Sensory Rehabilitation in Chemotherapy Induced Peripheral Neuropathy (CIPN)

NCT05382520 | Unknown

• 1 other identifier: 0057-22-ASF
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Physiotherapist research about Sensory rehabilitation in chemotherapy induced peripheral neuropathy (CIPN) with the aid of questioners and physiotherapy practice

Conditions

CIPN

Keywords

Neuropathic pain; Chemo Induced Peripheral Neuropathy (CIPN); Sensory rehabilitation; Explicit Sensory Retraining

Outcome Measures

Primary Outcomes (8)

• TNAS

  TNAS -Treatment-Induced Neuropathy Assessment Scale. 0-90. higher score = worse status

  2 years

• VAS

  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

  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

  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

  Nottingham Sensory Assessment: sensory detection and discrimination test

  2 years

• Semmes-Weinstein monofilament testing

  tactile detection threshold

  2 years

• LEPT

  Lower Extremity Position Test: proprioception detection and quantification

  2 years

• Allodynia

  tested by non-painful mechanical stimulation: gentle brushing and monofilament

  2 years

Study Arms (1)

Explicit sensory retraining for lower extremity in individuals with CIPN

EXPERIMENTAL

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

Interventions

Questionares and practice DIAGNOSTIC_TEST

Questionares and practice

Explicit sensory retraining for lower extremity in individuals with CIPN

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead
• Zefat Academic College: collaborator

Study Sites (1)

Shamir medical center

Beer Yaaqov, Israel

RECRUITING

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rotem Merose, Dr.

  Assaf Harofee MC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hadas Ofek

CONTACT

972544666412; hadasbarkolofek@gmail.com

Nicole Asraf

CONTACT

972544699403; nicoleas000@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Breast Oncologist

Model Details: Prospective Pilot and Feasibility study

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: August 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: December 1, 2025
• Last Updated: January 12, 2024

Record last verified: 2024-01

Locations

IL (1)