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Patients With Chemotherapy-induced Polyneuropathy Are Treated With an Integrated Program Including Massage, Mobilization in Posture and Transport Layers, Physical Exercises or With Whole-body Vibration Platform Training

U

University of Ulm

Status

Completed

Conditions

Polyneuropathy

Study type

Observational

Funder types

Other

Identifiers

NCT02846844
PI-PNP - _01_10

Details and patient eligibility

About

In a Phase-III Study Patients With Chemotherapy-induced Polyneuropathy (NCI CTC Grade 2/3) Are Randomized for an Integrated Program (IP) Including Massage, Mobilization in Posture and Transport Layers, Physical Exercises (Standard) or With Whole-body Vibration (WBV) Platform Training (Experimental).

Full description

Subjects with a haematological malignancy or solid and a diagnosis of a chemotherapy-induced polyneuropathy. In a phase-III study patients with chemotherapy-induced polyneuropathy (NCI CTC grade 2/3) are randomized for an integrated program (IP) including massage, mobilization in posture and transport layers, physical exercises (standard) or with whole-body vibration (WBV) platform training (experimental). 15 training sessions in a time period of 12 to 15 weeks were intended. Evaluation included locomotor and neurological tests and self-assessment-tools. The primary objective of the study was the physical fitness and coordination assessed by the chair-rising test (CRT).

Enrollment

122 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients 18 to 70 years of age with solid and hematological neoplasms suffering from chemotherapy-induced polyneuropathy grade II-III according to National Cancer Institute Common Toxicity Criteria (NCI CTC, version 3.0) and pathological chair-rising test (CRT)28 ( ≥10 s) were eligible

Exclusion criteria

  • psychiatric disorders
  • plasmatic coagulation disorders
  • thrombotic/thromboembolic events within 6 months before randomization
  • severe neurological disorders like seizures

Trial design

122 participants in 2 patient groups

Group A
Description:
* Whole body vibration training * manuelle therapy * exercises for power and coordination * performance training as needed
Group B
Description:
* manuelle therapy * Exercises for power and coordination * Performance training as needed

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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