Effects of Galileo® vibration exercise in addition to care-related exercise according to the Viv-Arte® nursing conception on motor control, motor function, motor action and muscular strength in patients with chemotherapy-related polyneuropathy [Auswirkungen des Galileo®-Vibrationstrainings als Zusatz zum pflegerischen Trainingskonzept des Viv?Arte® Modells auf Bewegungssteuerung, Alltagsbewegungen, Alltagshandlungen und Muskelkraft bei Chemotherapie-Induzierter Polyneuropathie]

Effects of whole-body vibration exercise in addition to care-related exercise according to the Viv-Arte® nursing conception on motor control, motor function and muscular strength: a randomised controlled trial in chemotherapy-related polyneuropathy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN51361937

Enrollment

122

Registered

2010-09-06

Start date

2010-07-01

Completion date

Unknown

Last updated

2017-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polyneuropathies, secondary to haematologic neoplasms and chemotherapy Cancer Other polyneuropathies

Interventions

Control group and experimental group: 15 sessions (two per week) of 60 minutes each, containing VAT manual therapy and functional training. The latter will be skipped for patients who are not reliant

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 70 years 2. Polyneuropathy diagnosed (MeSH D011115) 3. Ongoing or finished chemotherapy due to hematologic neoplasms (MeSH D019337) 4. Contiguity between polyneuropathy and chemotherapy supposable 5. Chair Rising Test with pathological score (> 10 s) 6. Informed consent

Exclusion criteria

Exclusion criteria: 1. Blood coagulation disorder 2. Infection beyond control 3. Thrombosis within 6 months before the trial 4. Severe neurological or psychiatric disorder, which might impair the validity of informed consent or the compliance with trial interventions 5. Epilepsy 6. Pregnacy

Design outcomes

Primary

Measure	Time frame
Chair Rising Test (5 times standing up from a chair) at baseline, 8th exercise session, 15th (last) exercise session, and 4 weeks after last exercise session	—

Secondary

Measure	Time frame
1. Bipedal jump test and balance test using a force plate (Leonardo® Mechanography) at baseline, 15th (last) exercise session, and 4 weeks after last exercise session 2. Functional mobility measured using motor tests including the Timed up and go test (TUG) and the Mobility test for patients in acute care (MOTPA) at baseline and 15th (last) exercise session 3. Quality of life, measured using the EORTC Quality of Life Core Questionnaire (QLQ-C30), Version 3.0, at baseline, 15th (last) exercise session, and 4 weeks after last exercise session 4. Neurotoxicity, measured using the FACT/GOG Ntx (Funktional Assessment of Cancer Therapy/Gynecologie Onkcology Group - Neurotoxity) at baseline, 8th exercise session, 15th (last) exercise session, and 4 weeks after last exercise session 5. Paresthesia, measured using the Visual Analogue Scale (VAS) at baseline, 15th (last) exercise session, and 4 weeks after last exercise session 6. Sensory function, measured at baseline and 15th (last) exercise session, using a standardized quantitative sensory testing (QST) battery: 6.1. Thermal detection threshold, using a computer controlled thermode 6.2. Tactile detection threshold, using von-Frey hairs 6.3. Mechanical pain threshold/sensitivity for pinprick and for light touch, including wind-up (series) sensitivity 6.4. Vibration detection threshold, using a tuning fork 6.5. Pressure pain threshold, using a pressure algometer 7. In order to estimate velocity of nerve conduction as well as sensory and motor evoked potentials (SNAP, MEP), additional electrophysiological measurements will be taken on the discretion of the neurologist	—

Measure

Time frame

1. Bipedal jump test and balance test using a force plate (Leonardo® Mechanography) at baseline, 15th (last) exercise session, and 4 weeks after last exercise session 2. Functional mobility measured using motor tests including the Timed up and go test (TUG) and the Mobility test for patients in acute care (MOTPA) at baseline and 15th (last) exercise session 3. Quality of life, measured using the EORTC Quality of Life Core Questionnaire (QLQ-C30), Version 3.0, at baseline, 15th (last) exercise session, and 4 weeks after last exercise session 4. Neurotoxicity, measured using the FACT/GOG Ntx (Funktional Assessment of Cancer Therapy/Gynecologie Onkcology Group - Neurotoxity) at baseline, 8th exercise session, 15th (last) exercise session, and 4 weeks after last exercise session 5. Paresthesia, measured using the Visual Analogue Scale (VAS) at baseline, 15th (last) exercise session, and 4 weeks after last exercise session 6. Sensory function, measured at baseline and 15th (last) exercise session, using a standardized quantitative sensory testing (QST) battery: 6.1. Thermal detection threshold, using a computer controlled thermode 6.2. Tactile detection threshold, using von-Frey hairs 6.3. Mechanical pain threshold/sensitivity for pinprick and for light touch, including wind-up (series) sensitivity 6.4. Vibration detection threshold, using a tuning fork 6.5. Pressure pain threshold, using a pressure algometer 7. In order to estimate velocity of nerve conduction as well as sensory and motor evoked potentials (SNAP, MEP), additional electrophysiological measurements will be taken on the discretion of the neurologist

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026