Sensory Rehabilitation in Chemotherapy Induced Peripheral Neuropathy (CIPN)

Not Applicable

Recruiting

• Conditions: CIPN
• Interventions: Diagnostic Test: Questionares and practice

• Registration Number: NCT05382520
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-16
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-19
• Study Start: 2022-08-01
• Status Verified: 2024-01
• Primary Completion: 2024-01-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Explicit sensory retraining for lower extremity in individuals with CIPN	Questionares and practice	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.

Primary Outcome Measures

Name	Time	Method
FABS	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.
LEPT	2 years	Lower Extremity Position Test: proprioception detection and quantification
TNAS	2 years	TNAS -Treatment-Induced Neuropathy Assessment Scale. 0-90. higher score = worse status
VAS	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.
Allodynia	2 years	tested by non-painful mechanical stimulation: gentle brushing and monofilament
NSA	2 years	Nottingham Sensory Assessment: sensory detection and discrimination test
Semmes-Weinstein monofilament testing	2 years	tactile detection threshold
TUG	2 years	Timed Up and Go: fall prediction screening test; measures time taken to raise from a chair walking 3 meters and re-sit.

Trial Locations

Locations (1)

Shamir medical center; 🇮🇱 Beer Yaaqov, Israel