Sensory Rehabilitation in Chemo Induced Peripheral Neuropathy
NCT ID: NCT06724861
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
27 participants
INTERVENTIONAL
2024-12-11
2026-12-11
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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AB - early experimental treatment, later control usual care
AB - early experimental treatment, later control usual care
Explicit Sensory Retraining for the lower extremities
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.
no treatment
Usual care
BA - early control usual care, later experimental treatment
BA - early control usual care, later experimental treatment
Explicit Sensory Retraining for the lower extremities
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.
no treatment
Usual care
Interventions
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Explicit Sensory Retraining for the lower extremities
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.
no treatment
Usual care
Eligibility Criteria
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Inclusion Criteria
* age \> 18.
Exclusion Criteria
* recurrent falls prior to chemotherapy (more than 2 per year)
* CNS involvement
* not ambulatory before chemotherapy
* Hebrew proficiency not meeting questionnaires' needs.
18 Years
ALL
No
Sponsors
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Zefat Academic College
OTHER
Assaf-Harofeh Medical Center
OTHER_GOV
Responsible Party
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Rotem Merose
MD
Locations
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Asaph-Harofe Shamir Medical Center
Rishon LeZiyyon, , Israel
Countries
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Central Contacts
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Other Identifiers
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CIPN - RCT
Identifier Type: -
Identifier Source: org_study_id