising 24 patients.

    • forty-eight patient, will be assigned to two equal matched groups randomly:(twenty-four patient for each group)
    • Group (A): Consists of twenty- four patients have chemo therapy Induced peripheral Neuropathy and will receive Otago exercise plus resistance exercise 3times per week for 8weeks
    • Group (B): Consists of twenty- four patients with Chemotherapy induced peripheral Neuropathy who will receive conventional physical therapy program including: resistance exercise for 8weeks, 3 times per week.
  2. Equipments

(1)Therapeutic equipment and tools:

(1)(a)Otago Exercise Program: The session started with a moderate warm-up for joint mobility and flexibility, followed by strengthening exercises for the hips, knees and ankles. Balance activities, including walking and stance challenges, came next, and the session ended with a normal-paced walk and cool-down. All exercises were adapted to participants' ability levels.

  1. (b)- Therabands for resistance Elastic bands provide a safe and effective method for improving physical function and muscle strength. The findings highlight the importance of power-resistance training and improving quality of life. Elastic bands are emphasized as a low-cost, practical option for seniors to perform resistance training.
  2. Measurement procedure:

2-(a) Hand Held Dynamometer(HHD):

A Hand-Held Dynamometer (HHD) is a portable device used to measure muscle strength objectively. It measures the maximum force a muscle or muscle group can generate during an isometric contraction.It is commonly used in:

Physical therapy, Rehabilitation, Sports medicine and Clinical research.The examiner places the device against the patient's limb while the patient pushes as hard as possible against it. The device records the peak force produced by the muscle.Depending on the device, results may be displayed in:Newtons (N), Kilograms-force (kgf or kg) or Pounds-force (lbf or lb).

(2)(b)Modified Total Neuropathy Score (mTNS) is a clinical assessment tool used to evaluate the severity of peripheral neuropathy, particularly in patients with Chemotherapy-Induced Peripheral Neuropathy (CIPN). It is a modified version of the Total Neuropathy Score (TNS) that is simpler and more practical for clinical and research use because it does not require nerve conduction studies.The mTNS typically assesses: Sensory symptoms (e.g., numbness, tingling, pain),Motor symptoms (e.g., muscle weakness),Pin sensibility,Vibration sensibility,Muscle strength and deep tendon reflexes.Each item is scored from 0 (normal) to 4 (severe impairment).

Individual scores are added to obtain the total mTNS score.Higher scores indicate more severe peripheral neuropathy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Egypt
      • Giza, Egypt, Egypt, 12613
        • 1 Gamma street ,Giza, Egypt -postal code:12613

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 35-55 years. Patients undergoing taxane chemotherapy. Diagnosed with chemotherapy-induced peripheral neuropathy (CIPN). Able to understand and follow assessment and treatment instructions. Willing to provide written informed consent.

Exclusion Criteria:

  • Pre-existing neurological disorders (e.g., multiple sclerosis, stroke, or Parkinson's disease).

Symptomatic heart disease, including congestive heart failure, arrhythmia, or myocardial infarction within the previous 3 months.

Severe orthopedic conditions, fractures, or chronic debilitating diseases limiting participation in the exercise program.

Psychological, cognitive, or emotional disorders affecting participation. Uncooperative patients or those unable to follow the exercise protocol. Refusal or inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Otago Exercise Plus Resistance Exercise
Participants will receive the Otago Exercise Program in addition to resistance exercises using elastic bands, three sessions per week for 8 weeks.
Behavioral: Otago Exercise Program
An individualized Otago Exercise Program including warm-up, lower limb strengthening, balance, walking, and flexibility exercises. The program is delivered three times per week for 8 weeks under the supervision of a physical therapist.
Active Comparator: Resistance exercises
Participants will receive a conventional physical therapy program including resistance exercises with elastic bands, strengthening exercises, and lower limb exercises, three sessions per week for 8 weeks.
Behavioral: Resistance Exercise
resistance exercises with elastic bands, strengthening exercises, and lower limb exercises, three sessions per week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Muscle strength of the lower limb muscles will be assessed using a Hand-Held Dynamometer (HHD).
Time Frame: Baseline and after 8 weeks
Muscle strength of the lower limb muscles will be assessed using a Hand-Held Dynamometer (HHD).
Baseline and after 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Modified Total Neuropathy Score (mTNS)
Time Frame: Baseline and after 8 weeks
Chemotherapy-induced peripheral neuropathy severity will be assessed using the Modified Total Neuropathy Score (mTNS).
Baseline and after 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cairo University, Faculty of Physical Therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OTAGO-CIPN-P.T.REC/012/006339

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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