Vojta Therapy in Early Stroke Rehabilitation

January 26, 2018 updated by: Corina Epple

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

Stroke is the major cause for permanent disability in adults. It is still unclear, which physiotherapeutic approaches are most effective. The Bobath-concept is one of the most widely used approaches in stroke rehabilitation within the western world, although several studies have failed to demonstrate superiority and showed partially even inferiority compared to other physiotherapy approaches. The Vojta therapy is based on a completely different approach - the reflex locomotion. However to date no study has been performed for stroke. We designed a randomized clinical trial (RCT) to compare Vojta and conventional physiotherapy in patients with acute ischemic (AIS) or hemorrhagic stroke (ICH). This RCT will be the first trial to investigate improvement of postural control due to Vojta therapy in early rehabilitation of stroke patients, which is a very new approach in stroke-rehabilitation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60311
        • Klinikum Frankfurt Höchst

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vojta arm
Patients in the interventional arm are treated with Vojta therapy from randomization until discharge.
Other: Vojta therapy
Other Names:
  • reflex locomotion
Active Comparator: conventional physiotherapy arm
Patients in this control arm are treated with conventional physiotherapy for motor improvement from randomization until discharge.
Other: conventional physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1-9 after admission to hospital (+/- 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1-9 after hospital admission (+/- 1)
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.
Day 1-9 after hospital admission (+/- 1)
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.
Day 1-9 after hospital admission (+/- 1)
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.
Day 1-9 after hospital admission (+/- 1)
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.
Day 1-9.
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.
Day 1-9.
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
Day 90 after stroke onset
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
Day 90 after stroke onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corina Epple

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2015

Primary Completion (Actual)

April 14, 2017

Study Completion (Actual)

July 4, 2017

Study Registration Dates

First Submitted

January 24, 2017

First Submitted That Met QC Criteria

January 25, 2017

First Posted (Estimate)

January 30, 2017

Study Record Updates

Last Update Posted (Actual)

January 29, 2018

Last Update Submitted That Met QC Criteria

January 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Höchster Vojta Stroke Studie

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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