Task-oriented Training on Hand Function in Taxanes-induced Peripheral Neuropathy

October 16, 2024 updated by: Arwa Reda Hashem, Cairo University

Task-oriented Training on Hand Function in Patients With Taxanes-induced Peripheral Neuropathy

Chemotherapy based on taxanes is commonly used to treat breast cancer. However, chemotherapy-induced peripheral neuropathy (CIPN), a side effect of taxanes, impairs a patient's grip strength, hand dexterity, and upper extremity function which affects quality of life (QOL).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Task-oriented training, a type of exercise where exercises are organized into tasks, concentrates on enhancing particular functional abilities through useful, goal-directed activities. So, the purpose of the study to explore the effectiveness of task-oriented training (TOT) on grip strength, hand dexterity and upper extremity function in patients with taxanes-induced peripheral neuropathy.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • 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
      • Giza, Egypt, 11432
        • Faculty of physical therapy, Cairo University

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients were females only.
  • Their ages range from 35 to 65.
  • All patients suffered from CIPN after using taxanes (anti-cancer agent causing neurotoxic effect).
  • Diagnosis of CIPN was determined based on symptom history or the presence of stocking glove pattern "distal dysesthesias, pain and numbness" beginning after taxanes intake.
  • All patients enrolled to the study had their informed consent.
  • Patients suffer from affected brachial plexus.

Exclusion Criteria:

  • Patients had pain or numbness in the upper extremity due to other reasons like trauma (fracture), CNS diseases (cerebral infarction), other diseases with neurological symptoms like (diabetes, rheumatoid arthritis or cervical myelopathy).
  • Patients had bone, brain or spinal cord metastases.
  • Patients who had history of psychiatric disorders like: depression and schizophrenia or cognitive decline that may hinder them from active participation in the study.
  • Patients exhibited only acute neuropathy like in patients using oxaliplatin.

Exclusion Criteria:

  • Patients had pain or numbness in the upper extremity due to other reasons like trauma (fracture), CNS diseases (cerebral infarction), other diseases with neurological symptoms like (diabetes, rheumatoid arthritis or cervical myelopathy).
  • Patients had bone, brain or spinal cord metastases.
  • Patients who had history of psychiatric disorders like: depression and schizophrenia or cognitive decline that may hinder them from active participation in the study.
  • Patients exhibited only acute neuropathy like in patients using oxaliplatin

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Task oriented training group
This group included 30 patients suffering from taxanes induced peripheral neuropathy who received 30 minutes of task-oriented exercises, three sessions per week for four weeks along with 30 minutes of the traditional physical therapy.
Other: Task oriented training exercises
Task oriented training is a type of exercises in form of tasks using papers, pens, scissors, clips, coins, screws and clay
Other: Traditional physical therapy
Traditional physical therapy inform of mobilization, strengthening exercises of hand and streching exercises.
Active Comparator: Traditional physical therapy group
This group included 30 patients suffering from taxanes induced peripheral neuropathy who received 30 minutes of the traditional physical therapy only, three sessions per week for four weeks.
Other: Traditional physical therapy
Traditional physical therapy inform of mobilization, strengthening exercises of hand and streching exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand grip strength
Time Frame: At baseline and after four weeks of intervention.
Hand grip strength (HGS) was measured in the dominant hand for each patient using The CAMRY dynamometer
At baseline and after four weeks of intervention.
Hand dexterity
Time Frame: At baseline and after four weeks of intervention.
The nine-hole peg test was used to assess the hand dexterity
At baseline and after four weeks of intervention.
Hand function
Time Frame: At baseline and after four weeks of intervention.
Each patient was asked to answer the questions of the six scales in the Arabic version of Michigan hand questionnaire (1- Overall hand function, 2-Activities of Daily Living, 3- Work performance, 4- Pain, 5- Aesthetics, and 6- Satisfaction with hand function)
At baseline and after four weeks of intervention.

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Shaimaa M A Elsayeh, PhD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2023

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 9, 2024

Study Record Updates

Last Update Posted (Actual)

October 18, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/00460

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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