Sensory Rehabilitation in Chemotherapy Induced Peripheral Neuropathy (CIPN)

January 10, 2024 updated by: Rotem Merose, Assaf-Harofeh Medical Center
Physiotherapist research about Sensory rehabilitation in chemotherapy induced peripheral neuropathy (CIPN) with the aid of questioners and physiotherapy practice

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

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 Contact

Study Contact Backup

Study Locations

  • Israel
      • Beer Yaaqov, Israel
        • Recruiting
        • Shamir Medical Center
        • Contact:
          • Nicole Asaraf
          • Phone Number: 972-544699403
        • Principal Investigator:
          • Rotem Maroz, Dr.

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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

Patients aged 18 and over who suffer from chemotherapy-induced neuropathy (CIPN),

Description

Inclusion Criteria:

  • Patients aged 18 and over who suffer from chemotherapy-induced neuropathy (CIPN), according to the patient's report, more than 3 months since the end of the chemotherapy treatment.

Exclusion Criteria:

  1. Sensory damage / neuropathy that existed even before the start of chemotherapy
  2. Incidents of recurrent falls even before the start of chemotherapy (over 2 falls for 6 months)
  3. Central nervous system involvement
  4. Major pre-morbid orthopedic lower limb impairment
  5. Hebrew language not sufficient for assessment and treatment

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Explicit sensory retraining for lower extremity in individuals with CIPN
Explicit sensory retraining for lower extremity function (pain, sensory, balance, gait). five one-hour sessions, a week apart: Pre-Post assessment sessions with 3 treatment sessions in between. Home exercise assigned.
Diagnostic test: Questionares and practice
Questionares and practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS
Time Frame: 2 years
0-100 mm visual scale: self-reporting pain assessment from no pain to worst pain possible. We will ask for current pain and the worst pain during the last week.
2 years
FABS
Time Frame: 2 years
Fullerton Advanced Balance Scale: high function balance test - consisting of 10 activities in both static and dynamic phases; 10-40, higher scores are better.
2 years
TUG
Time Frame: 2 years
Timed Up and Go: fall prediction screening test; measures time taken to raise from a chair walking 3 meters and re-sit.
2 years
NSA
Time Frame: 2 years
Nottingham Sensory Assessment: sensory detection and discrimination test
2 years
Semmes-Weinstein monofilament testing
Time Frame: 2 years
tactile detection threshold
2 years
LEPT
Time Frame: 2 years
Lower Extremity Position Test: proprioception detection and quantification
2 years
Allodynia
Time Frame: 2 years
tested by non-painful mechanical stimulation: gentle brushing and monofilament
2 years
TNAS
Time Frame: 2 years
TNAS -Treatment-Induced Neuropathy Assessment Scale. 0-90. higher score = worse status
2 years

Collaborators and Investigators

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

Sponsor

Assaf-Harofeh Medical Center

Collaborators

Zefat Academic College

Investigators

  • Principal Investigator: Rotem Merose, Dr., Assaf Harofee MC

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)

August 1, 2022

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 16, 2022

First Submitted That Met QC Criteria

May 16, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0057-22-ASF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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