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Completed

NCT Number: NCT07773922

Otago Exercise Program in 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.

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Key information

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Giza, Egypt, 12613

About this study

  • 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.
  • 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.

  • (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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Otago Exercise Program

Behavioral

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.

Resistance exercise

Behavioral

resistance exercises with elastic bands, strengthening exercises, and lower limb exercises, three sessions per week for 8 weeks.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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