Vojta Therapy in Early Stroke Rehabilitation
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ClinicalTrials.gov Identifier: NCT03035968 |
Recruitment Status :
Completed
First Posted : January 30, 2017
Last Update Posted : January 29, 2018
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Condition or disease | Intervention/treatment | Phase |
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Vojta Therapy Reflex Locomotion | Other: Vojta therapy Other: conventional physiotherapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Masking Description: | The assessor for the secondary outcome (Barthel Index and mRS after 90 days) is blinded. All other outcome assessors have knowledge of the interventions assigned to individual participants. |
Primary Purpose: | Treatment |
Official Title: | Improvement of Postural Control and Motor Function by Vojta Therapy in Early Stroke Rehabilitation of Stroke Patients - a Pilot Study and New Approach in Stroke Rehabilitation |
Actual Study Start Date : | December 2, 2015 |
Actual Primary Completion Date : | April 14, 2017 |
Actual Study Completion Date : | July 4, 2017 |

Arm | Intervention/treatment |
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Experimental: Vojta arm
Patients in the interventional arm are treated with Vojta therapy from randomization until discharge.
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Other: Vojta therapy
Other Name: reflex locomotion |
Active Comparator: conventional physiotherapy arm
Patients in this control arm are treated with conventional physiotherapy for motor improvement from randomization until discharge.
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Other: conventional physiotherapy |
- Improvement of postural control measured with the trunc control test (TCT) on day 9 after admission to the hospital [ Time Frame: Day 1-9 after admission to hospital (+/- 1) ]The Trunc Control Test (TCT) is a valid test to asses motor impairment after stroke. A range of 0 to 100 points can be achieved. Patients are tested before the first treatment on day 2, after 5 days and after the last intervention on day 9 (+/-1) after admission to hospital.
- Improvement of neglect measured with the Catherine Bergego Scale (part 5 and 6) after on day 9 after admission to the hospital (compared to baseline) [ Time Frame: Day 1-9 after hospital admission (+/- 1) ]The neglect is assessed with part 5 and 6 of the Catherine Bergego Scale. Patients are tested before and after the first treatment on day 2, before and after treatment after 5 days and before and after the last intervention on day 9 (+/-1) after admission to hospital.
- Improvement of arm motor function measured with the motor evaluation scale for upper extremity in stroke patients [MESUPES, part 1 to 4] on day 9 after admission to the hospital (compared to baseline) [ Time Frame: Day 1-9 after hospital admission (+/- 1) ]The arm motor function is assessed with part 1 to 4 of the MESUPES. Patients are tested before and after the first treatment on day 2, before and after treatment after 5 days and before and after the last intervention on day 9 (+/-1) after admission to hospital.
- Improvement of the Barthel Index on day 9 after admission to the hospital [ Time Frame: Day 1-9 after hospital admission (+/- 1) ]The Barthel Index is assessed before the first treatment on day 2 and after the last intervention on day 9 (+/-1) after admission to hospital.
- Improvement of the NIHSS on day 9 after admission to the hospital [ Time Frame: Day 1-9 after hospital admission (+/- 1) ]The NIHSS is assessed before the first treatment on day 2 and after the last intervention on day 9 (+/-1) after admission to hospital.
- Improvement of the neglect (measured with the Catherine Bergego Scale) before and after every single intervention. [ Time Frame: Day 1-9. ]Patients are assessed for the neglect 3 times: on day 2, day 5 and day 9 (plus/minus 1 day) after admission to hospital before and after treatment. We want to compare if there is an improvement of the neglect directly after treatment.
- Improvement of arm motor function (measured with the MESUPES) before and after every single intervention. [ Time Frame: Day 1-9. ]Patients are assessed for the motor function 3 times: on day 2, day 5 and day 9 (plus/minus 1 day) after admission to hospital before and after treatment. We want to compare if there is an improvement of motor function directly after treatment.
- Improvement of the modified Rankin Scale (mRS) on day 90 after stroke onset [ Time Frame: Day 90 after stroke onset ]The mRS is assessed before the first treatment on day 2 after admission to hospital (before treatment) and on day 90 after stroke onset. The 90 day mRS is assessed via telephone interview by a blinded assessor
- Improvement of the Barthel Index on day 90 after stroke onset [ Time Frame: Day 90 after stroke onset ]The Barthel Index is assessed before the first treatment on day 2 after admission to hospital (before treatment) and on day 90 after stroke onset. The 90 day Barthel Index is assessed via telephone interview by a blinded assessor

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult patients (> 18 years)
- CT or MRI proven acute ischemic (AIS) or hemorrhagic stroke (ICH) within 72h after onset of symptoms
- Severe hemiparesis (medical research council scale for muscle strength ≤2)
- premorbid modified Rankin Scale (mRS) ≤3
- maximal National Institute of Health Stroke Scale Score (NIHSS) 25
- Voluntary written consent by the patient
Exclusion Criteria:
- Severe cognitive impairment due to aphasia or dementia, prohibiting that physiotherapeutic challenges can be understood.
- Participation on another clinical trial
- Pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035968
Germany | |
Klinikum Frankfurt Höchst | |
Frankfurt am Main, Hessen, Germany, 60311 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Corina Epple, Principle Investigator, Klinikum Frankfurt Höchst |
ClinicalTrials.gov Identifier: | NCT03035968 |
Other Study ID Numbers: |
Höchster Vojta Stroke Studie |
First Posted: | January 30, 2017 Key Record Dates |
Last Update Posted: | January 29, 2018 |
Last Verified: | January 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Vojta therapy reflex locomotion stroke rehabilitation stroke physiotherapy |
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |