An interventional study of Explicit Sensory Retraining for the lower extremities and no treatment in CIPN - Chemotherapy-Induced Peripheral Neuropathy, Age Over 18 and Chemotherapy-induced Peripheral Neuropathy, sponsored by Assaf-Harofeh Medical Center. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Assaf-Harofeh Medical Center · Not applicable, Interventional, and Treatment
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.
Chemotherapy Induced Peripheral Neuropathy (CIPN) is a neurological complication of chemotherapy, affecting between 50%-90% of the patients: up to 68% within the first month after chemotherapy, 60% after 3 months, and 30% after 6 months.
Neuropathic symptoms can persist in 11% to more than 80% of individuals post chemotherapy at one to three years following treatment and around 50% even after 5 years and more.
CIPN is associated with lower self-reported physical function and Quality of Life (QoL).
The clinical picture is typically sensory, with involvement of large and small sensory fibers. Motor and autonomic involvement is less frequent.
Damage to sensory nerve fibers is typically symmetrical. Sensory loss in a 'glove and stocking type' distribution leads to 'minus' symptoms (loss of function) including numbness in hands and feet, impaired perception of light touch, hypoalgesia and impaired proprioception, temperature and vibration sensation. Paradoxically, 'plus' features (gain of function) such as paresthesia (tingling like pins and needles), dysesthesia, allodynia and hyperalgesia appear simultaneously. CIPN can be functionally debilitating including impaired balance, walking slower and shorter steps and increased falls.
Active, explicit sensory rehabilitation is efficient in promoting sensation and function in individuals with neurological conditions, such as stroke and multiple sclerosis. To the best of our knowledge although CIPN is primarily a sensory deficit there is no treatment aimed at this aspect. We aim to conduct a pilot study to explore the feasibility and clinical benefit of an active, explicit sensory rehabilitation protocol for the lower limb in individuals with chronic CIPN.
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.
Exclusion Criteria:
AB - early experimental treatment, later control usual care
Other: Explicit Sensory Retraining for the lower extremities · Other: no treatment
BA - early control usual care, later experimental treatment
Other: Explicit Sensory Retraining for the lower extremities · Other: no treatment
Sensory 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.
Usual 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.
Time frame: from randomization 3 months maximum
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.
Time frame: from randomization to maximum 3 months followup
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
Time frame: from randomization to maximum 3 months
Tactile function assessment - Semmes Weinstein Monofilaments (SWM)
Sensory threshold at the foot, as measured by Semmes Weinstein filaments.
Time frame: from randomization to maximum 3 months followup
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.
Time frame: from randomization to maximum 3 months
Proprioception of lower extremity: Lower Extremity Position Test (LEPT)
Proprioception of lower extremity as measured by Lower Extremity Position Test (LEPT).
Time frame: from randomization to maximum 3 months followup
Home exercise log
Amount of home exercise per minutes per day
Time frame: 1 minutes writing daily at home
Participant satisfaction questionnaire
Participant satisfaction questionnaire
Time frame: 5 minutes, at final assessment session only
Plan to share: Undecided
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Assaf-Harofeh Medical Center