This study is a cross-over RCT evaluating the effectiveness of 3 sessions a week apart of explicit sensory retraining to the lower extremities in individuals with CIPN versus usual care. The primary outcome measures are TNAS for subjective symptoms, VAS for pain and TUG for mobility. Additional outcome measures are FABS for balance, sensory assessments - monofilaments for touch threshold, LEPT for proprioception, a home exercise log and a satisfaction questionnaire.
CIPN by self-report (present or absent) > 3 months after last chemotherapy treatment
age > 18.
Pre-chemotherapy neuropathy/ sensory impairment
recurrent falls prior to chemotherapy (more than 2 per year)
CNS involvement
not ambulatory before chemotherapy
Crossover
Explicit Sensory Retraining for the lower extremities
Other interventionSensory retraining of detection, discrimination, quantification of a stimuli and recognition of stimuli and objects with the leg and mainly with the foot. Top-down awareness of bottom-up sensory experience in the treatment session and in everyday life.
no treatment
Other interventionUsual care
Patient self-Report Outcome Measure - Treatment-Induced Neuropathy Assessment Scale (TNAS)
TNAS -Treatment-Induced Neuropathy Assessment Scale: patient-reported outcome measure of presence and severity of CIPN. Nine 0-10 question scale. score 0-90. A higher score is for higher CIPN symptom severity.
Functional - Balance and mobility outcome measure - Timed Up and Go test (TUG)
TUG -Timed Up and Go: Balance and mobility assessment. Serves as a fall prediction screening test. Measures time taken to raise from a chair walking 3 meters and re-sit.
Pain intensity: VAS - 0-100 mm visual scale
Pain intensity: 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
Tactile function assessment - Semmes Weinstein Monofilaments (SWM)
Sensory threshold at the foot, as measured by Semmes Weinstein filaments.
FABS - Fullerton Advanced Balance Scale
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.
Proprioception of lower extremity: Lower Extremity Position Test (LEPT)
Proprioception of lower extremity as measured by Lower Extremity Position Test (LEPT).
Home exercise log
Amount of home exercise per minutes per day
Participant satisfaction questionnaire
Participant satisfaction questionnaire
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Assaf-Harofeh Medical Center
Lead sponsor
Zefat Academic College
Collaborator
